SB 752: Pharmacy: designated representative-reverse distributors.
- Session Year: 2017-2018
- House: Senate
- Latest Version Date: 2017-10-08
The Pharmacy Law provides for the licensure and regulation of pharmacists and other persons involved in the handling, storage, sale, or disposal of drugs and devices by the California State Board of Pharmacy in the Department of Consumer Affairs. That law requires a person acting as a reverse distributor to be licensed by the board as a wholesaler and supervised or managed by a designated representative or pharmacist, as specified. A violation of that law is a crime, unless otherwise provided.
This bill would authorize a wholesaler that only acts as a reverse distributor to operate under the supervision of a designated representative-reverse distributor, as an alternative to operating under the supervision of a designated representative or pharmacist, and would provide for the separate licensure of individuals as designated representative-reverse distributors upon application, payment of an application fee, and completion of certain requirements. The bill would make related and conforming changes, including requiring designated representative-reverse distributors and designated representative-3PLs to notify the executive officer of the board of a change of name or address. The bill would specify that persons who act as agents for pharmacies or other entities by receiving, inventorying, warehousing, and managing the disposition of outdated or nonsaleable dangerous devices are reverse distributors. By modifying the scope of a crime, this bill would impose a state-mandated local program.
Existing law provides that an applicant for a pharmaceutical license who fails the national examination be required to wait at least 90 days before being permitted to retake the examination.
This bill would provide that an applicant who fails either the North American Pharmacist Licensure Examination or the California Practice Standards and Jurisprudence Examination for Pharmacists, be required to wait at least 45 days before being permitted to retake the examination unless the board establishes a different waiting period.
This bill would incorporate additional changes to Section 4059.5 of the Business and Professions Code proposed by AB 401, that would become operative only if AB 401 and this bill are both chaptered and become effective on or before January 1, 2018, and this bill is chaptered last.
This bill would incorporate additional changes to Section 4400 of the Business and Professions Code proposed by SB 351, that would become operative only if SB 351 and this bill are both chaptered and become effective on or before January 1, 2018, and this bill is chaptered last.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
The Pharmacy Law provides for the licensure and regulation of pharmacists and other persons involved in the handling, storage, sale, or disposal of drugs and devices by the California State Board of Pharmacy in the Department of Consumer Affairs. That law requires a person acting as a reverse distributor to be licensed by the board as a wholesaler and supervised or managed by a designated representative or pharmacist, as specified. A violation of that law is a crime, unless otherwise provided.
This bill would authorize a wholesaler that only acts as a reverse distributor to operate under the supervision of a designated representative-reverse distributor, as an alternative to operating under the supervision of a designated representative or pharmacist, and would provide for the separate licensure of individuals as designated representative-reverse distributors upon application, payment of an application fee, and completion of certain requirements. The bill would make related and conforming changes, including requiring designated representative-reverse distributors and designated representative-3PLs to notify the executive officer of the board of a change of name or address. The bill would specify that persons who act as agents for pharmacies or other entities by receiving, inventorying, warehousing, and managing the disposition of outdated or nonsaleable dangerous devices are reverse distributors. By modifying the scope of a crime, this bill would impose a state-mandated local program.
Existing law provides that an applicant for a pharmaceutical license who fails the national examination be required to wait at least 90 days before being permitted to retake the examination.
This bill would provide that an applicant who fails either the North American Pharmacist Licensure Examination or the California Practice Standards and Jurisprudence Examination for Pharmacists, be required to wait at least 45 days before being permitted to retake the examination unless the board establishes a different waiting period.
This bill would incorporate additional changes to Section 4059.5 of the Business and Professions Code proposed by AB 401, that would become operative only if AB 401 and this bill are both chaptered and become effective on or before January 1, 2018, and this bill is chaptered last.
This bill would incorporate additional changes to Section 4400 of the Business and Professions Code proposed by SB 351, that would become operative only if SB 351 and this bill are both chaptered and become effective on or before January 1, 2018, and this bill is chaptered last.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
The Pharmacy Law provides for the licensure and regulation of pharmacists and other persons involved in the handling, storage, sale, or disposal of drugs and devices by the California State Board of Pharmacy in the Department of Consumer Affairs. That law requires a person acting as a reverse distributor to be licensed by the board as a wholesaler and supervised or managed by a designated representative or pharmacist, as specified. A violation of that law is a crime, unless otherwise provided.
This bill would authorize a wholesaler that only acts as a reverse distributor to operate under the supervision of a designated representative-reverse distributor, as an alternative to operating under the supervision of a designated representative or pharmacist, and would provide for the separate licensure of individuals as designated representative-reverse distributors upon application, payment of an application fee, and completion of certain requirements. The bill would make related and conforming changes, including requiring designated representative-reverse distributors and designated representative-3PLs to notify the executive officer of the board of a change of name or address. The bill would specify that persons who act as agents for pharmacies or other entities by receiving, inventorying, warehousing, and managing the disposition of outdated or nonsaleable dangerous devices are reverse distributors. By modifying the scope of a crime, this bill would impose a state-mandated local program.
Existing law provides that an applicant for a pharmaceutical license who fails the national examination be required to wait at least 90 days before being permitted to retake the examination.
This bill would provide that an applicant who fails either the North American Pharmacist Licensure Examination or the California Practice Standards and Jurisprudence Examination for Pharmacists, be required to wait at least 45 days before being permitted to retake the examination unless the board establishes a different waiting period.
This bill would incorporate additional changes to Section 4059.5 of the Business and Professions Code proposed by AB 401, that would become operative only if AB 401 and this bill are both chaptered and become effective on or before January 1, 2018, and this bill is chaptered last.
This bill would incorporate additional changes to Section 4400 of the Business and Professions Code proposed by SB 351, that would become operative only if SB 351 and this bill are both chaptered and become effective on or before January 1, 2018, and this bill is chaptered last.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
The Pharmacy Law provides for the licensure and regulation of pharmacists and other persons involved in the handling, storage, sale, or disposal of drugs and devices by the California State Board of Pharmacy in the Department of Consumer Affairs. That law requires a person acting as a reverse distributor to be licensed by the board as a wholesaler and supervised or managed by a designated representative or pharmacist, as specified. A reverse distributor includes every person who acts as an agent for pharmacies, drug wholesalers, third-party logistics (3PL) providers, manufacturers, and other entities by receiving, inventorying, warehousing, and managing the disposition of outdated or nonsaleable dangerous drugs. A violation of that law is a crime, unless otherwise provided.
This bill would authorize a wholesaler that only acts as a reverse distributor to operate under the supervision of a designated representative-reverse distributor, as an alternative to operating under the supervision of a designated representative or pharmacist, and would provide for the separate licensure of individuals as designated representative-reverse distributors upon application, payment of an application fee, and completion of certain requirements. The bill would make related and conforming changes, including requiring designated representative-reverse distributors and designated representative-3PLs to notify the executive officer of the board of a change of name or address. The bill would specify that persons who act as agents for pharmacies or other entities by receiving, inventorying, warehousing, and managing the disposition of outdated or nonsaleable dangerous devices are reverse distributors. By modifying the scope of a crime, this bill would impose a state-mandated local program.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
The Pharmacy Law provides for the licensure and regulation of pharmacists and other persons involved in the handling, storage, sale, or disposal of drugs and devices by the California State Board of Pharmacy in the Department of Consumer Affairs. That law requires a person acting as a reverse distributor to be licensed by the board as a wholesaler and supervised or managed by a designated representative or pharmacist, as specified. A violation of that law is a crime, unless otherwise provided.
This bill would authorize a wholesaler that only acts as a reverse distributor to operate under the supervision of a designated representative-reverse distributor, as an alternative to operating under the supervision of a designated representative or pharmacist, and would provide for the separate licensure of individuals as designated representative-reverse distributors upon application, payment of an application fee, and completion of certain requirements. The bill would make related and conforming changes, including requiring designated representative-reverse distributors and designated representative-3PLs to notify the executive officer of the board of a change of name or address. The bill would specify that persons who act as agents for pharmacies or other entities by receiving, inventorying, warehousing, and managing the disposition of outdated or nonsaleable dangerous devices are reverse distributors. By modifying the scope of a crime, this bill would impose a state-mandated local program.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
Existing law authorizes a county to develop and establish a program for the collection of banned, unregistered, or outdated agricultural waste from an eligible participant. Existing law requires a county participating in the program to conduct a survey to identify all eligible participants in the county to assess the amount, kind, and condition of the banned, unregistered, or outdated agricultural waste that will be collected by the program.This bill would make nonsubstantive changes to the survey provision.Existing law authorizes a county to develop and establish a program for the collection of banned, unregistered, or outdated agricultural waste from an eligible participant. Existing law requires a county participating in the program to conduct a survey to identify all eligible participants in the county to assess the amount, kind, and condition of the banned, unregistered, or outdated agricultural waste that will be collected by the program.
This bill would make nonsubstantive changes to the survey provision.
(a)Designated representative means an individual to whom a license has been granted pursuant to Section 4053. A pharmacist fulfilling the duties of Section 4053 shall not be required to obtain a license as a designated representative.
(b)Designated representative-in-charge means a designated representative or designated representative-reverse distributor, or a pharmacist proposed by a wholesaler or veterinary food-animal drug retailer and approved by the board as the supervisor or manager responsible for ensuring the wholesalers or veterinary food-animal drug retailers compliance with all state and federal laws and regulations pertaining to practice in the applicable license category.
SEC. 2.Section 4022.6 is added to the Business and Professions Code, to read:4022.6.Designated representative-reverse distributor means an individual to whom a license has been granted pursuant to Section 4053.2, who is responsible for supervision over a licensed wholesaler that only acts as a reverse distributor. A pharmacist fulfilling the duties of Section 4053.2 shall not be required to obtain a license as a designated representative-reverse distributor.
SEC. 3.Section 4040.5 of the Business and Professions Code is amended to read:4040.5.Reverse distributor means every person who acts as an agent for pharmacies, drug wholesalers, third-party logistics providers, manufacturers, and other entities by receiving, inventorying, warehousing, and managing the disposition of outdated or nonsaleable dangerous drugs or dangerous devices.
SEC. 4.Section 4053.2 is added to the Business and Professions Code, to read:4053.2.(a)Notwithstanding Sections 4051 and 4053, the board may issue a designated representative-reverse distributor license to a qualified individual who shall provide sufficient and qualified supervision over a licensed wholesaler that only acts as a reverse distributor. The designated representative-reverse distributor shall protect the public health and safety in the handling, storage, warehousing, and destruction of outdated or nonsaleable dangerous drugs and dangerous devices.
(b)An individual who is at least 18 years of age may apply for a designated representative-reverse distributor license. In order to obtain and maintain that license, the individual shall meet all of the following requirements:
(1)He or she shall be a high school graduate or possess a general education development certificate equivalent.
(2)He or she shall meet one of the following requirements:
(A)Have a minimum of one year of paid work experience in the past three years with a licensed wholesaler, third-party logistics provider, or pharmacy performing duties related to the distribution, dispensing, or destruction of dangerous drugs or dangerous devices.
(B)Have a minimum of one year of paid work experience in the destruction of outdated or nonsaleable dangerous drugs or dangerous devices pharmaceutical waste.
(C)Meet all of the prerequisites to take the examination required for licensure as a pharmacist by the board.
(3)(A)He or she shall complete a training program approved by the board that, at a minimum, addresses each of the following subjects:
(i)Knowledge and understanding of California law and federal law relating to the distribution of dangerous drugs and dangerous devices.
(ii)Knowledge and understanding of California law and federal law relating to the distribution of controlled substances.
(iii)Knowledge and understanding of California law and federal law relating to the removal and destruction of dangerous drugs, dangerous devices, and pharmaceutical waste.
(iv)Knowledge and understanding of the United States Pharmacopoeia or federal Food and Drug Administration standards relating to the safe storage, handling, and transport of dangerous drugs and dangerous devices.
(B)The board may, by regulation, require the training program required under this paragraph to include additional material.
(C)The board shall not issue a license as a designated representative-reverse distributor until the applicant provides proof of completion of the training required by this paragraph to the board.
(c)A reverse distributor shall not operate without at least one designated representative or designated representative-reverse distributor present at each of its licensed places of business as required under Section 4160.
SEC. 5.Section 4059.5 of the Business and Professions Code is amended to read:4059.5.(a)Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and shall be delivered to the licensed premises and signed for and received by a pharmacist. Where a licensee is permitted to operate through a designated representative, or in the case of a reverse distributor a designated representative-reverse distributor, that individual shall sign for and receive the delivery.
(b)A dangerous drug or dangerous device transferred, sold, or delivered to a person within this state shall be transferred, sold, or delivered only to an entity licensed by the board, to a manufacturer, or to an ultimate user or the ultimate users agent.
(c)Notwithstanding subdivisions (a) and (b), deliveries to a hospital pharmacy may be made to a central receiving location within the hospital. However, the dangerous drugs or dangerous devices shall be delivered to the licensed pharmacy premises within one working day following receipt by the hospital, and the pharmacist on duty at that time shall immediately inventory the dangerous drugs or dangerous devices.
(d)Notwithstanding any other law, a dangerous drug or dangerous device may be ordered by and provided to a manufacturer, physician, dentist, podiatrist, optometrist, veterinarian, naturopathic doctor pursuant to Section 3640.7, or laboratory, or a physical therapist acting within the scope of his or her license. A person or entity receiving delivery of a dangerous drug or dangerous device, or a duly authorized representative of the person or entity, shall sign for the receipt of the dangerous drug or dangerous device.
(e)A dangerous drug or dangerous device shall not be transferred, sold, or delivered to a person outside this state, whether foreign or domestic, unless the transferor, seller, or deliverer does so in compliance with the laws of this state and of the United States and of the state or country to which the dangerous drugs or dangerous devices are to be transferred, sold, or delivered. Compliance with the laws of this state and the United States and of the state or country to which the dangerous drugs or dangerous devices are to be delivered shall include, but not be limited to, determining that the recipient of the dangerous drugs or dangerous devices is authorized by law to receive the dangerous drugs or dangerous devices.
(f)Notwithstanding subdivision (a), a pharmacy may take delivery of dangerous drugs and dangerous devices when the pharmacy is closed and no pharmacist is on duty if all of the following requirements are met:
(1)The drugs are placed in a secure storage facility in the same building as the pharmacy.
(2)Only the pharmacist-in-charge or a pharmacist designated by the pharmacist-in-charge has access to the secure storage facility after dangerous drugs or dangerous devices have been delivered.
(3)The secure storage facility has a means of indicating whether it has been entered after dangerous drugs or dangerous devices have been delivered.
(4)The pharmacy maintains written policies and procedures for the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(5)The agent delivering dangerous drugs and dangerous devices pursuant to this subdivision leaves documents indicating the name and amount of each dangerous drug or dangerous device delivered in the secure storage facility.
The pharmacy shall be responsible for the dangerous drugs and dangerous devices delivered to the secure storage facility. The pharmacy shall also be responsible for obtaining and maintaining records relating to the delivery of dangerous drugs and dangerous devices to a secure storage facility.
SEC. 5.5.Section 4059.5 of the Business and Professions Code is amended to read:4059.5.(a)Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and shall be delivered to the licensed premises and signed for and received by a pharmacist. Where a licensee is permitted to operate through a designated representative, or in the case of a reverse distributor a designated representative-reverse distributor, that individual shall sign for and receive the delivery.
(b)A dangerous drug or dangerous device transferred, sold, or delivered to a person within this state shall be transferred, sold, or delivered only to an entity licensed by the board, to a manufacturer, or to an ultimate user or the ultimate users agent.
(c)Notwithstanding subdivisions (a) and (b), deliveries to a hospital pharmacy may be made to a central receiving location within the hospital. However, the dangerous drugs or dangerous devices shall be delivered to the licensed pharmacy premises within one working day following receipt by the hospital, and the pharmacist on duty at that time shall immediately inventory the dangerous drugs or dangerous devices.
(d)Notwithstanding any other law, a dangerous drug or dangerous device may be ordered by and provided to a manufacturer, physician, dentist, podiatrist, optometrist, veterinarian, naturopathic doctor pursuant to Section 3640.7, or laboratory, or a physical therapist acting within the scope of his or her license. A person or entity receiving delivery of a dangerous drug or dangerous device, or a duly authorized representative of the person or entity, shall sign for the receipt of the dangerous drug or dangerous device.
(e)A dangerous drug or dangerous device shall not be transferred, sold, or delivered to a person outside this state, whether foreign or domestic, unless the transferor, seller, or deliverer does so in compliance with the laws of this state and of the United States and of the state or country to which the dangerous drugs or dangerous devices are to be transferred, sold, or delivered. Compliance with the laws of this state and the United States and of the state or country to which the dangerous drugs or dangerous devices are to be delivered shall include, but not be limited to, determining that the recipient of the dangerous drugs or dangerous devices is authorized by law to receive the dangerous drugs or dangerous devices.
(f)Notwithstanding subdivision (a), a pharmacy may take delivery of dangerous drugs and dangerous devices when the pharmacy is closed and no pharmacist is on duty if all of the following requirements are met:
(1)The drugs are placed in a secure storage facility in the same building as the pharmacy.
(2)Only the pharmacist-in-charge or a pharmacist designated by the pharmacist-in-charge has access to the secure storage facility after dangerous drugs or dangerous devices have been delivered.
(3)The secure storage facility has a means of indicating whether it has been entered after dangerous drugs or dangerous devices have been delivered.
(4)The pharmacy maintains written policies and procedures for the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(5)The agent delivering dangerous drugs and dangerous devices pursuant to this subdivision leaves documents indicating the name and amount of each dangerous drug or dangerous device delivered in the secure storage facility.
The pharmacy shall be responsible for the dangerous drugs and dangerous devices delivered to the secure storage facility. The pharmacy shall also be responsible for obtaining and maintaining records relating to the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(g)Notwithstanding subdivision (a), dangerous drugs and devices and controlled substances may be ordered by a remote dispensing site pharmacy licensed by the board and may be signed for and received by a registered pharmacy technician, who meets the qualifications of Section 4132, at the remote site. A controlled substance signed for by a pharmacy technician under this section shall be stored separately from existing inventory until the time the controlled substance is reviewed and countersigned by a pharmacist. Any receipt and storage of a controlled substance by a pharmacy technician pursuant to this section shall be captured on video, and that video shall be made accessible to the supervising pharmacy and maintained by the remote dispensing site pharmacy for 120 days.
SEC. 6.Section 4100 of the Business and Professions Code is amended to read:4100.Within 30 days after changing his or her address of record with the board or after changing his or her name according to law, a pharmacist, intern pharmacist, technician, designated representative, designated representative-3PL, or designated representative-reverse distributor shall notify the executive officer of the board of the change of address or change of name.
SEC. 7.Section 4160 of the Business and Professions Code is amended to read:4160.(a)A person shall not act as a wholesaler or third-party logistics provider of any dangerous drug or dangerous device unless he or she has obtained a license from the board.
(b)Upon approval by the board and the payment of the required fee, the board shall issue a license to the applicant.
(c)(1)A separate license shall be required for each place of business owned or operated by a wholesaler or third-party logistics provider. Each place of business may only be issued a single license by the board, except as provided in paragraph (2). Each license shall be renewed annually and shall not be transferable. At all times during which a place of business is open for business, at least one designated representative, in the case of a wholesaler, or designated representative-3PL in the case of a third-party logistics provider, shall be present. A wholesaler that only acts as a reverse distributor may use either a designated representative or a designated representative-reverse distributor to fulfill this requirement.
(2)A wholesaler and a third-party logistics provider under common ownership may be licensed at the same place of business provided that all of the following requirements are satisfied:
(A)The wholesaler and the third-party logistics provider each separately maintain the records required under Section 4081.
(B)Dangerous drugs and dangerous devices owned by the wholesaler are not commingled with the dangerous drugs and dangerous devices handled by the third-party logistics provider.
(C)Any individual acting as a designated representative for the wholesaler is not concurrently acting as a designated representative-3PL on behalf of the third-party logistics provider. Nothing in this subparagraph shall be construed to prohibit an individual from concurrently holding a license to act as a designated representative and to act as a designated representative-3PL.
(D)The wholesaler has its own designated representative-in-charge responsible for the operations of the wholesaler and the third-party logistics provider has its own responsible manager responsible for the operations of the third-party logistics provider. The same individual shall not concurrently serve as the responsible manager and the designated representative-in-charge for a wholesaler and a third-party logistics provider licensed at the same place of business.
(E)The third-party logistics provider does not handle the prescription drugs or prescription devices owned by a prescriber.
(F)The third-party logistics provider is not a reverse third-party logistics provider.
(G)The wholesaler is not acting as a reverse distributor.
(d)Every wholesaler shall be supervised or managed by a designated representative-in-charge. The designated representative-in-charge shall be responsible for the wholesalers compliance with state and federal laws governing wholesalers. As part of its initial application for a license, and for each renewal, each wholesaler shall, on a form designed by the board, provide identifying information and the California license number for a designated representative or pharmacist proposed to serve as the designated representative-in-charge. The proposed designated representative-in-charge shall be subject to approval by the board. The board shall not issue or renew a wholesaler license without identification of an approved designated representative-in-charge for the wholesaler. The designated representative-in-charge shall maintain an active license as a designated representative with the board at all times during which he or she is designated as the designated representative-in-charge. A wholesaler that only acts as a reverse distributor may identify and allow a designated representative-reverse distributor to perform in this capacity. That individual shall maintain an active license as a designated representative-reverse distributor.
(e)Each place of business of a third-party logistics provider shall be supervised and managed by a responsible manager. The responsible manager shall be responsible for the compliance of the place of business with state and federal laws governing third-party logistics providers and with the third-party logistics providers customer specifications, except where the customers specifications conflict with state or federal laws. As part of its initial application for a license, and for each renewal, each third-party logistics provider shall, on a form designated by the board, provide identifying information and the California license number for a designated representative-3PL proposed to serve as the responsible manager. The proposed responsible manager shall be subject to approval by the board. The board shall not issue or renew a third-party logistics provider license without identification of an approved responsible manager for the third-party logistics provider. The responsible manager shall maintain an active license as a designated representative-3PL with the board at all times during which he or she is designated as the responsible manager.
(f)A wholesaler shall notify the board in writing, on a form designed by the board, within 30 days of the date when a designated representative-in-charge ceases to act as the designated representative-in-charge, and shall on the same form propose another authorized licensee to take over as the designated representative-in-charge. The proposed replacement designated representative-in-charge shall be subject to approval by the board. If disapproved, the wholesaler shall propose another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a designated representative-in-charge is approved by the board.
(g)A third-party logistics provider shall notify the board in writing, on a form designed by the board, within 30 days of the date when a responsible manager ceases to act as the responsible manager, and shall on the same form propose another designated representative-3PL to take over as the responsible manager. The proposed replacement responsible manager shall be subject to approval by the board. If disapproved, the third-party logistics provider shall propose another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a responsible manager is approved by the board.
(h)A drug manufacturer premises licensed by the Food and Drug Administration or licensed pursuant to Section 111615 of the Health and Safety Code that only distributes dangerous drugs and dangerous devices of its own manufacture is exempt from this section and Section 4161.
