Date of Hearing: July 10, 2019

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez, Chair

SBPCA Bill Id:SB 655

Author:(Roth) – As Amended Ver:April 11, 2019

Urgency: No State Mandated Local Program: Yes Reimbursable: No

SUMMARY:

This bill makes various changes to regulation of pharmacy, including increasing the number of hours required for a pharmacy technician training program, modifying procurement rules for a reverse distributor (an entity that collects and processes unwanted or unused drugs), updating renewal requirements for an advanced practice pharmacist, requiring licensing fees for government entities, and additional technical changes.

FISCAL EFFECT:

1. Increased revenues of $450,000 based on striking the fee exemption for governmental pharmacies (Pharmacy Board Contingent Fund).
2. Minor and absorbable workload associated with the education of licensees and other health care providers and cost of $34,000 for the creation of additional fee codes (Pharmacy Board Contingent Fund).
3. Unknown, likely minor GF costs will be incurred for payments of fees to the Board of Pharmacy for pharmacies administered by California Correctional Health Care Services and Department of State Hospitals.

COMMENTS:

Purpose and Background. The Board of Pharmacy (Board) licenses and regulates a variety of professionals and entities including pharmacies, pharmacists, advanced practice pharmacists, pharmacy technicians and reverse distributors.

This omnibus bill, sponsored by the Board, is intended to enact a variety of changes to modernize the Pharmacy Law and support the Board’s mission. The bill makes various technical changes and minor policy changes the Board believes are necessary to conduct its work on behalf of the public.

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

Date of Hearing: June 25, 2019

ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS

Evan Low, Chair

SBPCA Bill Id:SB 655

Author:(Roth) – As Amended Ver:April 11, 2019

SENATE VOTE: 38-0

SUBJECT: Pharmacy

SUMMARY: Makes various technical changes and updates to the Pharmacy Law by increasing the number of hours required for a pharmacy technician externship program; authorizing a reverse distributor to acquire a dangerous drug or device from a source that was previously licensed; updating renewal requirements for an advanced practice pharmacist; requiring licensing fees for government entities; and additional technical changes.

EXISTING LAW:

1. Establishes the Board of Pharmacy (Board) to administer and regulate the Pharmacy Law. (Business and Professions Code (BPC) § 4001)
2. Provides that protection of the public shall be the highest priority for the Board in exercising its licensing, regulatory, and disciplinary functions. (BPC § 4001.1)
3. Authorizes the Board to adopt rules and regulations as may be necessary for the protection of the public. (BPC § 4005)
4. Declares pharmacy practice to be “a dynamic, patient-oriented health service that applies a scientific body of knowledge to improve and promote patient health by means of appropriate drug use, drug-related therapy, and communication for clinical and consultative purposes” and that “pharmacy practice is continually evolving to include more sophisticated and comprehensive patient care activities.” (BPC § 4050)
5. Defines “pharmacy” as an area, place, or premises licensed by the Board in which the profession of pharmacy is practiced and where prescriptions are compounded. (BPC § 4037)
6. Defines “pharmacy technician” as an individual who assists a pharmacist in a pharmacy in the performance of their pharmacy-related duties. (BPC § 4038)
7. Establishes the following qualifications for a pharmacy technician license:
   1. The applicant is a high school graduate or possesses a general educational development certificate equivalent, and has either obtained an associate’s degree in pharmacy technology, completed a course of training specified by the Board, graduated from a school of pharmacy, or been certified by a certifying organization offering accredited by the National Commission for Certifying Agencies that is approved by the Board.
   2. The applicant passes a criminal background check.

(BPC § 4202)

1. Requires that dangerous drugs or dangerous devices be acquired from a person authorized by law to possess or furnish dangerous drugs or dangerous devices; if the person acquiring the dangerous drugs or dangerous devices is a wholesaler, further states that the obligation of the wholesaler shall be limited to obtaining license confirmation from those sources from whom it has not previously acquired dangerous drugs or dangerous devices. (BPC § 4163)
2. Establishes requirements for recognition as an advanced practice pharmacist. (BPC § 4210)
3. Exempts governmental pharmacies from licensing fees. (BPC § 4400)

THIS BILL:

1. Requires a pharmacy technician trainee externship to consist of no fewer than 120 hours and no more than 140 hours.
2. Upon approval of the Board, authorizes a reverse distributor licensed as a wholesaler to acquire a dangerous drug or dangerous device from an unlicensed source that was previously licensed with the Board for the sole purpose of destruction of the dangerous drug or device.
3. Provides that a pharmacy applicant may have either passed the North American Pharmacist Licensure Examination on or after January 1, 2004, holding an active pharmacist license in another state or territory of the United States; or at a time when the exam was based on an occupational analysis that is either