(i)The board may issue a temporary license, upon conditions and for periods of time as the board determines to be in the public interest. A temporary license fee shall be required in an amount established by the board as specified in subdivision (f) of Section 4400. When needed to protect public safety, a temporary license may be issued for a period not to exceed 180 days, subject to terms and conditions that the board deems necessary. If the board determines that a temporary license was issued by mistake or denies the application for a permanent license, the temporary license shall terminate upon either personal service of the notice of termination upon the licenseholder or service by certified mail, return receipt requested, at the licenseholders address of record with the board, whichever occurs first. For purposes of retaining a temporary license, or for purposes of any disciplinary or license denial proceeding before the board, the temporary licenseholder shall not be deemed to have a vested property right or interest in the license.
SEC. 8.Section 4200.4 of the Business and Professions Code is amended to read:4200.4.An applicant who fails either the North American Pharmacist Licensure Examination or the California Practice Standards and Jurisprudence Examination for Pharmacists may not retake that examination for at least 45 days. The board may, in consultation with the Office of Professional Examination Services of the department, adopt a regulation establishing a different waiting period to retake the examination.
SEC. 9.Section 4331 of the Business and Professions Code is amended to read:4331.(a)A person not authorized under this chapter who takes charge of a wholesaler or veterinary food-animal drug retailer or who dispenses a prescription or furnishes dangerous devices, except as otherwise provided in this chapter, is guilty of a misdemeanor.
(b)A person who is not a responsible manager or a designated representative-3PL who takes charge of a third-party logistics provider or coordinates the warehousing or distribution of dangerous drugs or dangerous devices within a third-party logistics provider, except as otherwise provided in this chapter, is guilty of a misdemeanor.
(c)A person licensed as a veterinary food-animal drug retailer that fails to place in charge of that veterinary food-animal drug retailer a pharmacist or designated representative, or any person who, by himself or herself, or by any other person, permits the dispensing of prescriptions, except by a pharmacist or designated representative, or as otherwise provided in this chapter, is guilty of a misdemeanor.
(d)A person licensed as a wholesaler that fails to place in charge of that wholesaler a pharmacist or designated representative, or any person who, by himself or herself, or by any other person, permits the furnishing of dangerous drugs or dangerous devices, except by a pharmacist or designated representative, or as otherwise provided in this chapter, is guilty of a misdemeanor.
(e)A person licensed as a third-party logistics provider that fails to place in charge of a licensed place of business of the third-party logistics provider a responsible manager, or any person who, by himself or herself, or by any other person, permits the furnishing of dangerous drugs or dangerous devices, except by a facility manager, or as otherwise provided in this chapter, is guilty of a misdemeanor.
SEC. 10.Section 4400 of the Business and Professions Code, as added by Section 26 of Chapter 799 of the Statutes of 2016, is amended to read:4400.The amount of fees and penalties prescribed by this chapter, except as otherwise provided, is that fixed by the board according to the following schedule:
(a)The fee for a nongovernmental pharmacy license shall be five hundred twenty dollars ($520) and may be increased to five hundred seventy dollars ($570). The fee for the issuance of a temporary nongovernmental pharmacy permit shall be two hundred fifty dollars ($250) and may be increased to three hundred twenty-five dollars ($325).
(b)The fee for a nongovernmental pharmacy license annual renewal shall be six hundred sixty-five dollars ($665) and may be increased to nine hundred thirty dollars ($930).
(c)The fee for the pharmacist application and examination shall be two hundred sixty dollars ($260) and may be increased to two hundred eighty-five dollars ($285).
(d)The fee for regrading an examination shall be ninety dollars ($90) and may be increased to one hundred fifteen dollars ($115). If an error in grading is found and the applicant passes the examination, the regrading fee shall be refunded.
(e)The fee for a pharmacist license shall be one hundred ninety-five dollars ($195) and may be increased to two hundred fifteen dollars ($215). The fee for a pharmacist biennial renewal shall be three hundred sixty dollars ($360) and may be increased to five hundred five dollars ($505).
(f)The fee for a nongovernmental wholesaler or third-party logistics provider license and annual renewal shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(g)The fee for a hypodermic license shall be one hundred seventy dollars ($170) and may be increased to two hundred forty dollars ($240). The fee for a hypodermic license renewal shall be two hundred dollars ($200) and may be increased to two hundred eighty dollars ($280).
(h)(1)The fee for application, investigation, and issuance of a license as a designated representative pursuant to Section 4053, as a designated representative-3PL pursuant to Section 4053.1, or as a designated representative-reverse distributor pursuant to Section 4053.2 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative, designated representative-3PL, or designated representative-reverse distributor shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(i)(1)The fee for the application, investigation, and issuance of a license as a designated representative for a veterinary food-animal drug retailer pursuant to Section 4053 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative for a veterinary food-animal drug retailer shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(j)(1)The application fee for a nonresident wholesaler or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(2)For nonresident wholesalers or third-party logistics providers that have 21 or more facilities operating nationwide the application fees for the first 20 locations shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(3)The annual renewal fee for a nonresident wholesaler license or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(k)The fee for evaluation of continuing education courses for accreditation shall be set by the board at an amount not to exceed forty dollars ($40) per course hour.
(l)The fee for an intern pharmacist license shall be one hundred sixty-five dollars ($165) and may be increased to two hundred thirty dollars ($230). The fee for transfer of intern hours or verification of licensure to another state shall be twenty-five dollars ($25) and may be increased to thirty dollars ($30).
(m)The board may waive or refund the additional fee for the issuance of a license where the license is issued less than 45 days before the next regular renewal date.
(n)The fee for the reissuance of any license, or renewal thereof, that has been lost or destroyed or reissued due to a name change shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(o)The fee for the reissuance of any license, or renewal thereof, that must be reissued because of a change in the information, shall be one hundred dollars ($100) and may be increased to one hundred thirty dollars ($130).
(p)It is the intent of the Legislature that, in setting fees pursuant to this section, the board shall seek to maintain a reserve in the Pharmacy Board Contingent Fund equal to approximately one years operating expenditures.
(q)The fee for any applicant for a nongovernmental clinic license shall be five hundred twenty dollars ($520) for each license and may be increased to five hundred seventy dollars ($570). The annual fee for renewal of the license shall be three hundred twenty-five dollars ($325) for each license and may be increased to three hundred sixty dollars ($360).
(r)The fee for the issuance of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195). The fee for renewal of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195).
(s)The fee for a veterinary food-animal drug retailer license shall be four hundred thirty-five dollars ($435) and may be increased to six hundred ten dollars ($610). The annual renewal fee for a veterinary food-animal drug retailer license shall be three hundred thirty dollars ($330) and may be increased to four hundred sixty dollars ($460).
(t)The fee for issuance of a retired license pursuant to Section 4200.5 shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(u)The fee for issuance of a nongovernmental sterile compounding pharmacy license shall be one thousand six hundred forty-five dollars ($1,645) and may be increased to two thousand three hundred five dollars ($2,305). The fee for a temporary license shall be five hundred fifty dollars ($550) and may be increased to seven hundred fifteen dollars ($715). The annual renewal fee of the license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to one thousand eight hundred fifty-five dollars ($1,855).
(v)The fee for the issuance of a nonresident sterile compounding pharmacy license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to three thousand three hundred thirty-five dollars ($3,335). The annual renewal of the license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to three thousand one hundred eighty dollars ($3,180). In addition to paying that application fee, the nonresident sterile compounding pharmacy shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4127.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(w)The fee for the issuance of an outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. The fee for the renewal of an outsourcing facility license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to up to one thousand eight hundred fifty-five dollars ($1,855) by the board. The fee for a temporary outsourcing facility license shall be seven hundred fifteen dollars ($715).
(x)The fee for the issuance of a nonresident outsourcing facility license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to up to three thousand three hundred thirty-five dollars ($3,335) by the board. The fee for the renewal of a nonresident outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. In addition to paying that application fee, the nonresident outsourcing facility shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4129.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(y)The fee for the issuance of a centralized hospital packaging license shall be eight hundred twenty dollars ($820) and may be increased to one thousand one hundred fifty dollars ($1,150). The annual renewal of the license shall be eight hundred five dollars ($805) and may be increased to one thousand one hundred twenty-five dollars ($1,125).
(z)This section shall become operative on July 1, 2017.
SEC. 10.5.Section 4400 of the Business and Professions Code, as added by Section 26 of Chapter 799 of the Statutes of 2016, is amended to read:4400.The amount of fees and penalties prescribed by this chapter, except as otherwise provided, is that fixed by the board according to the following schedule:
(a)The fee for a nongovernmental pharmacy license shall be five hundred twenty dollars ($520) and may be increased to five hundred seventy dollars ($570). The fee for the issuance of a temporary nongovernmental pharmacy permit shall be two hundred fifty dollars ($250) and may be increased to three hundred twenty-five dollars ($325).
(b)The fee for a nongovernmental pharmacy license annual renewal shall be six hundred sixty-five dollars ($665) and may be increased to nine hundred thirty dollars ($930).
(c)The fee for the pharmacist application and examination shall be two hundred sixty dollars ($260) and may be increased to two hundred eighty-five dollars ($285).
(d)The fee for regrading an examination shall be ninety dollars ($90) and may be increased to one hundred fifteen dollars ($115). If an error in grading is found and the applicant passes the examination, the regrading fee shall be refunded.
(e)The fee for a pharmacist license shall be one hundred ninety-five dollars ($195) and may be increased to two hundred fifteen dollars ($215). The fee for a pharmacist biennial renewal shall be three hundred sixty dollars ($360) and may be increased to five hundred five dollars ($505).
(f)The fee for a nongovernmental wholesaler or third-party logistics provider license and annual renewal shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(g)The fee for a hypodermic license shall be one hundred seventy dollars ($170) and may be increased to two hundred forty dollars ($240). The fee for a hypodermic license renewal shall be two hundred dollars ($200) and may be increased to two hundred eighty dollars ($280).
(h)(1)The fee for application, investigation, and issuance of a license as a designated representative pursuant to Section 4053, as a designated representative-3PL pursuant to Section 4053.1, or as a designated representative-reverse distributor pursuant to Section 4053.2 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative, designated representative-3PL, or designated representative-reverse distributor shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(i)(1)The fee for the application, investigation, and issuance of a license as a designated representative for a veterinary food-animal drug retailer pursuant to Section 4053 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative for a veterinary food-animal drug retailer shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(j)(1)The application fee for a nonresident wholesaler or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(2)For nonresident wholesalers or third-party logistics providers that have 21 or more facilities operating nationwide the application fees for the first 20 locations shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(3)The annual renewal fee for a nonresident wholesaler license or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(k)The fee for evaluation of continuing education courses for accreditation shall be set by the board at an amount not to exceed forty dollars ($40) per course hour.
(l)The fee for an intern pharmacist license shall be one hundred sixty-five dollars ($165) and may be increased to two hundred thirty dollars ($230). The fee for transfer of intern hours or verification of licensure to another state shall be twenty-five dollars ($25) and may be increased to thirty dollars ($30).
(m)The board may waive or refund the additional fee for the issuance of a license where the license is issued less than 45 days before the next regular renewal date.
(n)The fee for the reissuance of any license, or renewal thereof, that has been lost or destroyed or reissued due to a name change shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(o)The fee for the reissuance of any license, or renewal thereof, that must be reissued because of a change in the information, shall be one hundred dollars ($100) and may be increased to one hundred thirty dollars ($130).
(p)It is the intent of the Legislature that, in setting fees pursuant to this section, the board shall seek to maintain a reserve in the Pharmacy Board Contingent Fund equal to approximately one years operating expenditures.
(q)The fee for any applicant for a nongovernmental clinic license shall be five hundred twenty dollars ($520) for each license and may be increased to five hundred seventy dollars ($570). The annual fee for renewal of the license shall be three hundred twenty-five dollars ($325) for each license and may be increased to three hundred sixty dollars ($360).
(r)The fee for the issuance of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195). The fee for renewal of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195).
(s)The fee for a veterinary food-animal drug retailer license shall be four hundred thirty-five dollars ($435) and may be increased to six hundred ten dollars ($610). The annual renewal fee for a veterinary food-animal drug retailer license shall be three hundred thirty dollars ($330) and may be increased to four hundred sixty dollars ($460).
(t)The fee for issuance of a retired license pursuant to Section 4200.5 shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(u)The fee for issuance of a nongovernmental sterile compounding pharmacy license or a hospital satellite compounding pharmacy shall be one thousand six hundred forty-five dollars ($1,645) and may be increased to two thousand three hundred five dollars ($2,305). The fee for a temporary license shall be five hundred fifty dollars ($550) and may be increased to seven hundred fifteen dollars ($715). The annual renewal fee of the license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to one thousand eight hundred fifty-five dollars ($1,855).
(v)The fee for the issuance of a nonresident sterile compounding pharmacy license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to three thousand three hundred thirty-five dollars ($3,335). The annual renewal of the license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to three thousand one hundred eighty dollars ($3,180). In addition to paying that application fee, the nonresident sterile compounding pharmacy shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4127.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(w)The fee for the issuance of an outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. The fee for the renewal of an outsourcing facility license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to up to one thousand eight hundred fifty-five dollars ($1,855) by the board. The fee for a temporary outsourcing facility license shall be seven hundred fifteen dollars ($715).
(x)The fee for the issuance of a nonresident outsourcing facility license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to up to three thousand three hundred thirty-five dollars ($3,335) by the board. The fee for the renewal of a nonresident outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. In addition to paying that application fee, the nonresident outsourcing facility shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4129.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(y)The fee for the issuance of a centralized hospital packaging license shall be eight hundred twenty dollars ($820) and may be increased to one thousand one hundred fifty dollars ($1,150). The annual renewal of the license shall be eight hundred five dollars ($805) and may be increased to one thousand one hundred twenty-five dollars ($1,125).
(z)This section shall become operative on July 1, 2017.
SEC. 11.Section 5.5 of this bill incorporates amendments to Section 4059.5 of the Business and Professions Code proposed by both this bill and Assembly Bill 401. That section shall only become operative if (1) both bills are enacted and become effective on or before January 1, 2018, (2) each bill amends Section 4059.5 of the Business and Professions Code, and (3) this bill is enacted after Assembly Bill 401, in which case Section 5 of this bill shall not become operative.
SEC. 12.Section 10.5 of this bill incorporates amendments to Section 4400 of the Business and Professions Code proposed by both this bill and Senate Bill 351. That section shall only become operative if (1) both bills are enacted and become effective on or before January 1, 2018, (2) each bill amends Section 4400 of the Business and Professions Code, and (3) this bill is enacted after Senate Bill 351, in which case Section 10 of this bill shall not become operative.
SEC. 13.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
(a)Designated representative means an individual to whom a license has been granted pursuant to Section 4053. A pharmacist fulfilling the duties of Section 4053 shall not be required to obtain a license as a designated representative.
(b)Designated representative-in-charge means a designated representative or designated representative-reverse distributor, or a pharmacist proposed by a wholesaler or veterinary food-animal drug retailer and approved by the board as the supervisor or manager responsible for ensuring the wholesalers or veterinary food-animal drug retailers compliance with all state and federal laws and regulations pertaining to practice in the applicable license category.
SEC. 2.Section 4022.6 is added to the Business and Professions Code, to read:4022.6.Designated representative-reverse distributor means an individual to whom a license has been granted pursuant to Section 4053.2, who is responsible for supervision over a licensed wholesaler that only acts as a reverse distributor. A pharmacist fulfilling the duties of Section 4053.2 shall not be required to obtain a license as a designated representative-reverse distributor.
SEC. 3.Section 4040.5 of the Business and Professions Code is amended to read:4040.5.Reverse distributor means every person who acts as an agent for pharmacies, drug wholesalers, third-party logistics providers, manufacturers, and other entities by receiving, inventorying, warehousing, and managing the disposition of outdated or nonsaleable dangerous drugs or dangerous devices.
SEC. 4.Section 4053.2 is added to the Business and Professions Code, to read:4053.2.(a)Notwithstanding Sections 4051 and 4053, the board may issue a designated representative-reverse distributor license to a qualified individual who shall provide sufficient and qualified supervision over a licensed wholesaler that only acts as a reverse distributor. The designated representative-reverse distributor shall protect the public health and safety in the handling, storage, warehousing, and destruction of outdated or nonsaleable dangerous drugs and dangerous devices.
(b)An individual who is at least 18 years of age may apply for a designated representative-reverse distributor license. In order to obtain and maintain that license, the individual shall meet all of the following requirements:
(1)He or she shall be a high school graduate or possess a general education development certificate equivalent.
(2)He or she shall meet one of the following requirements:
(A)Have a minimum of one year of paid work experience in the past three years with a licensed wholesaler, third-party logistics provider, or pharmacy performing duties related to the distribution, dispensing, or destruction of dangerous drugs or dangerous devices.
(B)Have a minimum of one year of paid work experience in the destruction of outdated or nonsaleable dangerous drugs or dangerous devices pharmaceutical waste.
(C)Meet all of the prerequisites to take the examination required for licensure as a pharmacist by the board.
(3)(A)He or she shall complete a training program approved by the board that, at a minimum, addresses each of the following subjects:
(i)Knowledge and understanding of California law and federal law relating to the distribution of dangerous drugs and dangerous devices.
(ii)Knowledge and understanding of California law and federal law relating to the distribution of controlled substances.
(iii)Knowledge and understanding of California law and federal law relating to the removal and destruction of dangerous drugs, dangerous devices, and pharmaceutical waste.
(iv)Knowledge and understanding of the United States Pharmacopoeia or federal Food and Drug Administration standards relating to the safe storage, handling, and transport of dangerous drugs and dangerous devices.
(B)The board may, by regulation, require the training program required under this paragraph to include additional material.
(C)The board shall not issue a license as a designated representative-reverse distributor until the applicant provides proof of completion of the training required by this paragraph to the board.
(c)A reverse distributor shall not operate without at least one designated representative or designated representative-reverse distributor present at each of its licensed places of business as required under Section 4160.
SEC. 5.Section 4059.5 of the Business and Professions Code is amended to read:4059.5.(a)Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and shall be delivered to the licensed premises and signed for and received by a pharmacist. Where a licensee is permitted to operate through a designated representative, or in the case of a reverse distributor a designated representative-reverse distributor, that individual shall sign for and receive the delivery.
(b)A dangerous drug or dangerous device transferred, sold, or delivered to a person within this state shall be transferred, sold, or delivered only to an entity licensed by the board, to a manufacturer, or to an ultimate user or the ultimate users agent.
(c)Notwithstanding subdivisions (a) and (b), deliveries to a hospital pharmacy may be made to a central receiving location within the hospital. However, the dangerous drugs or dangerous devices shall be delivered to the licensed pharmacy premises within one working day following receipt by the hospital, and the pharmacist on duty at that time shall immediately inventory the dangerous drugs or dangerous devices.
(d)Notwithstanding any other law, a dangerous drug or dangerous device may be ordered by and provided to a manufacturer, physician, dentist, podiatrist, optometrist, veterinarian, naturopathic doctor pursuant to Section 3640.7, or laboratory, or a physical therapist acting within the scope of his or her license. A person or entity receiving delivery of a dangerous drug or dangerous device, or a duly authorized representative of the person or entity, shall sign for the receipt of the dangerous drug or dangerous device.
(e)A dangerous drug or dangerous device shall not be transferred, sold, or delivered to a person outside this state, whether foreign or domestic, unless the transferor, seller, or deliverer does so in compliance with the laws of this state and of the United States and of the state or country to which the dangerous drugs or dangerous devices are to be transferred, sold, or delivered. Compliance with the laws of this state and the United States and of the state or country to which the dangerous drugs or dangerous devices are to be delivered shall include, but not be limited to, determining that the recipient of the dangerous drugs or dangerous devices is authorized by law to receive the dangerous drugs or dangerous devices.
(f)Notwithstanding subdivision (a), a pharmacy may take delivery of dangerous drugs and dangerous devices when the pharmacy is closed and no pharmacist is on duty if all of the following requirements are met:
(1)The drugs are placed in a secure storage facility in the same building as the pharmacy.
(2)Only the pharmacist-in-charge or a pharmacist designated by the pharmacist-in-charge has access to the secure storage facility after dangerous drugs or dangerous devices have been delivered.
(3)The secure storage facility has a means of indicating whether it has been entered after dangerous drugs or dangerous devices have been delivered.
(4)The pharmacy maintains written policies and procedures for the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(5)The agent delivering dangerous drugs and dangerous devices pursuant to this subdivision leaves documents indicating the name and amount of each dangerous drug or dangerous device delivered in the secure storage facility.
The pharmacy shall be responsible for the dangerous drugs and dangerous devices delivered to the secure storage facility. The pharmacy shall also be responsible for obtaining and maintaining records relating to the delivery of dangerous drugs and dangerous devices to a secure storage facility.
SEC. 5.5.Section 4059.5 of the Business and Professions Code is amended to read:4059.5.(a)Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and shall be delivered to the licensed premises and signed for and received by a pharmacist. Where a licensee is permitted to operate through a designated representative, or in the case of a reverse distributor a designated representative-reverse distributor, that individual shall sign for and receive the delivery.
(b)A dangerous drug or dangerous device transferred, sold, or delivered to a person within this state shall be transferred, sold, or delivered only to an entity licensed by the board, to a manufacturer, or to an ultimate user or the ultimate users agent.
(c)Notwithstanding subdivisions (a) and (b), deliveries to a hospital pharmacy may be made to a central receiving location within the hospital. However, the dangerous drugs or dangerous devices shall be delivered to the licensed pharmacy premises within one working day following receipt by the hospital, and the pharmacist on duty at that time shall immediately inventory the dangerous drugs or dangerous devices.
(d)Notwithstanding any other law, a dangerous drug or dangerous device may be ordered by and provided to a manufacturer, physician, dentist, podiatrist, optometrist, veterinarian, naturopathic doctor pursuant to Section 3640.7, or laboratory, or a physical therapist acting within the scope of his or her license. A person or entity receiving delivery of a dangerous drug or dangerous device, or a duly authorized representative of the person or entity, shall sign for the receipt of the dangerous drug or dangerous device.
(e)A dangerous drug or dangerous device shall not be transferred, sold, or delivered to a person outside this state, whether foreign or domestic, unless the transferor, seller, or deliverer does so in compliance with the laws of this state and of the United States and of the state or country to which the dangerous drugs or dangerous devices are to be transferred, sold, or delivered. Compliance with the laws of this state and the United States and of the state or country to which the dangerous drugs or dangerous devices are to be delivered shall include, but not be limited to, determining that the recipient of the dangerous drugs or dangerous devices is authorized by law to receive the dangerous drugs or dangerous devices.
(f)Notwithstanding subdivision (a), a pharmacy may take delivery of dangerous drugs and dangerous devices when the pharmacy is closed and no pharmacist is on duty if all of the following requirements are met:
(1)The drugs are placed in a secure storage facility in the same building as the pharmacy.
(2)Only the pharmacist-in-charge or a pharmacist designated by the pharmacist-in-charge has access to the secure storage facility after dangerous drugs or dangerous devices have been delivered.
(3)The secure storage facility has a means of indicating whether it has been entered after dangerous drugs or dangerous devices have been delivered.
(4)The pharmacy maintains written policies and procedures for the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(5)The agent delivering dangerous drugs and dangerous devices pursuant to this subdivision leaves documents indicating the name and amount of each dangerous drug or dangerous device delivered in the secure storage facility.
The pharmacy shall be responsible for the dangerous drugs and dangerous devices delivered to the secure storage facility. The pharmacy shall also be responsible for obtaining and maintaining records relating to the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(g)Notwithstanding subdivision (a), dangerous drugs and devices and controlled substances may be ordered by a remote dispensing site pharmacy licensed by the board and may be signed for and received by a registered pharmacy technician, who meets the qualifications of Section 4132, at the remote site. A controlled substance signed for by a pharmacy technician under this section shall be stored separately from existing inventory until the time the controlled substance is reviewed and countersigned by a pharmacist. Any receipt and storage of a controlled substance by a pharmacy technician pursuant to this section shall be captured on video, and that video shall be made accessible to the supervising pharmacy and maintained by the remote dispensing site pharmacy for 120 days.
SEC. 6.Section 4100 of the Business and Professions Code is amended to read:4100.Within 30 days after changing his or her address of record with the board or after changing his or her name according to law, a pharmacist, intern pharmacist, technician, designated representative, designated representative-3PL, or designated representative-reverse distributor shall notify the executive officer of the board of the change of address or change of name.
SEC. 7.Section 4160 of the Business and Professions Code is amended to read:4160.(a)A person shall not act as a wholesaler or third-party logistics provider of any dangerous drug or dangerous device unless he or she has obtained a license from the board.
(b)Upon approval by the board and the payment of the required fee, the board shall issue a license to the applicant.
(c)(1)A separate license shall be required for each place of business owned or operated by a wholesaler or third-party logistics provider. Each place of business may only be issued a single license by the board, except as provided in paragraph (2). Each license shall be renewed annually and shall not be transferable. At all times during which a place of business is open for business, at least one designated representative, in the case of a wholesaler, or designated representative-3PL in the case of a third-party logistics provider, shall be present. A wholesaler that only acts as a reverse distributor may use either a designated representative or a designated representative-reverse distributor to fulfill this requirement.
(2)A wholesaler and a third-party logistics provider under common ownership may be licensed at the same place of business provided that all of the following requirements are satisfied:
(A)The wholesaler and the third-party logistics provider each separately maintain the records required under Section 4081.
(B)Dangerous drugs and dangerous devices owned by the wholesaler are not commingled with the dangerous drugs and dangerous devices handled by the third-party logistics provider.
(C)Any individual acting as a designated representative for the wholesaler is not concurrently acting as a designated representative-3PL on behalf of the third-party logistics provider. Nothing in this subparagraph shall be construed to prohibit an individual from concurrently holding a license to act as a designated representative and to act as a designated representative-3PL.
(D)The wholesaler has its own designated representative-in-charge responsible for the operations of the wholesaler and the third-party logistics provider has its own responsible manager responsible for the operations of the third-party logistics provider. The same individual shall not concurrently serve as the responsible manager and the designated representative-in-charge for a wholesaler and a third-party logistics provider licensed at the same place of business.
(E)The third-party logistics provider does not handle the prescription drugs or prescription devices owned by a prescriber.
(F)The third-party logistics provider is not a reverse third-party logistics provider.
(G)The wholesaler is not acting as a reverse distributor.
(d)Every wholesaler shall be supervised or managed by a designated representative-in-charge. The designated representative-in-charge shall be responsible for the wholesalers compliance with state and federal laws governing wholesalers. As part of its initial application for a license, and for each renewal, each wholesaler shall, on a form designed by the board, provide identifying information and the California license number for a designated representative or pharmacist proposed to serve as the designated representative-in-charge. The proposed designated representative-in-charge shall be subject to approval by the board. The board shall not issue or renew a wholesaler license without identification of an approved designated representative-in-charge for the wholesaler. The designated representative-in-charge shall maintain an active license as a designated representative with the board at all times during which he or she is designated as the designated representative-in-charge. A wholesaler that only acts as a reverse distributor may identify and allow a designated representative-reverse distributor to perform in this capacity. That individual shall maintain an active license as a designated representative-reverse distributor.
(e)Each place of business of a third-party logistics provider shall be supervised and managed by a responsible manager. The responsible manager shall be responsible for the compliance of the place of business with state and federal laws governing third-party logistics providers and with the third-party logistics providers customer specifications, except where the customers specifications conflict with state or federal laws. As part of its initial application for a license, and for each renewal, each third-party logistics provider shall, on a form designated by the board, provide identifying information and the California license number for a designated representative-3PL proposed to serve as the responsible manager. The proposed responsible manager shall be subject to approval by the board. The board shall not issue or renew a third-party logistics provider license without identification of an approved responsible manager for the third-party logistics provider. The responsible manager shall maintain an active license as a designated representative-3PL with the board at all times during which he or she is designated as the responsible manager.
(f)A wholesaler shall notify the board in writing, on a form designed by the board, within 30 days of the date when a designated representative-in-charge ceases to act as the designated representative-in-charge, and shall on the same form propose another authorized licensee to take over as the designated representative-in-charge. The proposed replacement designated representative-in-charge shall be subject to approval by the board. If disapproved, the wholesaler shall propose another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a designated representative-in-charge is approved by the board.
(g)A third-party logistics provider shall notify the board in writing, on a form designed by the board, within 30 days of the date when a responsible manager ceases to act as the responsible manager, and shall on the same form propose another designated representative-3PL to take over as the responsible manager. The proposed replacement responsible manager shall be subject to approval by the board. If disapproved, the third-party logistics provider shall propose another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a responsible manager is approved by the board.
(h)A drug manufacturer premises licensed by the Food and Drug Administration or licensed pursuant to Section 111615 of the Health and Safety Code that only distributes dangerous drugs and dangerous devices of its own manufacture is exempt from this section and Section 4161.
(i)The board may issue a temporary license, upon conditions and for periods of time as the board determines to be in the public interest. A temporary license fee shall be required in an amount established by the board as specified in subdivision (f) of Section 4400. When needed to protect public safety, a temporary license may be issued for a period not to exceed 180 days, subject to terms and conditions that the board deems necessary. If the board determines that a temporary license was issued by mistake or denies the application for a permanent license, the temporary license shall terminate upon either personal service of the notice of termination upon the licenseholder or service by certified mail, return receipt requested, at the licenseholders address of record with the board, whichever occurs first. For purposes of retaining a temporary license, or for purposes of any disciplinary or license denial proceeding before the board, the temporary licenseholder shall not be deemed to have a vested property right or interest in the license.
SEC. 8.Section 4200.4 of the Business and Professions Code is amended to read:4200.4.An applicant who fails either the North American Pharmacist Licensure Examination or the California Practice Standards and Jurisprudence Examination for Pharmacists may not retake that examination for at least 45 days. The board may, in consultation with the Office of Professional Examination Services of the department, adopt a regulation establishing a different waiting period to retake the examination.
SEC. 9.Section 4331 of the Business and Professions Code is amended to read:4331.(a)A person not authorized under this chapter who takes charge of a wholesaler or veterinary food-animal drug retailer or who dispenses a prescription or furnishes dangerous devices, except as otherwise provided in this chapter, is guilty of a misdemeanor.
(b)A person who is not a responsible manager or a designated representative-3PL who takes charge of a third-party logistics provider or coordinates the warehousing or distribution of dangerous drugs or dangerous devices within a third-party logistics provider, except as otherwise provided in this chapter, is guilty of a misdemeanor.
(c)A person licensed as a veterinary food-animal drug retailer that fails to place in charge of that veterinary food-animal drug retailer a pharmacist or designated representative, or any person who, by himself or herself, or by any other person, permits the dispensing of prescriptions, except by a pharmacist or designated representative, or as otherwise provided in this chapter, is guilty of a misdemeanor.
(d)A person licensed as a wholesaler that fails to place in charge of that wholesaler a pharmacist or designated representative, or any person who, by himself or herself, or by any other person, permits the furnishing of dangerous drugs or dangerous devices, except by a pharmacist or designated representative, or as otherwise provided in this chapter, is guilty of a misdemeanor.
(e)A person licensed as a third-party logistics provider that fails to place in charge of a licensed place of business of the third-party logistics provider a responsible manager, or any person who, by himself or herself, or by any other person, permits the furnishing of dangerous drugs or dangerous devices, except by a facility manager, or as otherwise provided in this chapter, is guilty of a misdemeanor.
SEC. 10.Section 4400 of the Business and Professions Code, as added by Section 26 of Chapter 799 of the Statutes of 2016, is amended to read:4400.The amount of fees and penalties prescribed by this chapter, except as otherwise provided, is that fixed by the board according to the following schedule:
(a)The fee for a nongovernmental pharmacy license shall be five hundred twenty dollars ($520) and may be increased to five hundred seventy dollars ($570). The fee for the issuance of a temporary nongovernmental pharmacy permit shall be two hundred fifty dollars ($250) and may be increased to three hundred twenty-five dollars ($325).
(b)The fee for a nongovernmental pharmacy license annual renewal shall be six hundred sixty-five dollars ($665) and may be increased to nine hundred thirty dollars ($930).
(c)The fee for the pharmacist application and examination shall be two hundred sixty dollars ($260) and may be increased to two hundred eighty-five dollars ($285).
(d)The fee for regrading an examination shall be ninety dollars ($90) and may be increased to one hundred fifteen dollars ($115). If an error in grading is found and the applicant passes the examination, the regrading fee shall be refunded.
(e)The fee for a pharmacist license shall be one hundred ninety-five dollars ($195) and may be increased to two hundred fifteen dollars ($215). The fee for a pharmacist biennial renewal shall be three hundred sixty dollars ($360) and may be increased to five hundred five dollars ($505).
(f)The fee for a nongovernmental wholesaler or third-party logistics provider license and annual renewal shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(g)The fee for a hypodermic license shall be one hundred seventy dollars ($170) and may be increased to two hundred forty dollars ($240). The fee for a hypodermic license renewal shall be two hundred dollars ($200) and may be increased to two hundred eighty dollars ($280).
(h)(1)The fee for application, investigation, and issuance of a license as a designated representative pursuant to Section 4053, as a designated representative-3PL pursuant to Section 4053.1, or as a designated representative-reverse distributor pursuant to Section 4053.2 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative, designated representative-3PL, or designated representative-reverse distributor shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(i)(1)The fee for the application, investigation, and issuance of a license as a designated representative for a veterinary food-animal drug retailer pursuant to Section 4053 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative for a veterinary food-animal drug retailer shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(j)(1)The application fee for a nonresident wholesaler or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(2)For nonresident wholesalers or third-party logistics providers that have 21 or more facilities operating nationwide the application fees for the first 20 locations shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(3)The annual renewal fee for a nonresident wholesaler license or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(k)The fee for evaluation of continuing education courses for accreditation shall be set by the board at an amount not to exceed forty dollars ($40) per course hour.
(l)The fee for an intern pharmacist license shall be one hundred sixty-five dollars ($165) and may be increased to two hundred thirty dollars ($230). The fee for transfer of intern hours or verification of licensure to another state shall be twenty-five dollars ($25) and may be increased to thirty dollars ($30).
(m)The board may waive or refund the additional fee for the issuance of a license where the license is issued less than 45 days before the next regular renewal date.
(n)The fee for the reissuance of any license, or renewal thereof, that has been lost or destroyed or reissued due to a name change shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(o)The fee for the reissuance of any license, or renewal thereof, that must be reissued because of a change in the information, shall be one hundred dollars ($100) and may be increased to one hundred thirty dollars ($130).
(p)It is the intent of the Legislature that, in setting fees pursuant to this section, the board shall seek to maintain a reserve in the Pharmacy Board Contingent Fund equal to approximately one years operating expenditures.
(q)The fee for any applicant for a nongovernmental clinic license shall be five hundred twenty dollars ($520) for each license and may be increased to five hundred seventy dollars ($570). The annual fee for renewal of the license shall be three hundred twenty-five dollars ($325) for each license and may be increased to three hundred sixty dollars ($360).
(r)The fee for the issuance of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195). The fee for renewal of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195).
(s)The fee for a veterinary food-animal drug retailer license shall be four hundred thirty-five dollars ($435) and may be increased to six hundred ten dollars ($610). The annual renewal fee for a veterinary food-animal drug retailer license shall be three hundred thirty dollars ($330) and may be increased to four hundred sixty dollars ($460).
(t)The fee for issuance of a retired license pursuant to Section 4200.5 shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(u)The fee for issuance of a nongovernmental sterile compounding pharmacy license shall be one thousand six hundred forty-five dollars ($1,645) and may be increased to two thousand three hundred five dollars ($2,305). The fee for a temporary license shall be five hundred fifty dollars ($550) and may be increased to seven hundred fifteen dollars ($715). The annual renewal fee of the license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to one thousand eight hundred fifty-five dollars ($1,855).
(v)The fee for the issuance of a nonresident sterile compounding pharmacy license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to three thousand three hundred thirty-five dollars ($3,335). The annual renewal of the license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to three thousand one hundred eighty dollars ($3,180). In addition to paying that application fee, the nonresident sterile compounding pharmacy shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4127.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(w)The fee for the issuance of an outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. The fee for the renewal of an outsourcing facility license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to up to one thousand eight hundred fifty-five dollars ($1,855) by the board. The fee for a temporary outsourcing facility license shall be seven hundred fifteen dollars ($715).
(x)The fee for the issuance of a nonresident outsourcing facility license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to up to three thousand three hundred thirty-five dollars ($3,335) by the board. The fee for the renewal of a nonresident outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. In addition to paying that application fee, the nonresident outsourcing facility shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4129.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(y)The fee for the issuance of a centralized hospital packaging license shall be eight hundred twenty dollars ($820) and may be increased to one thousand one hundred fifty dollars ($1,150). The annual renewal of the license shall be eight hundred five dollars ($805) and may be increased to one thousand one hundred twenty-five dollars ($1,125).
(z)This section shall become operative on July 1, 2017.
SEC. 10.5.Section 4400 of the Business and Professions Code, as added by Section 26 of Chapter 799 of the Statutes of 2016, is amended to read:4400.The amount of fees and penalties prescribed by this chapter, except as otherwise provided, is that fixed by the board according to the following schedule:
(a)The fee for a nongovernmental pharmacy license shall be five hundred twenty dollars ($520) and may be increased to five hundred seventy dollars ($570). The fee for the issuance of a temporary nongovernmental pharmacy permit shall be two hundred fifty dollars ($250) and may be increased to three hundred twenty-five dollars ($325).
(b)The fee for a nongovernmental pharmacy license annual renewal shall be six hundred sixty-five dollars ($665) and may be increased to nine hundred thirty dollars ($930).
(c)The fee for the pharmacist application and examination shall be two hundred sixty dollars ($260) and may be increased to two hundred eighty-five dollars ($285).
(d)The fee for regrading an examination shall be ninety dollars ($90) and may be increased to one hundred fifteen dollars ($115). If an error in grading is found and the applicant passes the examination, the regrading fee shall be refunded.
(e)The fee for a pharmacist license shall be one hundred ninety-five dollars ($195) and may be increased to two hundred fifteen dollars ($215). The fee for a pharmacist biennial renewal shall be three hundred sixty dollars ($360) and may be increased to five hundred five dollars ($505).
(f)The fee for a nongovernmental wholesaler or third-party logistics provider license and annual renewal shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(g)The fee for a hypodermic license shall be one hundred seventy dollars ($170) and may be increased to two hundred forty dollars ($240). The fee for a hypodermic license renewal shall be two hundred dollars ($200) and may be increased to two hundred eighty dollars ($280).
(h)(1)The fee for application, investigation, and issuance of a license as a designated representative pursuant to Section 4053, as a designated representative-3PL pursuant to Section 4053.1, or as a designated representative-reverse distributor pursuant to Section 4053.2 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative, designated representative-3PL, or designated representative-reverse distributor shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(i)(1)The fee for the application, investigation, and issuance of a license as a designated representative for a veterinary food-animal drug retailer pursuant to Section 4053 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative for a veterinary food-animal drug retailer shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(j)(1)The application fee for a nonresident wholesaler or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(2)For nonresident wholesalers or third-party logistics providers that have 21 or more facilities operating nationwide the application fees for the first 20 locations shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(3)The annual renewal fee for a nonresident wholesaler license or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(k)The fee for evaluation of continuing education courses for accreditation shall be set by the board at an amount not to exceed forty dollars ($40) per course hour.
(l)The fee for an intern pharmacist license shall be one hundred sixty-five dollars ($165) and may be increased to two hundred thirty dollars ($230). The fee for transfer of intern hours or verification of licensure to another state shall be twenty-five dollars ($25) and may be increased to thirty dollars ($30).
(m)The board may waive or refund the additional fee for the issuance of a license where the license is issued less than 45 days before the next regular renewal date.
(n)The fee for the reissuance of any license, or renewal thereof, that has been lost or destroyed or reissued due to a name change shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(o)The fee for the reissuance of any license, or renewal thereof, that must be reissued because of a change in the information, shall be one hundred dollars ($100) and may be increased to one hundred thirty dollars ($130).
(p)It is the intent of the Legislature that, in setting fees pursuant to this section, the board shall seek to maintain a reserve in the Pharmacy Board Contingent Fund equal to approximately one years operating expenditures.
(q)The fee for any applicant for a nongovernmental clinic license shall be five hundred twenty dollars ($520) for each license and may be increased to five hundred seventy dollars ($570). The annual fee for renewal of the license shall be three hundred twenty-five dollars ($325) for each license and may be increased to three hundred sixty dollars ($360).
(r)The fee for the issuance of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195). The fee for renewal of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195).
(s)The fee for a veterinary food-animal drug retailer license shall be four hundred thirty-five dollars ($435) and may be increased to six hundred ten dollars ($610). The annual renewal fee for a veterinary food-animal drug retailer license shall be three hundred thirty dollars ($330) and may be increased to four hundred sixty dollars ($460).
(t)The fee for issuance of a retired license pursuant to Section 4200.5 shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(u)The fee for issuance of a nongovernmental sterile compounding pharmacy license or a hospital satellite compounding pharmacy shall be one thousand six hundred forty-five dollars ($1,645) and may be increased to two thousand three hundred five dollars ($2,305). The fee for a temporary license shall be five hundred fifty dollars ($550) and may be increased to seven hundred fifteen dollars ($715). The annual renewal fee of the license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to one thousand eight hundred fifty-five dollars ($1,855).
(v)The fee for the issuance of a nonresident sterile compounding pharmacy license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to three thousand three hundred thirty-five dollars ($3,335). The annual renewal of the license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to three thousand one hundred eighty dollars ($3,180). In addition to paying that application fee, the nonresident sterile compounding pharmacy shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4127.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(w)The fee for the issuance of an outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. The fee for the renewal of an outsourcing facility license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to up to one thousand eight hundred fifty-five dollars ($1,855) by the board. The fee for a temporary outsourcing facility license shall be seven hundred fifteen dollars ($715).
(x)The fee for the issuance of a nonresident outsourcing facility license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to up to three thousand three hundred thirty-five dollars ($3,335) by the board. The fee for the renewal of a nonresident outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. In addition to paying that application fee, the nonresident outsourcing facility shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4129.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(y)The fee for the issuance of a centralized hospital packaging license shall be eight hundred twenty dollars ($820) and may be increased to one thousand one hundred fifty dollars ($1,150). The annual renewal of the license shall be eight hundred five dollars ($805) and may be increased to one thousand one hundred twenty-five dollars ($1,125).
(z)This section shall become operative on July 1, 2017.
SEC. 11.Section 5.5 of this bill incorporates amendments to Section 4059.5 of the Business and Professions Code proposed by both this bill and Assembly Bill 401. That section shall only become operative if (1) both bills are enacted and become effective on or before January 1, 2018, (2) each bill amends Section 4059.5 of the Business and Professions Code, and (3) this bill is enacted after Assembly Bill 401, in which case Section 5 of this bill shall not become operative.
SEC. 12.Section 10.5 of this bill incorporates amendments to Section 4400 of the Business and Professions Code proposed by both this bill and Senate Bill 351. That section shall only become operative if (1) both bills are enacted and become effective on or before January 1, 2018, (2) each bill amends Section 4400 of the Business and Professions Code, and (3) this bill is enacted after Senate Bill 351, in which case Section 10 of this bill shall not become operative.
SEC. 13.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
(a)Designated representative means an individual to whom a license has been granted pursuant to Section 4053. A pharmacist fulfilling the duties of Section 4053 shall not be required to obtain a license as a designated representative.
(b)Designated representative-in-charge means a designated representative or designated representative-reverse distributor, or a pharmacist proposed by a wholesaler or veterinary food-animal drug retailer and approved by the board as the supervisor or manager responsible for ensuring the wholesalers or veterinary food-animal drug retailers compliance with all state and federal laws and regulations pertaining to practice in the applicable license category.
SEC. 2.Section 4022.6 is added to the Business and Professions Code, to read:4022.6.Designated representative-reverse distributor means an individual to whom a license has been granted pursuant to Section 4053.2, who is responsible for supervision over a licensed wholesaler that only acts as a reverse distributor. A pharmacist fulfilling the duties of Section 4053.2 shall not be required to obtain a license as a designated representative-reverse distributor.
SEC. 3.Section 4040.5 of the Business and Professions Code is amended to read:4040.5.Reverse distributor means every person who acts as an agent for pharmacies, drug wholesalers, third-party logistics providers, manufacturers, and other entities by receiving, inventorying, warehousing, and managing the disposition of outdated or nonsaleable dangerous drugs or dangerous devices.
SEC. 4.Section 4053.2 is added to the Business and Professions Code, to read:4053.2.(a)Notwithstanding Sections 4051 and 4053, the board may issue a designated representative-reverse distributor license to a qualified individual who shall provide sufficient and qualified supervision over a licensed wholesaler that only acts as a reverse distributor. The designated representative-reverse distributor shall protect the public health and safety in the handling, storage, warehousing, and destruction of outdated or nonsaleable dangerous drugs and dangerous devices.
(b)An individual who is at least 18 years of age may apply for a designated representative-reverse distributor license. In order to obtain and maintain that license, the individual shall meet all of the following requirements:
(1)He or she shall be a high school graduate or possess a general education development certificate equivalent.
(2)He or she shall meet one of the following requirements:
(A)Have a minimum of one year of paid work experience in the past three years with a licensed wholesaler, third-party logistics provider, or pharmacy performing duties related to the distribution, dispensing, or destruction of dangerous drugs or dangerous devices.
(B)Have a minimum of one year of paid work experience in the destruction of outdated or nonsaleable dangerous drugs or dangerous devices pharmaceutical waste.
(C)Meet all of the prerequisites to take the examination required for licensure as a pharmacist by the board.
(3)(A)He or she shall complete a training program approved by the board that, at a minimum, addresses each of the following subjects:
(i)Knowledge and understanding of California law and federal law relating to the distribution of dangerous drugs and dangerous devices.
(ii)Knowledge and understanding of California law and federal law relating to the distribution of controlled substances.
(iii)Knowledge and understanding of California law and federal law relating to the removal and destruction of dangerous drugs, dangerous devices, and pharmaceutical waste.
(iv)Knowledge and understanding of the United States Pharmacopoeia or federal Food and Drug Administration standards relating to the safe storage, handling, and transport of dangerous drugs and dangerous devices.
(B)The board may, by regulation, require the training program required under this paragraph to include additional material.
(C)The board shall not issue a license as a designated representative-reverse distributor until the applicant provides proof of completion of the training required by this paragraph to the board.
(c)A reverse distributor shall not operate without at least one designated representative or designated representative-reverse distributor present at each of its licensed places of business as required under Section 4160.
SEC. 5.Section 4059.5 of the Business and Professions Code is amended to read:4059.5.(a)Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and shall be delivered to the licensed premises and signed for and received by a pharmacist. Where a licensee is permitted to operate through a designated representative, or in the case of a reverse distributor a designated representative-reverse distributor, that individual shall sign for and receive the delivery.
(b)A dangerous drug or dangerous device transferred, sold, or delivered to a person within this state shall be transferred, sold, or delivered only to an entity licensed by the board, to a manufacturer, or to an ultimate user or the ultimate users agent.
(c)Notwithstanding subdivisions (a) and (b), deliveries to a hospital pharmacy may be made to a central receiving location within the hospital. However, the dangerous drugs or dangerous devices shall be delivered to the licensed pharmacy premises within one working day following receipt by the hospital, and the pharmacist on duty at that time shall immediately inventory the dangerous drugs or dangerous devices.
(d)Notwithstanding any other law, a dangerous drug or dangerous device may be ordered by and provided to a manufacturer, physician, dentist, podiatrist, optometrist, veterinarian, naturopathic doctor pursuant to Section 3640.7, or laboratory, or a physical therapist acting within the scope of his or her license. A person or entity receiving delivery of a dangerous drug or dangerous device, or a duly authorized representative of the person or entity, shall sign for the receipt of the dangerous drug or dangerous device.
(e)A dangerous drug or dangerous device shall not be transferred, sold, or delivered to a person outside this state, whether foreign or domestic, unless the transferor, seller, or deliverer does so in compliance with the laws of this state and of the United States and of the state or country to which the dangerous drugs or dangerous devices are to be transferred, sold, or delivered. Compliance with the laws of this state and the United States and of the state or country to which the dangerous drugs or dangerous devices are to be delivered shall include, but not be limited to, determining that the recipient of the dangerous drugs or dangerous devices is authorized by law to receive the dangerous drugs or dangerous devices.
(f)Notwithstanding subdivision (a), a pharmacy may take delivery of dangerous drugs and dangerous devices when the pharmacy is closed and no pharmacist is on duty if all of the following requirements are met:
(1)The drugs are placed in a secure storage facility in the same building as the pharmacy.
(2)Only the pharmacist-in-charge or a pharmacist designated by the pharmacist-in-charge has access to the secure storage facility after dangerous drugs or dangerous devices have been delivered.
(3)The secure storage facility has a means of indicating whether it has been entered after dangerous drugs or dangerous devices have been delivered.
(4)The pharmacy maintains written policies and procedures for the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(5)The agent delivering dangerous drugs and dangerous devices pursuant to this subdivision leaves documents indicating the name and amount of each dangerous drug or dangerous device delivered in the secure storage facility.
The pharmacy shall be responsible for the dangerous drugs and dangerous devices delivered to the secure storage facility. The pharmacy shall also be responsible for obtaining and maintaining records relating to the delivery of dangerous drugs and dangerous devices to a secure storage facility.
SEC. 5.5.Section 4059.5 of the Business and Professions Code is amended to read:4059.5.(a)Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and shall be delivered to the licensed premises and signed for and received by a pharmacist. Where a licensee is permitted to operate through a designated representative, the designated representative or in the case of a reverse distributor a designated representative-reverse distributor, that individual shall sign for and receive the delivery.
(b)A dangerous drug or dangerous device transferred, sold, or delivered to a person within this state shall be transferred, sold, or delivered only to an entity licensed by the board, to a manufacturer, or to an ultimate user or the ultimate users agent.
(c)Notwithstanding subdivisions (a) and (b), deliveries to a hospital pharmacy may be made to a central receiving location within the hospital. However, the dangerous drugs or dangerous devices shall be delivered to the licensed pharmacy premises within one working day following receipt by the hospital, and the pharmacist on duty at that time shall immediately inventory the dangerous drugs or dangerous devices.
(d)Notwithstanding any other provision of law, a dangerous drug or dangerous device may be ordered by and provided to a manufacturer, physician, dentist, podiatrist, optometrist, veterinarian, naturopathic doctor pursuant to Section 3640.7, or laboratory, or a physical therapist acting within the scope of his or her license. A person or entity receiving delivery of a dangerous drug or dangerous device, or a duly authorized representative of the person or entity, shall sign for the receipt of the dangerous drug or dangerous device.
(e)A dangerous drug or dangerous device shall not be transferred, sold, or delivered to a person outside this state, whether foreign or domestic, unless the transferor, seller, or deliverer does so in compliance with the laws of this state and of the United States and of the state or country to which the dangerous drugs or dangerous devices are to be transferred, sold, or delivered. Compliance with the laws of this state and the United States and of the state or country to which the dangerous drugs or dangerous devices are to be delivered shall include, but not be limited to, determining that the recipient of the dangerous drugs or dangerous devices is authorized by law to receive the dangerous drugs or dangerous devices.
(f)Notwithstanding subdivision (a), a pharmacy may take delivery of dangerous drugs and dangerous devices when the pharmacy is closed and no pharmacist is on duty if all of the following requirements are met:
(1)The drugs are placed in a secure storage facility in the same building as the pharmacy.
(2)Only the pharmacist-in-charge or a pharmacist designated by the pharmacist-in-charge has access to the secure storage facility after dangerous drugs or dangerous devices have been delivered.
(3)The secure storage facility has a means of indicating whether it has been entered after dangerous drugs or dangerous devices have been delivered.
(4)The pharmacy maintains written policies and procedures for the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(5)The agent delivering dangerous drugs and dangerous devices pursuant to this subdivision leaves documents indicating the name and amount of each dangerous drug or dangerous device delivered in the secure storage facility.
The pharmacy shall be responsible for the dangerous drugs and dangerous devices delivered to the secure storage facility. The pharmacy shall also be responsible for obtaining and maintaining records relating to the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(g)Notwithstanding subdivision (a), dangerous drugs and devices and controlled substances may be ordered by a remote dispensing site pharmacy licensed by the board and may be signed for and received by a registered pharmacy technician, who meets the qualifications of Section 4132, at the remote site. A controlled substance signed for by a pharmacy technician under this section shall be stored separately from existing inventory until the time the controlled substance is reviewed and countersigned by a pharmacist. Any receipt and storage of a controlled substance by a pharmacy technician pursuant to this section shall be captured on video, and that video shall be made accessible to the supervising pharmacy and maintained by the remote dispensing site pharmacy for 120 days.
SEC. 6.Section 4100 of the Business and Professions Code is amended to read:4100.Within 30 days after changing his or her address of record with the board or after changing his or her name according to law, a pharmacist, intern pharmacist, technician, designated representative, designated representative-3PL, or designated representative-reverse distributor shall notify the executive officer of the board of the change of address or change of name.
SEC. 7.Section 4160 of the Business and Professions Code is amended to read:4160.(a)A person shall not act as a wholesaler or third-party logistics provider of any dangerous drug or dangerous device unless he or she has obtained a license from the board.
(b)Upon approval by the board and the payment of the required fee, the board shall issue a license to the applicant.
(c)(1)A separate license shall be required for each place of business owned or operated by a wholesaler or third-party logistics provider. Each place of business may only be issued a single license by the board, except as provided in paragraph (2). Each license shall be renewed annually and shall not be transferable. At all times during which a place of business is open for business, at least one designated representative, in the case of a wholesaler, or designated representative-3PL in the case of a third-party logistics provider, shall be present. A wholesaler that only acts as a reverse distributor may use either a designated representative or a designated representative-reverse distributor to fulfill this requirement.
(2)A wholesaler and a third-party logistics provider under common ownership may be licensed at the same place of business provided that all of the following requirements are satisfied:
(A)The wholesaler and the third-party logistics provider each separately maintain the records required under Section 4081.
(B)Dangerous drugs and dangerous devices owned by the wholesaler are not commingled with the dangerous drugs and dangerous devices handled by the third-party logistics provider.
(C)Any individual acting as a designated representative for the wholesaler is not concurrently acting as a designated representative-3PL on behalf of the third-party logistics provider. Nothing in this subparagraph shall be construed to prohibit an individual from concurrently holding a license to act as a designated representative and to act as a designated representative-3PL.
(D)The wholesaler has its own designated representative-in-charge responsible for the operations of the wholesaler and the third-party logistics provider has its own responsible manager responsible for the operations of the third-party logistics provider. The same individual shall not concurrently serve as the responsible manager and the designated representative-in-charge for a wholesaler and a third-party logistics provider licensed at the same place of business.
(E)The third-party logistics provider does not handle the prescription drugs or prescription devices owned by a prescriber.
(F)The third-party logistics provider is not a reverse third-party logistics provider.
(G)The wholesaler is not acting as a reverse distributor.
(d)Every wholesaler shall be supervised or managed by a designated representative-in-charge. The designated representative-in-charge shall be responsible for the wholesalers compliance with state and federal laws governing wholesalers. As part of its initial application for a license, and for each renewal, each wholesaler shall, on a form designed by the board, provide identifying information and the California license number for a designated representative or pharmacist proposed to serve as the designated representative-in-charge. The proposed designated representative-in-charge shall be subject to approval by the board. The board shall not issue or renew a wholesaler license without identification of an approved designated representative-in-charge for the wholesaler. The designated representative-in-charge shall maintain an active license as a designated representative with the board at all times during which he or she is designated as the designated representative-in-charge. A wholesaler that only acts as a reverse distributor may identify and allow a designated representative-reverse distributor to perform in this capacity. That individual shall maintain an active license as a designated representative-reverse distributor.
(e)Each place of business of a third-party logistics provider shall be supervised and managed by a responsible manager. The responsible manager shall be responsible for the compliance of the place of business with state and federal laws governing third-party logistics providers and with the third-party logistics providers customer specifications, except where the customers specifications conflict with state or federal laws. As part of its initial application for a license, and for each renewal, each third-party logistics provider shall, on a form designated by the board, provide identifying information and the California license number for a designated representative-3PL proposed to serve as the responsible manager. The proposed responsible manager shall be subject to approval by the board. The board shall not issue or renew a third-party logistics provider license without identification of an approved responsible manager for the third-party logistics provider. The responsible manager shall maintain an active license as a designated representative-3PL with the board at all times during which he or she is designated as the responsible manager.
(f)A wholesaler shall notify the board in writing, on a form designed by the board, within 30 days of the date when a designated representative-in-charge ceases to act as the designated representative-in-charge, and shall on the same form propose another authorized licensee to take over as the designated representative-in-charge. The proposed replacement designated representative-in-charge shall be subject to approval by the board. If disapproved, the wholesaler shall propose another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a designated representative-in-charge is approved by the board.
(g)A third-party logistics provider shall notify the board in writing, on a form designed by the board, within 30 days of the date when a responsible manager ceases to act as the responsible manager, and shall on the same form propose another designated representative-3PL to take over as the responsible manager. The proposed replacement responsible manager shall be subject to approval by the board. If disapproved, the third-party logistics provider shall propose another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a responsible manager is approved by the board.
(h)A drug manufacturer premises licensed by the Food and Drug Administration or licensed pursuant to Section 111615 of the Health and Safety Code that only distributes dangerous drugs and dangerous devices of its own manufacture is exempt from this section and Section 4161.
(i)The board may issue a temporary license, upon conditions and for periods of time as the board determines to be in the public interest. A temporary license fee shall be required in an amount established by the board as specified in subdivision (f) of Section 4400. When needed to protect public safety, a temporary license may be issued for a period not to exceed 180 days, subject to terms and conditions that the board deems necessary. If the board determines that a temporary license was issued by mistake or denies the application for a permanent license, the temporary license shall terminate upon either personal service of the notice of termination upon the licenseholder or service by certified mail, return receipt requested, at the licenseholders address of record with the board, whichever occurs first. For purposes of retaining a temporary license, or for purposes of any disciplinary or license denial proceeding before the board, the temporary licenseholder shall not be deemed to have a vested property right or interest in the license.
SEC. 8.Section 4200.4 of the Business and Professions Code is amended to read:4200.4.An applicant who fails either the national examination North American Pharmacist Licensure Examination or the California Practice Standards and Jurisprudence Examination for Pharmacists may not retake the that examination for at least 90 days or for a period established by regulations adopted by the board 45 days. The board may, in consultation with the Office of Professional Examination Services of the department. department, adopt a regulation establishing a different waiting period to retake the examination.
SEC. 8. SEC. 9.Section 4331 of the Business and Professions Code is amended to read:4331.(a)A person not authorized under this chapter who takes charge of a wholesaler or veterinary food-animal drug retailer or who dispenses a prescription or furnishes dangerous devices, except as otherwise provided in this chapter, is guilty of a misdemeanor.
(b)A person who is not a responsible manager or a designated representative-3PL who takes charge of a third-party logistics provider or coordinates the warehousing or distribution of dangerous drugs or dangerous devices within a third-party logistics provider, except as otherwise provided in this chapter, is guilty of a misdemeanor.
(c)A person licensed as a veterinary food-animal drug retailer that fails to place in charge of that veterinary food-animal drug retailer a pharmacist or designated representative, or any person who, by himself or herself, or by any other person, permits the dispensing of prescriptions, except by a pharmacist or designated representative, or as otherwise provided in this chapter, is guilty of a misdemeanor.
(d)A person licensed as a wholesaler that fails to place in charge of that wholesaler a pharmacist or designated representative, or any person who, by himself or herself, or by any other person, permits the furnishing of dangerous drugs or dangerous devices, except by a pharmacist or designated representative, or as otherwise provided in this chapter, is guilty of a misdemeanor.
(e)A person licensed as a third-party logistics provider that fails to place in charge of a licensed place of business of the third-party logistics provider a responsible manager, or any person who, by himself or herself, or by any other person, permits the furnishing of dangerous drugs or dangerous devices, except by a facility manager, or as otherwise provided in this chapter, is guilty of a misdemeanor.
SEC. 9. SEC. 10.Section 4400 of the Business and Professions Code, as added by Section 26 of Chapter 799 of the Statutes of 2016, is amended to read:4400.The amount of fees and penalties prescribed by this chapter, except as otherwise provided, is that fixed by the board according to the following schedule:
(a)The fee for a nongovernmental pharmacy license shall be five hundred twenty dollars ($520) and may be increased to five hundred seventy dollars ($570). The fee for the issuance of a temporary nongovernmental pharmacy permit shall be two hundred fifty dollars ($250) and may be increased to three hundred twenty-five dollars ($325).
(b)The fee for a nongovernmental pharmacy license annual renewal shall be six hundred sixty-five dollars ($665) and may be increased to nine hundred thirty dollars ($930).
(c)The fee for the pharmacist application and examination shall be two hundred sixty dollars ($260) and may be increased to two hundred eighty-five dollars ($285).
(d)The fee for regrading an examination shall be ninety dollars ($90) and may be increased to one hundred fifteen dollars ($115). If an error in grading is found and the applicant passes the examination, the regrading fee shall be refunded.
(e)The fee for a pharmacist license shall be one hundred ninety-five dollars ($195) and may be increased to two hundred fifteen dollars ($215). The fee for a pharmacist biennial renewal shall be three hundred sixty dollars ($360) and may be increased to five hundred five dollars ($505).
(f)The fee for a nongovernmental wholesaler or third-party logistics provider license and annual renewal shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(g)The fee for a hypodermic license shall be one hundred seventy dollars ($170) and may be increased to two hundred forty dollars ($240). The fee for a hypodermic license renewal shall be two hundred dollars ($200) and may be increased to two hundred eighty dollars ($280).
(h)(1)The fee for application, investigation, and issuance of a license as a designated representative pursuant to Section 4053, as a designated representative-3PL pursuant to Section 4053.1, or as a designated representative-reverse distributor pursuant to Section 4053.2 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative, designated representative-3PL, or designated representative-reverse distributor shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(i)(1)The fee for the application, investigation, and issuance of a license as a designated representative for a veterinary food-animal drug retailer pursuant to Section 4053 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative for a veterinary food-animal drug retailer shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(j)(1)The application fee for a nonresident wholesaler or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(2)For nonresident wholesalers or third-party logistics providers that have 21 or more facilities operating nationwide the application fees for the first 20 locations shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(3)The annual renewal fee for a nonresident wholesaler license or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(k)The fee for evaluation of continuing education courses for accreditation shall be set by the board at an amount not to exceed forty dollars ($40) per course hour.
(l)The fee for an intern pharmacist license shall be one hundred sixty-five dollars ($165) and may be increased to two hundred thirty dollars ($230). The fee for transfer of intern hours or verification of licensure to another state shall be twenty-five dollars ($25) and may be increased to thirty dollars ($30).
(m)The board may waive or refund the additional fee for the issuance of a license where the license is issued less than 45 days before the next regular renewal date.
(n)The fee for the reissuance of any license, or renewal thereof, that has been lost or destroyed or reissued due to a name change shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(o)The fee for the reissuance of any license, or renewal thereof, that must be reissued because of a change in the information, shall be one hundred dollars ($100) and may be increased to one hundred thirty dollars ($130).
(p)It is the intent of the Legislature that, in setting fees pursuant to this section, the board shall seek to maintain a reserve in the Pharmacy Board Contingent Fund equal to approximately one years operating expenditures.
(q)The fee for any applicant for a nongovernmental clinic license shall be five hundred twenty dollars ($520) for each license and may be increased to five hundred seventy dollars ($570). The annual fee for renewal of the license shall be three hundred twenty-five dollars ($325) for each license and may be increased to three hundred sixty dollars ($360).
(r)The fee for the issuance of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195). The fee for renewal of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195).
(s)The fee for a veterinary food-animal drug retailer license shall be four hundred thirty-five dollars ($435) and may be increased to six hundred ten dollars ($610). The annual renewal fee for a veterinary food-animal drug retailer license shall be three hundred thirty dollars ($330) and may be increased to four hundred sixty dollars ($460).
(t)The fee for issuance of a retired license pursuant to Section 4200.5 shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(u)The fee for issuance of a nongovernmental sterile compounding pharmacy license shall be one thousand six hundred forty-five dollars ($1,645) and may be increased to two thousand three hundred five dollars ($2,305). The fee for a temporary license shall be five hundred fifty dollars ($550) and may be increased to seven hundred fifteen dollars ($715). The annual renewal fee of the license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to one thousand eight hundred fifty-five dollars ($1,855).
(v)The fee for the issuance of a nonresident sterile compounding pharmacy license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to three thousand three hundred thirty-five dollars ($3,335). The annual renewal of the license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to three thousand one hundred eighty dollars ($3,180). In addition to paying that application fee, the nonresident sterile compounding pharmacy shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4127.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(w)The fee for the issuance of an outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. The fee for the renewal of an outsourcing facility license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to up to one thousand eight hundred fifty-five dollars ($1,855) by the board. The fee for a temporary outsourcing facility license shall be seven hundred fifteen dollars ($715).
(x)The fee for the issuance of a nonresident outsourcing facility license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to up to three thousand three hundred thirty-five dollars ($3,335) by the board. The fee for the renewal of a nonresident outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. In addition to paying that application fee, the nonresident outsourcing facility shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4129.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(y)The fee for the issuance of a centralized hospital packaging license shall be eight hundred twenty dollars ($820) and may be increased to one thousand one hundred fifty dollars ($1,150). The annual renewal of the license shall be eight hundred five dollars ($805) and may be increased to one thousand one hundred twenty-five dollars ($1,125).
(z)This section shall become operative on July 1, 2017.
SEC. 10.5.Section 4400 of the Business and Professions Code, as added by Section 26 of Chapter 799 of the Statutes of 2016, is amended to read:4400.The amount of fees and penalties prescribed by this chapter, except as otherwise provided, is that fixed by the board according to the following schedule:
(a)The fee for a nongovernmental pharmacy license shall be five hundred twenty dollars ($520) and may be increased to five hundred seventy dollars ($570). The fee for the issuance of a temporary nongovernmental pharmacy permit shall be two hundred fifty dollars ($250) and may be increased to three hundred twenty-five dollars ($325).
(b)The fee for a nongovernmental pharmacy license annual renewal shall be six hundred sixty-five dollars ($665) and may be increased to nine hundred thirty dollars ($930).
(c)The fee for the pharmacist application and examination shall be two hundred sixty dollars ($260) and may be increased to two hundred eighty-five dollars ($285).
(d)The fee for regrading an examination shall be ninety dollars ($90) and may be increased to one hundred fifteen dollars ($115). If an error in grading is found and the applicant passes the examination, the regrading fee shall be refunded.
(e)The fee for a pharmacist license shall be one hundred ninety-five dollars ($195) and may be increased to two hundred fifteen dollars ($215). The fee for a pharmacist biennial renewal shall be three hundred sixty dollars ($360) and may be increased to five hundred five dollars ($505).
(f)The fee for a nongovernmental wholesaler or third-party logistics provider license and annual renewal shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(g)The fee for a hypodermic license shall be one hundred seventy dollars ($170) and may be increased to two hundred forty dollars ($240). The fee for a hypodermic license renewal shall be two hundred dollars ($200) and may be increased to two hundred eighty dollars ($280).
(h)(1)The fee for application, investigation, and issuance of a license as a designated representative pursuant to Section 4053, or as a designated representative-3PL pursuant to Section 4053.1, or as a designated representative-reverse distributor pursuant to Section 4053.2 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative representative, designated representative-3PL, or designated representative-3PL representative-reverse distributor shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(i)(1)The fee for the application, investigation, and issuance of a license as a designated representative for a veterinary food-animal drug retailer pursuant to Section 4053 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative for a veterinary food-animal drug retailer shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(j)(1)The application fee for a nonresident wholesaler or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(2)For nonresident wholesalers or third-party logistics providers that have 21 or more facilities operating nationwide the application fees for the first 20 locations shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(3)The annual renewal fee for a nonresident wholesaler license or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(k)The fee for evaluation of continuing education courses for accreditation shall be set by the board at an amount not to exceed forty dollars ($40) per course hour.
(l)The fee for an intern pharmacist license shall be one hundred sixty-five dollars ($165) and may be increased to two hundred thirty dollars ($230). The fee for transfer of intern hours or verification of licensure to another state shall be twenty-five dollars ($25) and may be increased to thirty dollars ($30).
(m)The board may waive or refund the additional fee for the issuance of a license where the license is issued less than 45 days before the next regular renewal date.
(n)The fee for the reissuance of any license, or renewal thereof, that has been lost or destroyed or reissued due to a name change shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(o)The fee for the reissuance of any license, or renewal thereof, that must be reissued because of a change in the information, shall be one hundred dollars ($100) and may be increased to one hundred thirty dollars ($130).
(p)It is the intent of the Legislature that, in setting fees pursuant to this section, the board shall seek to maintain a reserve in the Pharmacy Board Contingent Fund equal to approximately one years operating expenditures.
(q)The fee for any applicant for a nongovernmental clinic license shall be five hundred twenty dollars ($520) for each license and may be increased to five hundred seventy dollars ($570). The annual fee for renewal of the license shall be three hundred twenty-five dollars ($325) for each license and may be increased to three hundred sixty dollars ($360).
(r)The fee for the issuance of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195). The fee for renewal of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195).
(s)The fee for a veterinary food-animal drug retailer license shall be four hundred thirty-five dollars ($435) and may be increased to six hundred ten dollars ($610). The annual renewal fee for a veterinary food-animal drug retailer license shall be three hundred thirty dollars ($330) and may be increased to four hundred sixty dollars ($460).
(t)The fee for issuance of a retired license pursuant to Section 4200.5 shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(u)The fee for issuance of a nongovernmental sterile compounding pharmacy license or a hospital satellite compounding pharmacy shall be one thousand six hundred forty-five dollars ($1,645) and may be increased to two thousand three hundred five dollars ($2,305). The fee for a temporary license shall be five hundred fifty dollars ($550) and may be increased to seven hundred fifteen dollars ($715). The annual renewal fee of the license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to one thousand eight hundred fifty-five dollars ($1,855).
(v)The fee for the issuance of a nonresident sterile compounding pharmacy license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to three thousand three hundred thirty-five dollars ($3,335). The annual renewal of the license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to three thousand one hundred eighty dollars ($3,180). In addition to paying that application fee, the nonresident sterile compounding pharmacy shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4127.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(w)The fee for the issuance of an outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. The fee for the renewal of an outsourcing facility license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to up to one thousand eight hundred fifty-five dollars ($1,855) by the board. The fee for a temporary outsourcing facility license shall be seven hundred fifteen dollars ($715).
(x)The fee for the issuance of a nonresident outsourcing facility license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to up to three thousand three hundred thirty-five dollars ($3,335) by the board. The fee for the renewal of a nonresident outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. In addition to paying that application fee, the nonresident outsourcing facility shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4129.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(y)The fee for the issuance of a centralized hospital packaging license shall be eight hundred twenty dollars ($820) and may be increased to one thousand one hundred fifty dollars ($1,150). The annual renewal of the license shall be eight hundred five dollars ($805) and may be increased to one thousand one hundred twenty-five dollars ($1,125).
(z)This section shall become operative on July 1, 2017.
SEC. 11.Section 5.5 of this bill incorporates amendments to Section 4059.5 of the Business and Professions Code proposed by both this bill and Assembly Bill 401. That section shall only become operative if (1) both bills are enacted and become effective on or before January 1, 2018, (2) each bill amends Section 4059.5 of the Business and Professions Code, and (3) this bill is enacted after Assembly Bill 401, in which case Section 5 of this bill shall not become operative.
SEC. 12.Section 10.5 of this bill incorporates amendments to Section 4400 of the Business and Professions Code proposed by both this bill and Senate Bill 351. That section shall only become operative if (1) both bills are enacted and become effective on or before January 1, 2018, (2) each bill amends Section 4400 of the Business and Professions Code, and (3) this bill is enacted after Senate Bill 351, in which case Section 10 of this bill shall not become operative.
SEC. 10. SEC. 13.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
(a)Designated representative means an individual to whom a license has been granted pursuant to Section 4053. A pharmacist fulfilling the duties of Section 4053 shall not be required to obtain a license as a designated representative.
(b)Designated representative-in-charge means a designated representative or designated representative-reverse distributor, or a pharmacist proposed by a wholesaler or veterinary food-animal drug retailer and approved by the board as the supervisor or manager responsible for ensuring the wholesalers or veterinary food-animal drug retailers compliance with all state and federal laws and regulations pertaining to practice in the applicable license category.
SEC. 2.Section 4022.6 is added to the Business and Professions Code, to read:4022.6.Designated representative-reverse distributor means an individual to whom a license has been granted pursuant to Section 4053.2, who is responsible for supervision over a licensed wholesaler that only acts as a reverse distributor. A pharmacist fulfilling the duties of Section 4053.2 shall not be required to obtain a license as a designated representative-reverse distributor.
SEC. 3.Section 4040.5 of the Business and Professions Code is amended to read:4040.5.Reverse distributor means every person who acts as an agent for pharmacies, drug wholesalers, third-party logistics providers, manufacturers, and other entities by receiving, inventorying, warehousing, and managing the disposition of outdated or nonsaleable dangerous drugs or dangerous devices.
SEC. 4.Section 4053.2 is added to the Business and Professions Code, to read:4053.2.(a)Notwithstanding Sections 4051 and 4053, the board may issue a designated representative-reverse distributor license to a qualified individual who shall provide sufficient and qualified supervision over a licensed wholesaler that only acts as a reverse distributor. The designated representative-reverse distributor shall protect the public health and safety in the handling, storage, warehousing, and destruction of outdated or nonsaleable dangerous drugs and dangerous devices.
(b)An individual who is at least 18 years of age may apply for a designated representative-reverse distributor license. In order to obtain and maintain that license, the individual shall meet all of the following requirements:
(1)He or she shall be a high school graduate or possess a general education development certificate equivalent.
(2)He or she shall meet one of the following requirements:
(A)Have a minimum of one year of paid work experience in the past three years with a licensed wholesaler, third-party logistics provider, or pharmacy performing duties related to the distribution, dispensing, or destruction of dangerous drugs or dangerous devices.
(B)Have a minimum of one year of paid work experience in the destruction of outdated or nonsaleable dangerous drugs or dangerous devices pharmaceutical waste.
(C)Meet all of the prerequisites to take the examination required for licensure as a pharmacist by the board.
(3)(A)He or she shall complete a training program approved by the board that, at a minimum, addresses each of the following subjects:
(i)Knowledge and understanding of California law and federal law relating to the distribution of dangerous drugs and dangerous devices.
(ii)Knowledge and understanding of California law and federal law relating to the distribution of controlled substances.
(iii)Knowledge and understanding of California law and federal law relating to the removal and destruction of dangerous drugs, dangerous devices, and pharmaceutical waste.
(iv)Knowledge and understanding of the United States Pharmacopoeia or federal Food and Drug Administration standards relating to the safe storage, handling, and transport of dangerous drugs and dangerous devices.
(B)The board may, by regulation, require the training program required under this paragraph to include additional material.
(C)The board shall not issue a license as a designated representative-reverse distributor until the applicant provides proof of completion of the training required by this paragraph to the board.
(c)A reverse distributor shall not operate without at least one designated representative or designated representative-reverse distributor present at each of its licensed places of business as required under Section 4160.
SEC. 5.Section 4059.5 of the Business and Professions Code is amended to read:4059.5.(a)Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and shall be delivered to the licensed premises and signed for and received by a pharmacist. Where a licensee is permitted to operate through a designated representative, or in the case of a reverse distributor a designated representative-reverse distributor, that individual shall sign for and receive the delivery.
(b)A dangerous drug or dangerous device transferred, sold, or delivered to a person within this state shall be transferred, sold, or delivered only to an entity licensed by the board, to a manufacturer, or to an ultimate user or the ultimate users agent.
(c)Notwithstanding subdivisions (a) and (b), deliveries to a hospital pharmacy may be made to a central receiving location within the hospital. However, the dangerous drugs or dangerous devices shall be delivered to the licensed pharmacy premises within one working day following receipt by the hospital, and the pharmacist on duty at that time shall immediately inventory the dangerous drugs or dangerous devices.
(d)Notwithstanding any other law, a dangerous drug or dangerous device may be ordered by and provided to a manufacturer, physician, dentist, podiatrist, optometrist, veterinarian, naturopathic doctor pursuant to Section 3640.7, or laboratory, or a physical therapist acting within the scope of his or her license. A person or entity receiving delivery of a dangerous drug or dangerous device, or a duly authorized representative of the person or entity, shall sign for the receipt of the dangerous drug or dangerous device.
(e)A dangerous drug or dangerous device shall not be transferred, sold, or delivered to a person outside this state, whether foreign or domestic, unless the transferor, seller, or deliverer does so in compliance with the laws of this state and of the United States and of the state or country to which the dangerous drugs or dangerous devices are to be transferred, sold, or delivered. Compliance with the laws of this state and the United States and of the state or country to which the dangerous drugs or dangerous devices are to be delivered shall include, but not be limited to, determining that the recipient of the dangerous drugs or dangerous devices is authorized by law to receive the dangerous drugs or dangerous devices.
(f)Notwithstanding subdivision (a), a pharmacy may take delivery of dangerous drugs and dangerous devices when the pharmacy is closed and no pharmacist is on duty if all of the following requirements are met:
(1)The drugs are placed in a secure storage facility in the same building as the pharmacy.
(2)Only the pharmacist-in-charge or a pharmacist designated by the pharmacist-in-charge has access to the secure storage facility after dangerous drugs or dangerous devices have been delivered.
(3)The secure storage facility has a means of indicating whether it has been entered after dangerous drugs or dangerous devices have been delivered.
(4)The pharmacy maintains written policies and procedures for the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(5)The agent delivering dangerous drugs and dangerous devices pursuant to this subdivision leaves documents indicating the name and amount of each dangerous drug or dangerous device delivered in the secure storage facility.
The pharmacy shall be responsible for the dangerous drugs and dangerous devices delivered to the secure storage facility. The pharmacy shall also be responsible for obtaining and maintaining records relating to the delivery of dangerous drugs and dangerous devices to a secure storage facility.
SEC. 6.Section 4100 of the Business and Professions Code is amended to read:4100.Within 30 days after changing his or her address of record with the board or after changing his or her name according to law, a pharmacist, intern pharmacist, technician, designated representative, designated representative-3PL, or designated representative-reverse distributor shall notify the executive officer of the board of the change of address or change of name.
SEC. 7.Section 4160 of the Business and Professions Code is amended to read:4160.(a)A person shall not act as a wholesaler or third-party logistics provider of any dangerous drug or dangerous device unless he or she has obtained a license from the board.
(b)Upon approval by the board and the payment of the required fee, the board shall issue a license to the applicant.
(c)(1)A separate license shall be required for each place of business owned or operated by a wholesaler or third-party logistics provider. Each place of business may only be issued a single license by the board, except as provided in paragraph (2). Each license shall be renewed annually and shall not be transferable. At all times during which a place of business is open for business, at least one designated representative, in the case of a wholesaler, or designated representative-3PL in the case of a third-party logistics provider, shall be present. A wholesaler that only acts as a reverse distributor may use either a designated representative or a designated representative-reverse distributor to fulfill this requirement.
(2)A wholesaler and a third-party logistics provider under common ownership may be licensed at the same place of business provided that all of the following requirements are satisfied:
(A)The wholesaler and the third-party logistics provider each separately maintain the records required under Section 4081.
(B)Dangerous drugs and dangerous devices owned by the wholesaler are not commingled with the dangerous drugs and dangerous devices handled by the third-party logistics provider.
(C)Any individual acting as a designated representative for the wholesaler is not concurrently acting as a designated representative-3PL on behalf of the third-party logistics provider. Nothing in this subparagraph shall be construed to prohibit an individual from concurrently holding a license to act as a designated representative and to act as a designated representative-3PL.
(D)The wholesaler has its own designated representative-in-charge responsible for the operations of the wholesaler and the third-party logistics provider has its own responsible manager responsible for the operations of the third-party logistics provider. The same individual shall not concurrently serve as the responsible manager and the designated representative-in-charge for a wholesaler and a third-party logistics provider licensed at the same place of business.
(E)The third-party logistics provider does not handle the prescription drugs or prescription devices owned by a prescriber.
(F)The third-party logistics provider is not a reverse third-party logistics provider.
(G)The wholesaler is not acting as a reverse distributor.
(d)Every wholesaler shall be supervised or managed by a designated representative-in-charge. The designated representative-in-charge shall be responsible for the wholesalers compliance with state and federal laws governing wholesalers. As part of its initial application for a license, and for each renewal, each wholesaler shall, on a form designed by the board, provide identifying information and the California license number for a designated representative or pharmacist proposed to serve as the designated representative-in-charge. The proposed designated representative-in-charge shall be subject to approval by the board. The board shall not issue or renew a wholesaler license without identification of an approved designated representative-in-charge for the wholesaler. The designated representative-in-charge shall maintain an active license as a designated representative with the board at all times during which he or she is designated as the designated representative-in-charge. A wholesaler that only acts as a reverse distributor may identify and allow a designated representative-reverse distributor to perform in this capacity. That individual shall maintain an active license as a designated representative-reverse distributor.
(e)Each place of business of a third-party logistics provider shall be supervised and managed by a responsible manager. The responsible manager shall be responsible for the compliance of the place of business with state and federal laws governing third-party logistics providers and with the third-party logistics providers customer specifications, except where the customers specifications conflict with state or federal laws. As part of its initial application for a license, and for each renewal, each third-party logistics provider shall, on a form designated by the board, provide identifying information and the California license number for a designated representative-3PL proposed to serve as the responsible manager. The proposed responsible manager shall be subject to approval by the board. The board shall not issue or renew a third-party logistics provider license without identification of an approved responsible manager for the third-party logistics provider. The responsible manager shall maintain an active license as a designated representative-3PL with the board at all times during which he or she is designated as the responsible manager.
(f)A wholesaler shall notify the board in writing, on a form designed by the board, within 30 days of the date when a designated representative-in-charge ceases to act as the designated representative-in-charge, and shall on the same form propose another authorized licensee to take over as the designated representative-in-charge. The proposed replacement designated representative-in-charge shall be subject to approval by the board. If disapproved, the wholesaler shall propose another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a designated representative-in-charge is approved by the board.
(g)A third-party logistics provider shall notify the board in writing, on a form designed by the board, within 30 days of the date when a responsible manager ceases to act as the responsible manager, and shall on the same form propose another designated representative-3PL to take over as the responsible manager. The proposed replacement responsible manager shall be subject to approval by the board. If disapproved, the third-party logistics provider shall propose another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a responsible manager is approved by the board.
(h)A drug manufacturer premises licensed by the Food and Drug Administration or licensed pursuant to Section 111615 of the Health and Safety Code that only distributes dangerous drugs and dangerous devices of its own manufacture is exempt from this section and Section 4161.
(i)The board may issue a temporary license, upon conditions and for periods of time as the board determines to be in the public interest. A temporary license fee shall be required in an amount established by the board as specified in subdivision (f) of Section 4400. When needed to protect public safety, a temporary license may be issued for a period not to exceed 180 days, subject to terms and conditions that the board deems necessary. If the board determines that a temporary license was issued by mistake or denies the application for a permanent license, the temporary license shall terminate upon either personal service of the notice of termination upon the licenseholder or service by certified mail, return receipt requested, at the licenseholders address of record with the board, whichever occurs first. For purposes of retaining a temporary license, or for purposes of any disciplinary or license denial proceeding before the board, the temporary licenseholder shall not be deemed to have a vested property right or interest in the license.
SEC. 8.Section 4331 of the Business and Professions Code is amended to read:4331.(a)A person not authorized under this chapter who takes charge of a wholesaler or veterinary food-animal drug retailer or who dispenses a prescription or furnishes dangerous devices, except as otherwise provided in this chapter, is guilty of a misdemeanor.
(b)A person who is not a responsible manager or a designated representative-3PL who takes charge of a third-party logistics provider or coordinates the warehousing or distribution of dangerous drugs or dangerous devices within a third-party logistics provider, except as otherwise provided in this chapter, is guilty of a misdemeanor.
(c)A person licensed as a veterinary food-animal drug retailer that fails to place in charge of that veterinary food-animal drug retailer a pharmacist or designated representative, or any person who, by himself or herself, or by any other person, permits the dispensing of prescriptions, except by a pharmacist or designated representative, or as otherwise provided in this chapter, is guilty of a misdemeanor.
(d)A person licensed as a wholesaler that fails to place in charge of that wholesaler a pharmacist or designated representative, or any person who, by himself or herself, or by any other person, permits the furnishing of dangerous drugs or dangerous devices, except by a pharmacist or designated representative, or as otherwise provided in this chapter, is guilty of a misdemeanor.
(e)A person licensed as a third-party logistics provider that fails to place in charge of a licensed place of business of the third-party logistics provider a responsible manager, or any person who, by himself or herself, or by any other person, permits the furnishing of dangerous drugs or dangerous devices, except by a facility manager, or as otherwise provided in this chapter, is guilty of a misdemeanor.
SEC. 9.Section 4400 of the Business and Professions Code, as added by Section 26 of Chapter 799 of the Statutes of 2016, is amended to read:4400.The amount of fees and penalties prescribed by this chapter, except as otherwise provided, is that fixed by the board according to the following schedule:
(a)The fee for a nongovernmental pharmacy license shall be five hundred twenty dollars ($520) and may be increased to five hundred seventy dollars ($570). The fee for the issuance of a temporary nongovernmental pharmacy permit shall be two hundred fifty dollars ($250) and may be increased to three hundred twenty-five dollars ($325).
(b)The fee for a nongovernmental pharmacy license annual renewal shall be six hundred sixty-five dollars ($665) and may be increased to nine hundred thirty dollars ($930).
(c)The fee for the pharmacist application and examination shall be two hundred sixty dollars ($260) and may be increased to two hundred eighty-five dollars ($285).
(d)The fee for regrading an examination shall be ninety dollars ($90) and may be increased to one hundred fifteen dollars ($115). If an error in grading is found and the applicant passes the examination, the regrading fee shall be refunded.
(e)The fee for a pharmacist license shall be one hundred ninety-five dollars ($195) and may be increased to two hundred fifteen dollars ($215). The fee for a pharmacist biennial renewal shall be three hundred sixty dollars ($360) and may be increased to five hundred five dollars ($505).
(f)The fee for a nongovernmental wholesaler or third-party logistics provider license and annual renewal shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(g)The fee for a hypodermic license shall be one hundred seventy dollars ($170) and may be increased to two hundred forty dollars ($240). The fee for a hypodermic license renewal shall be two hundred dollars ($200) and may be increased to two hundred eighty dollars ($280).
(h)(1)The fee for application, investigation, and issuance of a license as a designated representative pursuant to Section 4053, as a designated representative-3PL pursuant to Section 4053.1, or as a designated representative-reverse distributor pursuant to Section 4053.2 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative, designated representative-3PL, or designated representative-reverse distributor shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(i)(1)The fee for the application, investigation, and issuance of a license as a designated representative for a veterinary food-animal drug retailer pursuant to Section 4053 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative for a veterinary food-animal drug retailer shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(j)(1)The application fee for a nonresident wholesaler or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(2)For nonresident wholesalers or third-party logistics providers that have 21 or more facilities operating nationwide the application fees for the first 20 locations shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(3)The annual renewal fee for a nonresident wholesaler license or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(k)The fee for evaluation of continuing education courses for accreditation shall be set by the board at an amount not to exceed forty dollars ($40) per course hour.
(l)The fee for an intern pharmacist license shall be one hundred sixty-five dollars ($165) and may be increased to two hundred thirty dollars ($230). The fee for transfer of intern hours or verification of licensure to another state shall be twenty-five dollars ($25) and may be increased to thirty dollars ($30).
(m)The board may waive or refund the additional fee for the issuance of a license where the license is issued less than 45 days before the next regular renewal date.
(n)The fee for the reissuance of any license, or renewal thereof, that has been lost or destroyed or reissued due to a name change shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(o)The fee for the reissuance of any license, or renewal thereof, that must be reissued because of a change in the information, shall be one hundred dollars ($100) and may be increased to one hundred thirty dollars ($130).
(p)It is the intent of the Legislature that, in setting fees pursuant to this section, the board shall seek to maintain a reserve in the Pharmacy Board Contingent Fund equal to approximately one years operating expenditures.
(q)The fee for any applicant for a nongovernmental clinic license shall be five hundred twenty dollars ($520) for each license and may be increased to five hundred seventy dollars ($570). The annual fee for renewal of the license shall be three hundred twenty-five dollars ($325) for each license and may be increased to three hundred sixty dollars ($360).
(r)The fee for the issuance of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195). The fee for renewal of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195).
(s)The fee for a veterinary food-animal drug retailer license shall be four hundred thirty-five dollars ($435) and may be increased to six hundred ten dollars ($610). The annual renewal fee for a veterinary food-animal drug retailer license shall be three hundred thirty dollars ($330) and may be increased to four hundred sixty dollars ($460).
(t)The fee for issuance of a retired license pursuant to Section 4200.5 shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(u)The fee for issuance of a nongovernmental sterile compounding pharmacy license shall be one thousand six hundred forty-five dollars ($1,645) and may be increased to two thousand three hundred five dollars ($2,305). The fee for a temporary license shall be five hundred fifty dollars ($550) and may be increased to seven hundred fifteen dollars ($715). The annual renewal fee of the license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to one thousand eight hundred fifty-five dollars ($1,855).
(v)The fee for the issuance of a nonresident sterile compounding pharmacy license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to three thousand three hundred thirty-five dollars ($3,335). The annual renewal of the license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to three thousand one hundred eighty dollars ($3,180). In addition to paying that application fee, the nonresident sterile compounding pharmacy shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4127.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(w)The fee for the issuance of an outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. The fee for the renewal of an outsourcing facility license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to up to one thousand eight hundred fifty-five dollars ($1,855) by the board. The fee for a temporary outsourcing facility license shall be seven hundred fifteen dollars ($715).
(x)The fee for the issuance of a nonresident outsourcing facility license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to up to three thousand three hundred thirty-five dollars ($3,335) by the board. The fee for the renewal of a nonresident outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. In addition to paying that application fee, the nonresident outsourcing facility shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4129.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(y)The fee for the issuance of a centralized hospital packaging license shall be eight hundred twenty dollars ($820) and may be increased to one thousand one hundred fifty dollars ($1,150). The annual renewal of the license shall be eight hundred five dollars ($805) and may be increased to one thousand one hundred twenty-five dollars ($1,125).
(z)This section shall become operative on July 1, 2017.
SEC. 10.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
(a)Designated representative means an individual to whom a license has been granted pursuant to Section 4053. A pharmacist fulfilling the duties of Section 4053 shall not be required to obtain a license as a designated representative.
(b)Designated representative-in-charge means a designated representative or designated representative-reverse distributor, or a pharmacist proposed by a wholesaler or veterinary food-animal drug retailer and approved by the board as the supervisor or manager responsible for ensuring the wholesalers or veterinary food-animal drug retailers compliance with all state and federal laws and regulations pertaining to practice in the applicable license category.
SEC. 2.Section 4022.6 is added to the Business and Professions Code, to read:4022.6.Designated representative-reverse distributor means an individual to whom a license has been granted pursuant to Section 4053.2, who is responsible for supervision over a licensed wholesaler that only acts as a reverse distributor. A pharmacist fulfilling the duties of Section 4053.2 shall not be required to obtain a license as a designated representative-reverse distributor.
SEC. 3.Section 4040.5 of the Business and Professions Code is amended to read:4040.5.Reverse distributor means every person who acts as an agent for pharmacies, drug wholesalers, third-party logistics providers, manufacturers, and other entities by receiving, inventorying, warehousing, and managing the disposition of outdated or nonsaleable dangerous drugs. drugs or dangerous devices.
SEC. 4.Section 4053.2 is added to the Business and Professions Code, to read:4053.2.(a)Notwithstanding Sections 4051 and 4053, the board may issue a designated representative-reverse distributor license to a qualified individual who shall provide sufficient and qualified supervision over a licensed wholesaler that only acts as a reverse distributor. The designated representative-reverse distributor shall protect the public health and safety in the handling, storage, warehousing, and destruction of outdated or nonsaleable dangerous drugs and dangerous devices.
(b)An individual who is at least 18 years of age may apply for a designated representative-reverse distributor license. In order to obtain and maintain that license, the individual shall meet all of the following requirements:
(1)He or she shall be a high school graduate or possess a general education development certificate equivalent.
(2)He or she shall meet one of the following requirements:
(A)Have a minimum of one year of paid work experience in the past three years with a licensed wholesaler, third-party logistics provider, or pharmacy performing duties related to the distribution, dispensing, or destruction of dangerous drugs or dangerous devices.
(B)Have a minimum of one year of paid work experience in the destruction of outdated or nonsaleable dangerous drugs or dangerous devices pharmaceutical waste.
(C)Meet all of the prerequisites to take the examination required for licensure as a pharmacist by the board.
(3)(A)He or she shall complete a training program approved by the board that, at a minimum, addresses each of the following subjects:
(i)Knowledge and understanding of California law and federal law relating to the distribution of dangerous drugs and dangerous devices.
(ii)Knowledge and understanding of California law and federal law relating to the distribution of controlled substances.
(iii)Knowledge and understanding of California law and federal law relating to the removal and destruction of dangerous drugs, dangerous devices, and pharmaceutical waste.
(iv)Knowledge and understanding of the United States Pharmacopoeia or federal Food and Drug Administration standards relating to the safe storage, handling, and transport of dangerous drugs and dangerous devices.
(B)The board may, by regulation, require the training program required under this paragraph to include additional material.
(C)The board shall not issue a license as a designated representative-reverse distributor until the applicant provides proof of completion of the training required by this paragraph to the board.
(c)A reverse distributor shall not operate without at least one designated representative or designated representative-reverse distributor present at each of its licensed places of business as required under Section 4160.
SEC. 5.Section 4059.5 of the Business and Professions Code is amended to read:4059.5.(a)Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and shall be delivered to the licensed premises and signed for and received by a pharmacist. Where a licensee is permitted to operate through a designated representative, or in the case of a reverse distributor a designated representative representative-reverse distributor, that individual shall sign for and receive the delivery.
(b)A dangerous drug or dangerous device transferred, sold, or delivered to a person within this state shall be transferred, sold, or delivered only to an entity licensed by the board, to a manufacturer, or to an ultimate user or the ultimate users agent.
(c)Notwithstanding subdivisions (a) and (b), deliveries to a hospital pharmacy may be made to a central receiving location within the hospital. However, the dangerous drugs or dangerous devices shall be delivered to the licensed pharmacy premises within one working day following receipt by the hospital, and the pharmacist on duty at that time shall immediately inventory the dangerous drugs or dangerous devices.
(d)Notwithstanding any other provision of law, a dangerous drug or dangerous device may be ordered by and provided to a manufacturer, physician, dentist, podiatrist, optometrist, veterinarian, naturopathic doctor pursuant to Section 3640.7, or laboratory, or a physical therapist acting within the scope of his or her license. A person or entity receiving delivery of a dangerous drug or dangerous device, or a duly authorized representative of the person or entity, shall sign for the receipt of the dangerous drug or dangerous device.
(e)A dangerous drug or dangerous device shall not be transferred, sold, or delivered to a person outside this state, whether foreign or domestic, unless the transferor, seller, or deliverer does so in compliance with the laws of this state and of the United States and of the state or country to which the dangerous drugs or dangerous devices are to be transferred, sold, or delivered. Compliance with the laws of this state and the United States and of the state or country to which the dangerous drugs or dangerous devices are to be delivered shall include, but not be limited to, determining that the recipient of the dangerous drugs or dangerous devices is authorized by law to receive the dangerous drugs or dangerous devices.
(f)Notwithstanding subdivision (a), a pharmacy may take delivery of dangerous drugs and dangerous devices when the pharmacy is closed and no pharmacist is on duty if all of the following requirements are met:
(1)The drugs are placed in a secure storage facility in the same building as the pharmacy.
(2)Only the pharmacist-in-charge or a pharmacist designated by the pharmacist-in-charge has access to the secure storage facility after dangerous drugs or dangerous devices have been delivered.
(3)The secure storage facility has a means of indicating whether it has been entered after dangerous drugs or dangerous devices have been delivered.
(4)The pharmacy maintains written policies and procedures for the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(5)The agent delivering dangerous drugs and dangerous devices pursuant to this subdivision leaves documents indicating the name and amount of each dangerous drug or dangerous device delivered in the secure storage facility.
The pharmacy shall be responsible for the dangerous drugs and dangerous devices delivered to the secure storage facility. The pharmacy shall also be responsible for obtaining and maintaining records relating to the delivery of dangerous drugs and dangerous devices to a secure storage facility.
SEC. 6.Section 4100 of the Business and Professions Code is amended to read:4100.(a)Within 30 days after changing his or her address of record with the board or after changing his or her name according to law, a pharmacist, intern pharmacist, technician, designated representative, designated representative-3PL, or designated representative representative-reverse distributor shall notify the executive officer of the board of the change of address or change of name.
(b)This section shall become operative on January 1, 2006.SEC. 7.Section 4160 of the Business and Professions Code is amended to read:4160.(a)A person shall not act as a wholesaler or third-party logistics provider of any dangerous drug or dangerous device unless he or she has obtained a license from the board.
(b)Upon approval by the board and the payment of the required fee, the board shall issue a license to the applicant.
(c)(1)A separate license shall be required for each place of business owned or operated by a wholesaler or third-party logistics provider. Each place of business may only be issued a single license by the board, except as provided in paragraph (2). Each license shall be renewed annually and shall not be transferable. At all times during which a place of business is open for business, at least one designated representative, in the case of a wholesaler, or designated representative-3PL in the case of a third-party logistics provider, shall be present. A wholesaler that only acts as a reverse distributor may use either a designated representative or a designated representative-reverse distributor to fulfill this requirement.
(2)A wholesaler and a third-party logistics provider under common ownership may be licensed at the same place of business provided that all of the following requirements are satisfied:
(A)The wholesaler and the third-party logistics provider each separately maintain the records required under Section 4081.
(B)Dangerous drugs and dangerous devices owned by the wholesaler are not commingled with the dangerous drugs and dangerous devices handled by the third-party logistics provider.
(C)Any individual acting as a designated representative for the wholesaler is not concurrently acting as a designated representative-3PL on behalf of the third-party logistics provider. Nothing in this subparagraph shall be construed to prohibit an individual from concurrently holding a license to act as a designated representative and to act as a designated representative-3PL.
(D)The wholesaler has its own designated representative-in-charge responsible for the operations of the wholesaler and the third-party logistics provider has its own responsible manager responsible for the operations of the third-party logistics provider. The same individual shall not concurrently serve as the responsible manager and the designated representative-in-charge for a wholesaler and a third-party logistics provider licensed at the same place of business.
(E)The third-party logistics provider does not handle the prescription drugs or prescription devices owned by a prescriber.
(F)The third-party logistics provider is not a reverse third-party logistics provider.
(G)The wholesaler is not acting as a reverse distributor.
(d)Every wholesaler shall be supervised or managed by a designated representative-in-charge. The designated representative-in-charge shall be responsible for the wholesalers compliance with state and federal laws governing wholesalers. As part of its initial application for a license, and for each renewal, each wholesaler shall, on a form designed by the board, provide identifying information and the California license number for a designated representative or pharmacist proposed to serve as the designated representative-in-charge. The proposed designated representative-in-charge shall be subject to approval by the board. The board shall not issue or renew a wholesaler license without identification of an approved designated representative-in-charge for the wholesaler. The designated representative-in-charge shall maintain an active license as a designated representative with the board at all times during which he or she is designated as the designated representative-in-charge. A wholesaler that only acts as a reverse distributor may identify and allow a designated representative-reverse distributor to perform in this capacity. That individual shall maintain an active license as a designated representative-reverse distributor.
(e)Each place of business of a third-party logistics provider shall be supervised and managed by a responsible manager. The responsible manager shall be responsible for the compliance of the place of business with state and federal laws governing third-party logistics providers and with the third-party logistics providers customer specifications, except where the customers specifications conflict with state or federal laws. As part of its initial application for a license, and for each renewal, each third-party logistics provider shall, on a form designated by the board, provide identifying information and the California license number for a designated representative-3PL proposed to serve as the responsible manager. The proposed responsible manager shall be subject to approval by the board. The board shall not issue or renew a third-party logistics provider license without identification of an approved responsible manager for the third-party logistics provider. The responsible manager shall maintain an active license as a designated representative-3PL with the board at all times during which he or she is designated as the responsible manager.
(f)A wholesaler shall notify the board in writing, on a form designed by the board, within 30 days of the date when a designated representative-in-charge ceases to act as the designated representative-in-charge, and shall on the same form propose another designated representative or pharmacist authorized licensee to take over as the designated representative-in-charge. The proposed replacement designated representative-in-charge shall be subject to approval by the board. If disapproved, the wholesaler shall propose another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a designated representative-in-charge is approved by the board.
(g)A third-party logistics provider shall notify the board in writing, on a form designed by the board, within 30 days of the date when a responsible manager ceases to act as the responsible manager, and shall on the same form propose another designated representative-3PL to take over as the responsible manager. The proposed replacement responsible manager shall be subject to approval by the board. If disapproved, the third-party logistics provider shall propose another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a responsible manager is approved by the board.
(h)A drug manufacturer premises licensed by the Food and Drug Administration or licensed pursuant to Section 111615 of the Health and Safety Code that only distributes dangerous drugs and dangerous devices of its own manufacture is exempt from this section and Section 4161.
(i)The board may issue a temporary license, upon conditions and for periods of time as the board determines to be in the public interest. A temporary license fee shall be required in an amount established by the board as specified in subdivision (f) of Section 4400. When needed to protect public safety, a temporary license may be issued for a period not to exceed 180 days, subject to terms and conditions that the board deems necessary. If the board determines that a temporary license was issued by mistake or denies the application for a permanent license, the temporary license shall terminate upon either personal service of the notice of termination upon the licenseholder or service by certified mail, return receipt requested, at the licenseholders address of record with the board, whichever occurs first. Neither for For purposes of retaining a temporary license, nor or for purposes of any disciplinary or license denial proceeding before the board, shall the temporary licenseholder shall not be deemed to have a vested property right or interest in the license.
SEC. 8.Section 4331 of the Business and Professions Code is amended to read:4331.(a)A person who is not a pharmacist, a designated representative-in-charge, or a designated representative and authorized under this chapter who takes charge of a wholesaler or veterinary food-animal drug retailer or who dispenses a prescription or furnishes dangerous devices, except as otherwise provided in this chapter, is guilty of a misdemeanor.
(b)A person who is not a responsible manager or a designated representative-3PL who takes charge of a third-party logistics provider or coordinates the warehousing or distribution of dangerous drugs or dangerous devices within a third-party logistics provider, except as otherwise provided in this chapter, is guilty of a misdemeanor.
(c)A person licensed as a veterinary food-animal drug retailer that fails to place in charge of that veterinary food-animal drug retailer a pharmacist or designated representative, or any person who, by himself or herself, or by any other person, permits the dispensing of prescriptions, except by a pharmacist or designated representative, or as otherwise provided in this chapter, is guilty of a misdemeanor.
(d)A person licensed as a wholesaler that fails to place in charge of that wholesaler a pharmacist or designated representative, or any person who, by himself or herself, or by any other person, permits the furnishing of dangerous drugs or dangerous devices, except by a pharmacist or designated representative, or as otherwise provided in this chapter, is guilty of a misdemeanor.
(e)A person licensed as a third-party logistics provider that fails to place in charge of a licensed place of business of the third-party logistics provider a responsible manager, or any person who, by himself or herself, or by any other person, permits the furnishing of dangerous drugs or dangerous devices, except by a facility manager, or as otherwise provided in this chapter, is guilty of a misdemeanor.
SEC. 9.Section 4400 of the Business and Professions Code, as added by Section 26 of Chapter 799 of the Statutes of 2016, is amended to read:4400.The amount of fees and penalties prescribed by this chapter, except as otherwise provided, is that fixed by the board according to the following schedule:
(a)The fee for a nongovernmental pharmacy license shall be five hundred twenty dollars ($520) and may be increased to five hundred seventy dollars ($570). The fee for the issuance of a temporary nongovernmental pharmacy permit shall be two hundred fifty dollars ($250) and may be increased to three hundred twenty-five dollars ($325).
(b)The fee for a nongovernmental pharmacy license annual renewal shall be six hundred sixty-five dollars ($665) and may be increased to nine hundred thirty dollars ($930).
(c)The fee for the pharmacist application and examination shall be two hundred sixty dollars ($260) and may be increased to two hundred eighty-five dollars ($285).
(d)The fee for regrading an examination shall be ninety dollars ($90) and may be increased to one hundred fifteen dollars ($115). If an error in grading is found and the applicant passes the examination, the regrading fee shall be refunded.
(e)The fee for a pharmacist license shall be one hundred ninety-five dollars ($195) and may be increased to two hundred fifteen dollars ($215). The fee for a pharmacist biennial renewal shall be three hundred sixty dollars ($360) and may be increased to five hundred five dollars ($505).
(f)The fee for a nongovernmental wholesaler or third-party logistics provider license and annual renewal shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(g)The fee for a hypodermic license shall be one hundred seventy dollars ($170) and may be increased to two hundred forty dollars ($240). The fee for a hypodermic license renewal shall be two hundred dollars ($200) and may be increased to two hundred eighty dollars ($280).
(h)(1)The fee for application, investigation, and issuance of a license as a designated representative pursuant to Section 4053, or as a designated representative-3PL pursuant to Section 4053.1, or as a designated representative-reverse distributor pursuant to Section 4053.2 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative representative, designated representative-3PL, or designated representative-3PL representative-reverse distributor shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(i)(1)The fee for the application, investigation, and issuance of a license as a designated representative for a veterinary food-animal drug retailer pursuant to Section 4053 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative for a veterinary food-animal drug retailer shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(j)(1)The application fee for a nonresident wholesaler or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(2)For nonresident wholesalers or third-party logistics providers that have 21 or more facilities operating nationwide the application fees for the first 20 locations shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(3)The annual renewal fee for a nonresident wholesaler license or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(k)The fee for evaluation of continuing education courses for accreditation shall be set by the board at an amount not to exceed forty dollars ($40) per course hour.
(l)The fee for an intern pharmacist license shall be one hundred sixty-five dollars ($165) and may be increased to two hundred thirty dollars ($230). The fee for transfer of intern hours or verification of licensure to another state shall be twenty-five dollars ($25) and may be increased to thirty dollars ($30).
(m)The board may waive or refund the additional fee for the issuance of a license where the license is issued less than 45 days before the next regular renewal date.
(n)The fee for the reissuance of any license, or renewal thereof, that has been lost or destroyed or reissued due to a name change shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(o)The fee for the reissuance of any license, or renewal thereof, that must be reissued because of a change in the information, shall be one hundred dollars ($100) and may be increased to one hundred thirty dollars ($130).
(p)It is the intent of the Legislature that, in setting fees pursuant to this section, the board shall seek to maintain a reserve in the Pharmacy Board Contingent Fund equal to approximately one years operating expenditures.
(q)The fee for any applicant for a nongovernmental clinic license shall be five hundred twenty dollars ($520) for each license and may be increased to five hundred seventy dollars ($570). The annual fee for renewal of the license shall be three hundred twenty-five dollars ($325) for each license and may be increased to three hundred sixty dollars ($360).
(r)The fee for the issuance of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195). The fee for renewal of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195).
(s)The fee for a veterinary food-animal drug retailer license shall be four hundred thirty-five dollars ($435) and may be increased to six hundred ten dollars ($610). The annual renewal fee for a veterinary food-animal drug retailer license shall be three hundred thirty dollars ($330) and may be increased to four hundred sixty dollars ($460).
(t)The fee for issuance of a retired license pursuant to Section 4200.5 shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(u)The fee for issuance of a nongovernmental sterile compounding pharmacy license shall be one thousand six hundred forty-five dollars ($1,645) and may be increased to two thousand three hundred five dollars ($2,305). The fee for a temporary license shall be five hundred fifty dollars ($550) and may be increased to seven hundred fifteen dollars ($715). The annual renewal fee of the license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to one thousand eight hundred fifty-five dollars ($1,855).
(v)The fee for the issuance of a nonresident sterile compounding pharmacy license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to three thousand three hundred thirty-five dollars ($3,335). The annual renewal of the license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to three thousand one hundred eighty dollars ($3,180). In addition to paying that application fee, the nonresident sterile compounding pharmacy shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4127.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(w)The fee for the issuance of an outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. The fee for the renewal of an outsourcing facility license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to up to one thousand eight hundred fifty-five dollars ($1,855) by the board. The fee for a temporary outsourcing facility license shall be seven hundred fifteen dollars ($715).
(x)The fee for the issuance of a nonresident outsourcing facility license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to up to three thousand three hundred thirty-five dollars ($3,335) by the board. The fee for the renewal of a nonresident outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. In addition to paying that application fee, the nonresident outsourcing facility shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4129.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(y)The fee for the issuance of a centralized hospital packaging license shall be eight hundred twenty dollars ($820) and may be increased to one thousand one hundred fifty dollars ($1,150). The annual renewal of the license shall be eight hundred five dollars ($805) and may be increased to one thousand one hundred twenty-five dollars ($1,125).
(z)This section shall become operative on July 1, 2017.
SEC. 10.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
SECTION 1.Section 25207.3 of the Health and Safety Code is amended to read:25207.3.A participating county shall conduct a survey to identify all eligible participants in the county, within 180 days after the county elects to implement this article, to assess the amount, kind, and condition of the banned, unregistered, or outdated agricultural waste that will be collected by the program. The survey shall include, but not be limited to, an evaluation of the banned, unregistered, or outdated agricultural waste to determine if it is securely contained, if it requires a removal or remedial action, whether the contents of the waste are known, and whether it is clearly labeled.A participating county shall conduct a survey to identify all eligible participants in the county, within 180 days after the county elects to implement this article, to assess the amount, kind, and conditions condition of the banned, unregistered, or outdated agricultural waste which that will be collected by the program. The survey shall include, but not be limited to, an evaluation of the banned, unregistered, or outdated agricultural waste to determine if it is securely contained, if it requires a removal or remedial action, whether the contents of the wastes waste are known, and whether it is clearly labeled.
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Date
|
Status
|
|---|---|
| Oct 8, 2017 | Chaptered by Secretary of State. Chapter 598, Statutes of 2017. |
| Oct 8, 2017 | Approved by the Governor. |
| Sep 21, 2017 | Enrolled and presented to the Governor at 5:30 p.m. |
| Sep 14, 2017 | Assembly amendments concurred in. (Ayes 39. Noes 0.) Ordered to engrossing and enrolling. |
| Sep 12, 2017 | Ordered to special consent calendar. |
| Sep 11, 2017 | In Senate. Concurrence in Assembly amendments pending. |
| Sep 11, 2017 | Read third time. Passed. Ordered to the Senate. |
| Sep 7, 2017 | Ordered to third reading. |
| Aug 31, 2017 | Action rescinded whereby the bill was read a third time, passed, and ordered transmitted to the Senate. |
| Aug 28, 2017 | In Assembly. Held at Desk. |
| Aug 28, 2017 | Withdrawn from engrossing and enrolling. |
| Aug 24, 2017 | In Senate. Ordered to engrossing and enrolling. |
| Aug 24, 2017 | Read third time. Passed. Ordered to the Senate. |
| Jul 20, 2017 | Read second time. Ordered to consent calendar. |
| Jul 19, 2017 | From committee: Do pass. Ordered to consent calendar. (Ayes 16. Noes 0.) (July 19). |
| Jun 20, 2017 | From committee: Do pass and re-refer to Com. on APPR. (Ayes 15. Noes 0.) (June 20). Re-referred to Com. on APPR. |
| May 26, 2017 | Referred to Com. on B. & P. |
| May 4, 2017 | In Assembly. Read first time. Held at Desk. |
| May 4, 2017 | Read third time. Passed. (Ayes 39. Noes 0. Page 955.) Ordered to the Assembly. |
| May 2, 2017 | Read second time. Ordered to third reading. |
| May 1, 2017 | From committee: Do pass. (Ayes 7. Noes 0. Page 913.) (May 1). |
| Apr 21, 2017 | Set for hearing May 1. |
| Apr 18, 2017 | From committee: Do pass and re-refer to Com. on APPR. (Ayes 9. Noes 0. Page 727.) (April 17). Re-referred to Com. on APPR. |
| Apr 7, 2017 | Set for hearing April 17. |
| Apr 5, 2017 | Re-referred to Com. on B., P. & E.D. |
| Mar 28, 2017 | From committee with author's amendments. Read second time and amended. Re-referred to Com. on RLS. |
| Mar 9, 2017 | Referred to Com. on RLS. |
| Feb 21, 2017 | From printer. May be acted upon on or after March 23. |
| Feb 17, 2017 | Introduced. Read first time. To Com. on RLS. for assignment. To print. |
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Date
|
Description
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Location
|
Votes
|
|
|---|---|---|---|---|
| Sep 14, 2017 | Special Consent Calendar SB752 | Senate Floor |
Passed |
|
| Sep 11, 2017 | SB 752 Stone Senate Third Reading By WALDRON | Assembly Floor |
Passed |
|
| Aug 24, 2017 | SB 752 Stone Consent Calendar Second Day Regular Session | Assembly Floor |
Passed |
|
| Jul 19, 2017 | Do pass. To Consent Calendar. | Assembly Standing Committee on Appropriations |
Passed |
|
| Jun 20, 2017 | Do pass and be re-referred to the Committee on [Appropriations] | Assembly Standing Committee on Business and Professions |
Passed |
|
| May 4, 2017 | Senate 3rd Reading SB752 Stone | Senate Floor |
Passed |
|
| May 1, 2017 | Do pass | Senate Standing Committee on Appropriations |
Passed |
|
| Apr 17, 2017 | Do pass, but first be re-referred to the Committee on [Appropriations] | Senate Standing Committee on Business, Professions and Economic Development |
Passed |
This list shows positions taken on this bill by organizations on the date displayed, which is linked to the original source.
Positions by individuals are not included.
|
Organization
|
Position
|
Date
|
|---|---|---|
| Board of Pharmacy | * Support | Apr 17, 2017 |
| California Board of Pharmacy | ** Support | Sep 12, 2017 |
| California State Board of Pharmacy | * Indeterminate | Jun 20, 2017 |
| Medical Waste Services | ** Support | Sep 12, 2017 |
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | SB |
UNFINISHED BUSINESS
Bill No: SB 752
:
SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 9-0, 4/17/17
AYES: Hill, Bates, Dodd, Galgiani, Glazer, Hernandez, Newman, Pan, Wilk
SENATE APPROPRIATIONS COMMITTEE: 7-0, 5/1/17
AYES: Lara, Bates, Beall, Bradford, Hill, Nielsen, Wiener
SENATE FLOOR: 39-0, 5/4/17
AYES: Allen, Anderson, Atkins, Bates, Beall, Berryhill, Bradford, Cannella, De León, Dodd, Fuller, Gaines, Galgiani, Glazer, Hernandez, Hill, Hueso, Jackson, Lara, Leyva, McGuire, Mendoza, Mitchell, Monning, Moorlach, Morrell, Newman, Nguyen, Nielsen, Pan, Portantino, Roth, Skinner, Stern, Stone, Vidak, Wieckowski, Wiener, Wilk
NO VOTE RECORDED: Hertzberg
ASSEMBLY FLOOR: 76-0, 9/11/17 - See last page for vote
SOURCE: California Board of Pharmacy
DIGEST:
This bill establishes a “designated representative-reverse distributor” license issued by the Board of Pharmacy and revises waiting periods to retake professional pharmacy licensing exams.
Assembly Amendments
make chaptering amendments, make changes to the timing for retaking the North American Pharmacist Licensure Examination, and establish a waiting period for retaking the California Practice Standards and Jurisprudence Examination for Pharmacists.
Existing law:
- Establishes the Board of Pharmacy (BOP) within the Department of Consumer Affairs to administer and enforce the Pharmacy Law. (Business and Professions Code Section § 4001)
- Defines a “designated representative” as an individual to whom a license has been granted, as specified, but that a pharmacist fulfilling the duties of a designated representative is not required to obtain a license as a designated representative. (BPC § 4022.5 (a))
- Defines a “designated representative-in-charge” as a designated representative or a pharmacist proposed by a wholesaler or veterinary food-animal drug retailer and approved by the BOP as the supervisor or manager responsible for ensuring compliance with all state and federal laws and regulations pertaining to practice in the applicable license category. (BPC § 4022.5 (b))
- Establishes requirements for licensure as a designated representative and specifies that a designated representative provide sufficient and qualified supervision in a wholesaler or veterinary food-animal drug retailer and shall protect the public health and safety in the handling, storage, and shipment of dangerous drugs and dangerous devices in the wholesaler or veterinary food-animal drug retailer. (BPC § 4053)
- Defines a “reverse distributor” as every person who acts as an agent for pharmacies, drug wholesalers, third-party logistics providers (3PL), manufacturers, and other entities by receiving, inventorying, warehousing, and managing the disposition of outdated or nonsaleable dangerous drugs.
(BPC § 4040.5)
This bill:
- Establishes a designated representative-reverse distributor (DRRD) license.
- Defines a DRRD as a licensed individual who is responsible for supervision over a licensed wholesaler that only acts as a reverse distributor. A pharmacist fulfilling these duties shall not be required to obtain a license as a DRRD.
- Adds a DRRD to the definition of a designated representative in charge.
- Adds the receiving, inventorying, warehousing, and managing the disposition of outdated or nonsaleable dangerous devices to the duties of a reverse distributor.
- Authorizes the BOP to issue a DRRD to a qualified individual who shall provide sufficient and qualified supervision over a licensed wholesaler that only acts as a reverse distributor. The designated representative-reverse distributor shall protect the public health and safety in the handling, storage, warehousing, and destruction of outdated or nonsaleable dangerous drugs and dangerous devices.
- An applicant for a DRRD license must:
- Be at least 18 years of age;
- Be a high school graduate or possess a general education development certificate equivalent;
- Meet one of the following requirements:
- Have a minimum of one year of paid work experience in the past three years with a licensed wholesaler, 3PL, or pharmacy performing duties related to the distribution, dispensing, or destruction of dangerous drugs or dangerous devices;
- Have a minimum of one year of paid work experience in the destruction of outdated or nonsaleable dangerous drugs or dangerous devices pharmaceutical waste; or,
- Meet all of the prerequisites to take the examination required for licensure as a pharmacist by the BOP.
- Complete a training program approved by the BOP that, at a minimum, addresses each of the following subjects:
- Knowledge and understanding of California law and federal law relating to the distribution of dangerous drugs and dangerous devices;
- Knowledge and understanding of California law and federal law relating to the distribution of controlled substances;
- Knowledge and understanding of California law and federal law relating to the removal and destruction of dangerous drugs, dangerous devices, and pharmaceutical waste;
- Knowledge and understanding of the United States Pharmacopoeia or federal Food and Drug Administration standards relating to the safe storage, handling, and transport of dangerous drugs and dangerous devices.
- Authorizes the BOP to require the training program to include additional material.
- Requires the applicant to show proof of completion to the BOP of the training required prior to obtaining a license as a DRRD.
- Prohibits a reverse distributor from operating without at least one designated representative or DRRD present at each of its licensed places of business, as specified.
- Adds a DRRD to the list of individuals who may sign for and receive delivery of dangerous drugs or dangerous devices at a licensed premise, as specified.
- Requires a designated 3PL and DRRD to notify the BOP Executive Officer within 30 days after changing his or her address of record or after legally changing his or her name.
- Authorizes a wholesaler who only acts as a reverse distributor to use either a designated representative or a DRRD to satisfy the requirement that the wholesaler have at least one designated representative present at all times it is open for business.
- Authorizes a wholesaler who only acts as a reverse distributor to identify and allow a DRRD to act in the capacity of a designated representative in charge.
- Establishes a fee range for application and annual renewal of a DRRD license to be between $150-$210 and $215-$300, respectively.
- Reduces the time from 90 to 45 days required for an applicant to wait before retaking the North American Pharmacist Licensure Examination.
- Requires an applicant who fails the California Practice Standards and Jurisprudence Examination for Pharmacists to wait 45 days before retaking it.
- Authorizes the BOP, in consultation with the Office of Professional Examination Services, to adopt a regulation establishing a different waiting period to retake the examinations specified.
- Makes technical changes.
Background
The BOP currently recognizes entities who handle the disposition of outdated or non-saleable dangerous drugs to other licensees as a “reverse distributor.” Current law also considers someone who sells for resale, or negotiates for distribution, or takes possession of, any drug or device, a wholesaler. Therefore, a reverse distributor is also a wholesaler.
A wholesaler is required to have a designated representative onsite in order to conduct business, and one of these individuals must be deemed “in charge” who is responsible for the wholesaler’s compliance with state and federal laws governing wholesalers.
This bill creates a specialized designated representative license for an entity whose only business is handling dangerous drugs and devices for destruction.
According to the Author’s office, “When assessing the current requirements for a designated representative, it seems that some of the requirements may not be necessary when the individual is working for a business whose sole business model is handling dangerous drugs and pharmaceutical waste for destruction.
“As background, the BOP learned of this issue from a company that received approval to dispose of pharmaceutical waste using a high heat technology that is more environmentally friendly that incineration. However, as part of the company’s approval process from various state and federal regulators, the company was advised [by the DEA] that it must also be licensed by the board as a reverse distributor. The company expressed challenges with finding individuals that meet the licensing requirements as a designated representative and questioned if the requirements are appropriate for this type of business model.”
This bill also aligns BOP’s waiting period to retake the national and California exams with that of the National Association of Boards of Pharmacy, which reduced its waiting period from 90 to 45 days for the national exam.
FISCAL EFFECT: Appropriation: Fiscal Com.: Local:
According to the Assembly Appropriations Committee, minor and absorbable costs and potential minor additional revenues to the Board of Pharmacy to approve training curricula and issue additional licenses to a small licensee population.
California Board of Pharmacy (source)
Medical Waste Services
None received
ARGUMENTS IN SUPPORT: The BOP writes, “Reverse distributors process or manage the disposition of outdated or unsaleable drugs. We believe that such a business model warrants the board’s efforts to create a licensing category that more clearly reflects the minimum qualifications someone must meet to perform the duties of disposal and destruction of medications from the supply chain. This measure is consistent with this goal.”
ASSEMBLY FLOOR: 76-0, 9/11/17
AYES: Acosta, Aguiar-Curry, Travis Allen, Arambula, Baker, Berman, Bigelow, Bloom, Bocanegra, Bonta, Burke, Caballero, Calderon, Cervantes, Chau, Chávez, Chen, Chiu, Choi, Chu, Cooley, Cooper, Cunningham, Dababneh, Dahle, Daly, Eggman, Flora, Fong, Frazier, Friedman, Gallagher, Cristina Garcia, Eduardo Garcia, Gipson, Gonzalez Fletcher, Gray, Grayson, Holden, Irwin, Jones-Sawyer, Kalra, Kiley, Lackey, Levine, Limón, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Muratsuchi, Nazarian, Obernolte, O'Donnell, Patterson, Quirk, Quirk-Silva, Reyes, Ridley-Thomas, Rodriguez, Rubio, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Voepel, Waldron, Weber, Wood, Rendon
NO VOTE RECORDED: Brough, Gloria, Harper
9/12/17 9:31:44
**** END ****
SENATE THIRD READING
STR Bill Id:SB 752
Author:(Stone)
As Amended Ver:September 7, 2017
Majority vote
SENATE VOTE: 39-0
Committee | Votes | Ayes | Noes |
Business & Professions | 15-0 | Low, Brough, Arambula, Baker, Bloom, Chiu, Cunningham, Dahle, Eggman, Gipson, Grayson, Holden, Irwin, Berman, Ting |
|
Appropriations | 16-0 | Gonzalez Fletcher, Bigelow, Bloom, Bocanegra, Bonta, Brough, Quirk, Chau, Eggman, Fong, Friedman, Eduardo Garcia, McCarty, Muratsuchi, Obernolte, Reyes |
|
SUMMARY: Authorizes the Board of Pharmacy (Board) to issue a designated representative-reverse distributer license to a person qualified to supervise a licensed wholesaler. Specifically, this bill:
- Adds "designated representative-reverse distributor" to the definition of designated representative and specifies that a "designated representative-reverse distributor" means an individual to whom a license has been granted, who is responsible for supervision over a licensed wholesaler that only acts as a reverse distributor.
- Specifies that a licensed pharmacist shall not be required to obtain a license as a designated representative-reverse distributor.
- Adds dangerous devices to the list of items that a specified entity can receive, inventory, warehouse, and manage the disposition of.
- Permits the Board to issue a designated representative-reverse distributor license to a qualified individual who shall provide sufficient and qualified supervision over a licensed wholesaler that only acts as a reverse distributor. The designated representative-reverse distributor shall protect the public health and safety in the handling, storage, warehousing, and destruction of outdated or nonsaleable dangerous drugs and dangerous devices.
- States that an individual who is at least 18 years of age may apply for a designated representative-reverse distributor license. In order to obtain and maintain that license, the individual shall meet all of the following requirements:
- He or she shall be a high school graduate or possess a general education development certificate equivalent.
- He or she shall meet one of the following requirements:
- Have a minimum of one year of paid work experience in the past three years with a licensed wholesaler, third-party logistics provider, or pharmacy performing duties related to the distribution, dispensing, or destruction of dangerous drugs or dangerous devices.
- Have a minimum of one year of paid work experience in the destruction of outdated or nonsaleable dangerous drugs or dangerous devices pharmaceutical waste.
- Meet all of the prerequisites to take the examination required for licensure as a pharmacist by the board.
- He or she shall complete a training program approved by the board that, at a minimum, addresses each of the following subjects:
- Knowledge and understanding of California law and federal law relating to the distribution of dangerous drugs and dangerous devices.
- Knowledge and understanding of California law and federal law relating to the distribution of controlled substances.
- Knowledge and understanding of California law and federal law relating to the removal and destruction of dangerous drugs, dangerous devices, and pharmaceutical waste.
- Knowledge and understanding of the United States Pharmacopoeia or federal Food and Drug Administration standards relating to the safe storage, handling, and transport of dangerous drugs and dangerous devices.
Permits the Board to promulgate regulations to require the training program to include additional material.
States that the Board shall not issue a license as a designated representative-reverse distributor until the applicant provides proof of completion of the training to the Board.
Requires a reverse distributor to have at least one designated representative or designated representative-reverse distributor present at each of its licensed places of business.
Adds designated representative-reverse distributor as an individual who may sign for and receive deliveries of dangerous drugs or devices.
Specifies that each license shall be renewed annually and shall not be transferable. At all times during which a place of business is open for business, at least one designated representative, in the case of a wholesaler, or designated representative-3PL in the case of a third-party logistics provider, shall be present. A wholesaler that only acts as a reverse distributor may use either a designated representative or a designated representative-reverse distributor to fulfill this requirement.
States that the fee for application, investigation, and issuance of a license as a designated representative, or as a designated representative-3PL, or as a designated representative-reverse distributor shall be $150 and may be increased to $210.
States that the fee for the annual renewal of a license as a designated representative, designated representative-3PL, or designated representative-reverse distributor shall be $215 and may be increased to $300.
Permit a remote dispensing site pharmacy to order dangerous drugs and devices and allow a registered pharmacy technician to sign for the drugs.
Require controlled substances to be stored separately from existing inventory until the controlled substances are reviewed and countersigned by a pharmacist.
Require any receipt and storage of a controlled substance by a pharmacy technician to be captured on video, and the video must be made accessible to the supervising pharmacy and maintained by the remote dispensing site pharmacy for 120 days.
Specify that an applicant who fails either the North American Pharmacist Licensure Examination or the California Practice Standards and Jurisprudence Examination for Pharmacists may not retake the examination for at least 45 days, and permit the Board to adopt a regulation establishing a different waiting period to retake the examination.
Add designated representative-reverse distributor as an entity subject to application fees, investigation and issuance of a license from the Board.
Specify that a hospital satellite compounding pharmacy is subject to the same fees that a sterile compounding pharmacy license is subject to.
FISCAL EFFECT: According to the Assembly Appropriations Committee, minor and absorbable costs and potential minor additional revenues to the Board of Pharmacy to approve training curricula and issue additional licenses to a small licensee population.
COMMENTS: This bill is sponsored by the Board of Pharmacy. According to the author, "Current law allows for reverse distributors. They are in charge of receiving, inventorying, warehousing, and managing the disposition of outdated or non-saleable dangerous drugs. However, it seems that some of the requirements for receiving a license for reverse distributor may not be necessary when the individual is working for a business whose sole business model is handling dangerous drugs and pharmaceutical waste for destruction. SB 752 establishes, through the creation of a new licensing category, a designated representative license for individuals working in a reverse distributor."
Analysis Prepared by: Le Ondra Clark Harvey, Ph.D. / B. & P. / (916) 319-3301 FN: 0002035
SENATE THIRD READING
STR Bill Id:SB 752
Author:(Stone)
As Amended Ver:March 28, 2017
Majority vote
SENATE VOTE: 39-0
Committee | Votes | Ayes | Noes |
Business & Professions | 15-0 | Low, Brough, Arambula, Baker, Bloom, Chiu, Cunningham, Dahle, Eggman, Gipson, Grayson, Holden, Irwin, Berman, Ting | |
Appropriations | 16-0 | Gonzalez Fletcher, Bigelow, Bloom, Bocanegra, Bonta, Brough, Quirk, Chau, Eggman, Fong, Friedman, Eduardo Garcia, McCarty, Muratsuchi, Obernolte, Reyes |
SUMMARY: Authorizes the Board of Pharmacy (Board) to issue a designated representative-reverse distributer license to a person qualified to supervise a licensed wholesaler. Specifically, this bill:
- Adds "designated representative-reverse distributor" to the definition of designated representative and specifies that a "designated representative-reverse distributor" means an individual to whom a license has been granted, who is responsible for supervision over a licensed wholesaler that only acts as a reverse distributor.
- Specifies that a licensed pharmacist shall not be required to obtain a license as a designated representative-reverse distributor.
- Adds dangerous devices to the list of items that a specified entity can receive, inventory, warehouse, and manage the disposition of.
- Permits the Board to issue a designated representative-reverse distributor license to a qualified individual who shall provide sufficient and qualified supervision over a licensed wholesaler that only acts as a reverse distributor. The designated representative-reverse distributor shall protect the public health and safety in the handling, storage, warehousing, and destruction of outdated or nonsaleable dangerous drugs and dangerous devices.
- States that an individual who is at least 18 years of age may apply for a designated representative-reverse distributor license. In order to obtain and maintain that license, the individual shall meet all of the following requirements:
- He or she shall be a high school graduate or possess a general education development certificate equivalent.
- He or she shall meet one of the following requirements:
- Have a minimum of one year of paid work experience in the past three years with a licensed wholesaler, third-party logistics provider, or pharmacy performing duties related to the distribution, dispensing, or destruction of dangerous drugs or dangerous devices.
- Have a minimum of one year of paid work experience in the destruction of outdated or nonsaleable dangerous drugs or dangerous devices pharmaceutical waste.
- Meet all of the prerequisites to take the examination required for licensure as a pharmacist by the board.
- He or she shall complete a training program approved by the board that, at a minimum, addresses each of the following subjects:
- Knowledge and understanding of California law and federal law relating to the distribution of dangerous drugs and dangerous devices.
- Knowledge and understanding of California law and federal law relating to the distribution of controlled substances.
- Knowledge and understanding of California law and federal law relating to the removal and destruction of dangerous drugs, dangerous devices, and pharmaceutical waste.
- Knowledge and understanding of the United States Pharmacopoeia or federal Food and Drug Administration standards relating to the safe storage, handling, and transport of dangerous drugs and dangerous devices.
- Permits the Board to promulgate regulations to require the training program to include additional material.
- States that the Board shall not issue a license as a designated representative-reverse distributor until the applicant provides proof of completion of the training to the Board.
- Requires a reverse distributor to have at least one designated representative or designated representative-reverse distributor present at each of its licensed places of business.
- Adds designated representative-reverse distributor as an individual who may sign for and receive deliveries of dangerous drugs or devices.
- Specifies that each license shall be renewed annually and shall not be transferable. At all times during which a place of business is open for business, at least one designated representative, in the case of a wholesaler, or designated representative-3PL in the case of a third-party logistics provider, shall be present. A wholesaler that only acts as a reverse distributor may use either a designated representative or a designated representative-reverse distributor to fulfill this requirement.
- States that the fee for application, investigation, and issuance of a license as a designated representative, or as a designated representative-3PL, or as a designated representative-reverse distributor shall be $150 and may be increased to $210.
- States that the fee for the annual renewal of a license as a designated representative, designated representative-3PL, or designated representative-reverse distributor shall be $215 and may be increased to $300.
FISCAL EFFECT: According to the Assembly Committee on Appropriations, minor and absorbable costs and potential minor additional revenues to the Board of Pharmacy to approve training curricula and issue additional licenses to a small licensee population.
COMMENTS: This bill is sponsored by the Board of Pharmacy. According to the author, "Current law allows for reverse distributors. They are in charge of receiving, inventorying, warehousing, and managing the disposition of outdated or non-saleable dangerous drugs. However, it seems that some of the requirements for receiving a license for reverse distributor may not be necessary when the individual is working for a business whose sole business model is handling dangerous drugs and pharmaceutical waste for destruction. SB 752 establishes, through the creation of a new licensing category, a designated representative license for individuals working in a reverse distributor."
Analysis Prepared by: Robert Sumner / B. & P. / (916) 319-3301 FN: 0001591
Date of Hearing: July 19, 2017
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Lorena Gonzalez Fletcher, Chair
SBPCA Bill Id:SB 752
Author:(Stone) – As Amended Ver:March 28, 2017
Policy Committee: | Business and Professions | Vote: | 15 - 0 |
Urgency: No State Mandated Local Program: Yes Reimbursable: No
SUMMARY:
This bill establishes a "designated representative-reverse distributor" license type for individuals who are in charge of maintaining a reverse distributor's compliance with state and federal laws, and adds the new license type into the current fee schedule for similar licenses.
FISCAL EFFECT:
- Minor and absorbable costs, and potential minor additional revenues, to the Board of Pharmacy to approve training curricula and issue additional licenses. The Board does not anticipate significant licensee population (Pharmacy Board Contingent Fund).
- Expected information technology impact of approximately $5,000 (Pharmacy Board Contingent Fund).
COMMENTS:
- Purpose. This bill establishes a license type for a "designated representative-reverse distributor," for purposes of offering a licensure option with less stringent requirements to reflect the needs of reverse distributors. This bill is sponsored by the Board of Pharmacy and has no opposition.
- Background. Drugs are distributed through a closed system with tight controls. Current law requires licensure of reverse distributors—entities involved in receiving, inventorying, warehousing, and managing the disposition of outdated or non-saleable dangerous drugs. Each reverse distributor must have a designated representative or pharmacist in charge of maintaining legal compliance. The Board found current licensure requirements for a designated representative, which also apply to other types of drug wholesalers, may be unnecessarily stringent in the case of reverse distributors. This bill gives such entities a less stringent option for designated representative licensure.
Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081
Date of Hearing:
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Evan Low, Chair
SBPCA Bill Id:
Author:() – As Ver:
SENATE VOTE:
SUBJECT:
SUMMARY: Authorizes the Board of Pharmacy (Board) to issue a designated representative-reverse distributer license to a person qualified to supervise a licensed wholesaler, as specified; requires designated representative-reverse distributors and designated representative- third party logistics providers (3PLs), to notify the executive officer of the Board of a change of name or address; and authorizes persons who act as agents for pharmacies or other entities by receiving, inventorying, warehousing, and managing the disposition of outdated or non-saleable dangerous devices to be recognized as reverse distributors.
EXISTING LAW:
- Establishes the Board within the Department of Consumer Affairs to administer and enforce the Pharmacy Law. (Business and Professions Code Section (BPC) § 4001)
- Defines a “designated representative” as an individual to whom a license has been granted, as specified, but that a pharmacist fulfilling the duties of a designated representative is not required to obtain a license as a designated representative. (BPC § 4022.5 (a))
- Defines a “designated representative-in-charge” as a designated representative or a pharmacist proposed by a wholesaler or veterinary food-animal drug retailer and approved by the Board as the supervisor or manager responsible for ensuring compliance with all state and federal laws and regulations pertaining to practice in the applicable license category. (BPC § 4022.5 (b))
- Establishes requirements for licensure as a designated representative and specifies that a designated representative provide sufficient and qualified supervision in a wholesaler or veterinary food-animal drug retailer and shall protect the public health and safety in the handling, storage, and shipment of dangerous drugs and dangerous devices in the wholesaler or veterinary food-animal drug retailer.
(BPC § 4053) - Defines a “reverse distributor” as every person who acts as an agent for pharmacies, drug wholesalers, 3PLs, manufacturers, and other entities by receiving, inventorying, warehousing, and managing the disposition of outdated or non-saleable dangerous drugs. (BPC § 4040.5)
THIS BILL:
- Adds “designated representative-reverse distributor” to the definition of designated representative and specifies that a “designated representative-reverse distributor” means an individual to whom a license has been granted, who is responsible for supervision over a licensed wholesaler that only acts as a reverse distributor.
- Specifies that a licensed pharmacist shall not be required to obtain a license as a designated representative-reverse distributor.
- Adds dangerous devices to the list of items that a specified entity can receive, inventory, warehouse, and manage the disposition of.
- Permits the Board to issue a designated representative-reverse distributor license to a qualified individual who shall provide sufficient and qualified supervision over a licensed wholesaler that only acts as a reverse distributor. The designated representative-reverse distributor shall protect the public health and safety in the handling, storage, warehousing, and destruction of outdated or nonsaleable dangerous drugs and dangerous devices.
- States that an individual who is at least 18 years of age may apply for a designated representative-reverse distributor license. In order to obtain and maintain that license, the individual shall meet all of the following requirements:
- He or she shall be a high school graduate or possess a general education development certificate equivalent.
- He or she shall meet one of the following requirements:
- Have a minimum of one year of paid work experience in the past three years with a licensed wholesaler, third-party logistics provider, or pharmacy performing duties related to the distribution, dispensing, or destruction of dangerous drugs or dangerous devices.
- Have a minimum of one year of paid work experience in the destruction of outdated or nonsaleable dangerous drugs or dangerous devices pharmaceutical waste.
- Meet all of the prerequisites to take the examination required for licensure as a pharmacist by the board.
- He or she shall complete a training program approved by the board that, at a minimum, addresses each of the following subjects:
- Knowledge and understanding of California law and federal law relating to the distribution of dangerous drugs and dangerous devices.
- Knowledge and understanding of California law and federal law relating to the distribution of controlled substances.
- Knowledge and understanding of California law and federal law relating to the removal and destruction of dangerous drugs, dangerous devices, and pharmaceutical waste.
- Knowledge and understanding of the United States Pharmacopoeia or federal Food and Drug Administration standards relating to the safe storage, handling, and transport of dangerous drugs and dangerous devices.
- Permits the Board to promulgate regulations to require the training program to include additional material.
- States that the Board shall not issue a license as a designated representative-reverse distributor until the applicant provides proof of completion of the training to the Board.
- Requires a reverse distributor to have at least one designated representative or designated representative-reverse distributor present at each of its licensed places of business.
- Adds designated representative-reverse distributor as an individual who may sign for and receive deliveries of dangerous drugs or devices.
- Specifies that each license shall be renewed annually and shall not be transferable. At all times during which a place of business is open for business, at least one designated representative, in the case of a wholesaler, or designated representative-3PL in the case of a third-party logistics provider, shall be present. A wholesaler that only acts as a reverse distributor may use either a designated representative or a designated representative-reverse distributor to fulfill this requirement.
- States that the fee for application, investigation, and issuance of a license as a designated representative, or as a designated representative-3PL, or as a designated representative-reverse distributor shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
- States that the fee for the annual renewal of a license as a designated representative, designated representative-3PL, or designated representative-reverse distributor shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
FISCAL EFFECT: According to the May 1, 2017 Senate Committee on Appropriations analysis, this bill will likely result in ongoing costs of $50,000 to $100,000 per year for the Board to license the new category of licensee, and one-time costs of $50,000 for the Board to upgrade their information technology systems to issue the new licenses.
COMMENTS:
Purpose. This bill is sponsored by the Board of Pharmacy. According to the author, “Current law allows for reverse distributors. They are in charge of receiving, inventorying, warehousing, and managing the disposition of outdated or non-saleable dangerous drugs. However, it seems that some of the requirements for receiving a license for reverse distributor may not be necessary when the individual is working for a business whose sole business model is handling dangerous drugs and pharmaceutical waste for destruction. SB 752 establishes, through the creation of a new licensing category, a designated representative license for individuals working in a reverse distributor.”
Background. Pharmacist Practice and Regulation. Pharmacists are healthcare professionals who understand the biochemical mechanisms and actions of drugs, drug uses, therapeutic roles, side effects, potential drug interactions, and monitoring parameters. Pharmacists provide counseling on the appropriate use and effects of prescribed drugs. In California, pharmacists are regulated by the Board. There are 42,691 pharmacists and 70,624 pharmacy technicians with active licenses in the state.
Regulation of Pharmacies. There are 7081 pharmacies regulated by the Board. Of these, 513 are hospital pharmacies. The Board reported it also regulates 506 non-resident pharmacies which generally include mail order pharmacies. The Board has additional licenses for those pharmacies that perform sterile compounding and are located in California (890) and ship into California from another state (91).
Reverse Distribution. In the course of normal operations, health care providers and pharmacies accumulate pharmaceuticals that they will not use or dispense. A reverse distributor is an individual who acts as an agent for pharmacies, drug wholesalers, 3PLs, manufacturers and other entities by receiving, inventorying, warehousing, and managing the disposition of outdated or non-saleable dangerous drugs. There are 568 wholesalers, 740 out of state wholesalers, 23 third party logistics providers, and 65 out of state 3PLs licensed by the Board.
Even though old, unused controlled substances constitute only 10% of all prescription drugs in the distribution system, they cause environmental problems when they’re flushed down the toilet at home or at an institution. The environmental threat to lakes, streams, and rivers from discarded pharmaceuticals is a growing concern (Pharmacy and Therapeutics, 2009).
Federal Environmental Protection Agency (EPA) Proposed Regulations on Reverse Distribution. In 2015, “…in an attempt to bring consistency to the varying approaches taken by states” the EPA proposed rules to broaden the scope of regulation of reverse distribution. The EPA expanded the definition of pharmaceutical to include medication, dietary supplements, and any items containing pharmaceutical residuals, such as IV bags, unit dose packages, personal protective clothing contaminated with medications, and any spilled materials. The EPA also redefined waste to include all medications sent by a healthcare facility to a reverse distributor, regardless of whether they are eligible for credit. It also established numerous additional requirements for reverse distribution facilities, including notification to EPA; requiring all shipments be evaluated for hazardous waste content within 21 days of receipt; maintenance of records of all shipments received and maintenance of an inventory of all potentially creditable waste materials; and additional security, closure, and reporting requirements for such facilities were also proposed (Environmental Law Alert, 2015).
Designated Representatives. Wholesale operations that distribute dangerous drugs or dangerous devices must have a Wholesaler License and must be supervised by a registered pharmacist or an individual approved by the Board as a designated representative who is responsible for ensuring compliance with all state and federal laws and regulations pertaining to practice. These companies may not operate unless the pharmacist or designated representative is physically on the licensed premises. The designated representative must either demonstrate one year of paid work experience related to the distribution or dispensing of dangerous drugs or devices in a licensed pharmacy, drug wholesaler, drug distributor or drug manufacturer, or be eligible to take the pharmacy licensure examination. In addition, the designated representative must complete a training program approved by the Board and demonstrate knowledge of California and federal law regarding distribution of dangerous drugs and devices, controlled substances, pharmacopoeia standards relating to safe storage and handling of drugs, and knowledge of prescription terminology and dosages. There are 1,831 designated representatives, 35 veterinary food animal drug retailer designated reps, and 114 3PL designated representatives licensed by the Board.
Prior Related Legislation. AB 2605 (Bonilla, Chapter 507, Statutes of 2014) created a Board 3PL and nonresident 3PL provider license for an entity that handles and transports dangerous drugs and devices.
SB 1308 (Committee on Business and Professions, Chapter 655, Statutes of 1999) created the reverse distributor category.
ARGUMENTS IN SUPPORT:
The Board of Pharmacy (sponsor) writes in support, “The board believes there is benefit to creating specialized category of licensure for the designated representative that will oversee the operations of the reverse distributors. Currently, designated representatives are licensed based on their experience in the distribution of medication from manufacturers to pharmacies and practitioners. We believe that emerging efforts to destroy unwanted drugs through take-back programs warrants the board’s efforts to create a licensing category that more clearly reflects the minimum qualifications someone must meet to perform the duties of disposal and destruction of medications from the supply chain.”
ARGUMENTS IN OPPOSITION:
None on file.
REGISTERED SUPPORT:
Board of Pharmacy (sponsor)
REGISTERED OPPOSITION:
None on file.
Analysis Prepared by: Le Ondra Clark Harvey, Ph.D. / B. & P. / (916) 319-3301
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | SB |
THIRD READING
Bill No: SB 752
:
SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 9-0, 4/17/17
AYES: Hill, Bates, Dodd, Galgiani, Glazer, Hernandez, Newman, Pan, Wilk
SENATE APPROPRIATIONS COMMITTEE: 7-0, 5/1/17
AYES: Lara, Bates, Beall, Bradford, Hill, Nielsen, Wiener
SOURCE: California Board of Pharmacy
DIGEST:
This bill establishes a “designated representative-reverse distributor” license.
Existing law:
- Establishes the Board of Pharmacy (BOP) within the Department of Consumer Affairs to administer and enforce the Pharmacy Law. (Business and Professions Code Section § 4001)
- Defines a “designated representative” as an individual to whom a license has been granted, as specified, but that a pharmacist fulfilling the duties of a designated representative is not required to obtain a license as a designated representative. (BPC § 4022.5 (a))
- Defines a “designated representative-in-charge” as a designated representative or a pharmacist proposed by a wholesaler or veterinary food-animal drug retailer and approved by the BOP as the supervisor or manager responsible for ensuring compliance with all state and federal laws and regulations pertaining to practice in the applicable license category. (BPC § 4022.5 (b))
- Establishes requirements for licensure as a designated representative and specifies that a designated representative provide sufficient and qualified supervision in a wholesaler or veterinary food-animal drug retailer and shall protect the public health and safety in the handling, storage, and shipment of dangerous drugs and dangerous devices in the wholesaler or veterinary food-animal drug retailer. (BPC § 4053)
- Defines a “reverse distributor” as every person who acts as an agent for pharmacies, drug wholesalers, third-party logistics providers (3PL), manufacturers, and other entities by receiving, inventorying, warehousing, and managing the disposition of outdated or nonsaleable dangerous drugs.
(BPC § 4040.5)
This bill:
- Establishes a designated representative-reverse distributor (DRRD) license.
- Defines a DRRD as a licensed individual who is responsible for supervision over a licensed wholesaler that only acts as a reverse distributor. A pharmacist fulfilling these duties shall not be required to obtain a license as a DRRD.
- Adds a DRRD to the definition of a designated representative in charge.
- Adds the receiving, inventorying, warehousing, and managing the disposition of outdated or nonsaleable dangerous devices to the duties of a reverse distributor.
- Authorizes the BOP to issue a DRRD to a qualified individual who shall provide sufficient and qualified supervision over a licensed wholesaler that only acts as a reverse distributor. The designated representative-reverse distributor shall protect the public health and safety in the handling, storage, warehousing, and destruction of outdated or nonsaleable dangerous drugs and dangerous devices.
- An applicant for a DRRD license must:
- Be at least 18 years of age;
- Be a high school graduate or possess a general education development certificate equivalent;
- Meet one of the following requirements:
- Have a minimum of one year of paid work experience in the past three years with a licensed wholesaler, 3PL, or pharmacy performing duties related to the distribution, dispensing, or destruction of dangerous drugs or dangerous devices;
- Have a minimum of one year of paid work experience in the destruction of outdated or nonsaleable dangerous drugs or dangerous devices pharmaceutical waste; or,
- Meet all of the prerequisites to take the examination required for licensure as a pharmacist by the BOP.
- Complete a training program approved by the BOP that, at a minimum, addresses each of the following subjects:
- Knowledge and understanding of California law and federal law relating to the distribution of dangerous drugs and dangerous devices;
- Knowledge and understanding of California law and federal law relating to the distribution of controlled substances;
- Knowledge and understanding of California law and federal law relating to the removal and destruction of dangerous drugs, dangerous devices, and pharmaceutical waste;
- Knowledge and understanding of the United States Pharmacopoeia or federal Food and Drug Administration standards relating to the safe storage, handling, and transport of dangerous drugs and dangerous devices.
- Authorizes the BOP to require the training program to include additional material.
- Requires the applicant to show proof of completion to the BOP of the training required prior to obtaining a license as a DRRD.
- Prohibits a reverse distributor from operating without at least one designated representative or DRRD present at each of its licensed places of business, as specified.
- Adds a DRRD to the list of individuals who may sign for and receive delivery of dangerous drugs or dangerous devices at a licensed premise, as specified.
- Requires a designated 3PL and DRRD to notify the BOP Executive Officer within 30 days after changing his or her address of record or after legally changing his or her name.
- Authorizes a wholesaler who only acts as a reverse distributor to use either a designated representative or a DRRD to satisfy the requirement that the wholesaler have at least one designated representative present at all times it is open for business.
- Authorizes a wholesaler who only acts as a reverse distributor to identify and allow a DRRD to act in the capacity of a designated representative in charge.
- Establishes a fee range for application and annual renewal of a DRRD license to be between $150-$210 and $215-$300, respectively.
- Makes technical changes.
Background
The BOP currently recognizes entities who handle the disposition of outdated or non-saleable dangerous drugs to other licensees as a “reverse distributor.” Current law also considers someone who sells for resale, or negotiates for distribution, or takes possession of, any drug or device, a wholesaler. Therefore, a reverse distributor is also a wholesaler.
A wholesaler is required to have a designated representative onsite in order to conduct business, and one of these individuals must be deemed “in charge” who is responsible for the wholesaler’s compliance with state and federal laws governing wholesalers.
This bill creates a specialized designated representative license for an entity whose only business is handling dangerous drugs and devices for destruction.
According to the Author’s office, “When assessing the current requirements for a designated representative, it seems that some of the requirements may not be necessary when the individual is working for a business whose sole business model is handling dangerous drugs and pharmaceutical waste for destruction.
“As background, the BOP learned of this issue from a company that received approval to dispose of pharmaceutical waste using a high heat technology that is more environmentally friendly that incineration. However, as part of the company’s approval process from various state and federal regulators, the company was advised [by the DEA] that it must also be licensed by the board as a reverse distributor. The company expressed challenges with finding individuals that meet the licensing requirements as a designated representative and questioned if the requirements are appropriate for this type of business model.”
FISCAL EFFECT: Appropriation: Fiscal Com.: Local:
According to the Senate Committee on Appropriations:
- Likely ongoing costs of $50,000 to $100,000 per year for the BOP to license the new category of licensee (Pharmacy Board Contingent Fund).
- Likely one-time costs of $50,000 for the BOP to upgrade their information technology systems to issue the new licenses (Pharmacy Board Contingent Fund).
California Board of Pharmacy (source)
Medical Waste Services
None received
ARGUMENTS IN SUPPORT: The BOP writes, “Reverse distributors process or manage the disposition of outdated or unsaleable drugs. We believe that such a business model warrants the board’s efforts to create a licensing category that more clearly reflects the minimum qualifications someone must meet to perform the duties of disposal and destruction of medications from the supply chain. This measure is consistent with this goal.”
5/3/17 15:18:28
**** END ****
SENATE COMMITTEE ON APPROPRIATIONS
Senator Ricardo Lara, Chair
2017 - 2018 Regular Session
SB 752 (Stone) - Pharmacy: designated representative-reverse distributors
Version: March 28, 2017 | Policy Vote: B., P. & E.D. 9 - 0 |
Urgency: No | Mandate: Yes |
Hearing Date: May 1, 2017 | Consultant: Brendan McCarthy |
This bill does not meet the criteria for referral to the Suspense File.
Bill Summary:
SB 752 would establish a “designated representative-reverse distributor” license under the Board of Pharmacy.
Fiscal Impact:
- Likely ongoing costs of $50,000 to $100,000 per year for the Board of Pharmacy to license the new category of licensee (Pharmacy Board Contingent Fund).
- Likely one-time costs of $50,000 for the Board of Pharmacy to upgrade their information technology systems to issue the new licenses (Pharmacy Board Contingent Fund).
Background:
Under current law, the Board of Pharmacy licenses and regulates pharmacists and pharmacies. Under current law, the Board of Pharmacy recognizes entities that handle the disposition of outdated drugs as a “reverse distributors”, which are considered drug wholesalers for licensing purposes. Therefore, a reverse distributor needs to meet licensing requirements designed for drug wholesalers. Concerns have been raised that the licensing requirements that are currently applied to reverse distributors are needlessly stringent for the activities undertaken by entities that only collect outdated drugs for disposal.
Proposed Law:
SB 752 would establish a “designated representative-reverse distributor” license under the Board of Pharmacy.
Specific provisions of the bill would:
- Establish a new designated representative-reverse distributor license;
- Establish the licensing requirements for a designated representative-reverse distributor license;
- Require a reverse distributor to have at least one designated representative or designated representative-reverse distributor at each place of business;
- Require application and renewal fees for a designated representative-reverse distributor license.
Staff comments: The license category created in this bill is designed for companies that only collect outdated drugs for disposal. The bill would allow the Board to regulate such entities, without imposing licensing requirements that are not necessary for that business model.
-- END --
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2017 - 2018 Regular
Bill No: SB 752 Hearing Date: April 17, 2017
Author: | Stone | ||
Version: |
| ||
Urgency: | Fiscal: | ||
Consultant: | |||
Subject: Pharmacy: designated representative-reverse distributors
SUMMARY:
Establishes a “designated representative-reverse distributor” license.
Existing law:
- Establishes the Board of Pharmacy (BOP) within the Department of Consumer Affairs to administer and enforce the Pharmacy Law. (Business and Professions Code Section § 4001)
- Defines a “designated representative” as an individual to whom a license has been granted, as specified, but that a pharmacist fulfilling the duties of a designated representative is not required to obtain a license as a designated representative. (BPC § 4022.5 (a))
- Defines a “designated representative-in-charge” as a designated representative or a pharmacist proposed by a wholesaler or veterinary food-animal drug retailer and approved by the BOP as the supervisor or manager responsible for ensuring compliance with all state and federal laws and regulations pertaining to practice in the applicable license category. (BPC § 4022.5 (b))
- Establishes requirements for licensure as a designated representative and specifies that a designated representative provide sufficient and qualified supervision in a wholesaler or veterinary food-animal drug retailer and shall protect the public health and safety in the handling, storage, and shipment of dangerous drugs and dangerous devices in the wholesaler or veterinary food-animal drug retailer.
(BPC § 4053) - Defines a “reverse distributor” as every person who acts as an agent for pharmacies, drug wholesalers, third-party logistics providers (3PL), manufacturers, and other entities by receiving, inventorying, warehousing, and managing the disposition of outdated or nonsaleable dangerous drugs. (BPC § 4040.5)
This bill:
- Establishes a designated representative-reverse distributor (DRRD) license.
- Defines a DRRD as a licensed individual who is responsible for supervision over a licensed wholesaler that only acts as a reverse distributor. A pharmacist fulfilling these duties shall not be required to obtain a license as a DRRD.
- Adds a DRRD to the definition of a designated representative in charge.
- Adds the receiving, inventorying, warehousing, and managing the disposition of outdated or nonsaleable dangerous devices to the duties of a reverse distributor.
- Authorizes the BOP to issue a DRRD to a qualified individual who shall provide sufficient and qualified supervision over a licensed wholesaler that only acts as a reverse distributor. The designated representative-reverse distributor shall protect the public health and safety in the handling, storage, warehousing, and destruction of outdated or nonsaleable dangerous drugs and dangerous devices.
- An applicant for a DRRD license must:
- Be at least 18 years of age;
- Be a high school graduate or possess a general education development certificate equivalent;
- Meet one of the following requirements:
- Have a minimum of one year of paid work experience in the past three years with a licensed wholesaler, 3PL, or pharmacy performing duties related to the distribution, dispensing, or destruction of dangerous drugs or dangerous devices;
- Have a minimum of one year of paid work experience in the destruction of outdated or nonsaleable dangerous drugs or dangerous devices pharmaceutical waste; or,
- Meet all of the prerequisites to take the examination required for licensure as a pharmacist by the BOP.
- Complete a training program approved by the BOP that, at a minimum, addresses each of the following subjects:
- Knowledge and understanding of California law and federal law relating to the distribution of dangerous drugs and dangerous devices;
- Knowledge and understanding of California law and federal law relating to the distribution of controlled substances;
- Knowledge and understanding of California law and federal law relating to the removal and destruction of dangerous drugs, dangerous devices, and pharmaceutical waste;
- Knowledge and understanding of the United States Pharmacopoeia or federal Food and Drug Administration standards relating to the safe storage, handling, and transport of dangerous drugs and dangerous devices.
- Authorizes the BOP to require the training program to include additional material.
- Requires the applicant to show proof of completion to the BOP of the training required prior to obtaining a license as a DRRD.
- Prohibits a reverse distributor from operating without at least one designated representative or DRRD present at each of its licensed places of business, as specified.
- Adds a DRRD to the list of individuals who may sign for and receive delivery of dangerous drugs or dangerous devices at a licensed premise, as specified.
- Requires a designated 3PL and DRRD to notify the BOP Executive Officer within 30 days after changing his or her address of record or after legally changing his or her name.
- Authorizes a wholesaler who only acts as a reverse distributor to use either a designated representative or a DRRD to satisfy the requirement that the wholesaler have at least one designated representative present at all times it is open for business.
- Authorizes a wholesaler who only acts as a reverse distributor to identify and allow a DRRD to act in the capacity of a designated representative in charge.
- Establishes a fee range for application and annual renewal of a DRRD license to be between $150-$210 and $215-$300, respectively.
- Makes technical changes.
FISCAL EFFECT:
Unknown. This bill is keyed “fiscal” by the Legislative Counsel.
COMMENTS:
- Purpose. This bill is sponsored by the Board of Pharmacy. According to the Author’s office, “When assessing the current requirements for a designated representative, it seems that some of the requirements may not be necessary when the individual is working for a business whose sole business model is handling dangerous drugs and pharmaceutical waste for destruction.
“As background, the BOP learned of this issue from a company that received approval to dispose of pharmaceutical waste using a high heat technology that is more environmentally friendly that incineration. However, as part of the company’s approval process from various state and federal regulator the company was advised that it must also be licensed by the board as a reverse distributor (a DEA requirement). The company expressed challenges with finding individuals that meet the licensing requirements as a designated representative and questioned if the requirements are appropriate for this type of business model.”
- Background. The BOP currently recognizes entities who handle the disposition of outdated or non-saleable dangerous drugs to other licensees as a “reverse distributor.” Current law also considers someone who sells for resale, or negotiates for distribution, or takes possession of, any drug or device, a wholesaler. Therefore, a reverse distributor is also a wholesaler.
A wholesaler is required to have a designated representative onsite in order to conduct business, and one of these individuals must be deemed “in charge” who is responsible for the wholesaler’s compliance with state and federal laws governing wholesalers.
This bill creates a specialized designated representative license for an entity whose only business is handling dangerous drugs and devices for destruction.
- Prior Legislation. AB 2605 (Bonilla, Chapter 507, Statutes of 2014) created a BOP 3PL and nonresident 3PL provider license for an entity that handles and transports dangerous drugs and devices.
SB 1308 (Committee on Business and Professions, Chapter 655, Statutes of 1999) created the reverse distributor category.
- Arguments in Support. The BOP writes, “Reverse distributors process or manage the disposition of outdated or unsaleable drugs. We believe that such a business model warrants the board’s efforts to create a licensing category that more clearly reflects the minimum qualifications someone must meet to perform the duties of disposal and destruction of medications from the supply chain. This measure is consistent with this goal.”
SUPPORT AND OPPOSITION:
Support:
Board of Pharmacy (Sponsor)
Opposition:
None on file as of April 11, 2017
-- END --
Discussed in Hearing
1MIN
Assembly Floor
1MIN
Assembly Floor
2MIN
Assembly Standing Committee on Business and Professions
1MIN
Senate Floor
1MIN
Senate Standing Committee on Appropriations
2MIN
Senate Standing Committee on Business, Professions and Economic Development
Bill Author
Bill Co-Author(s):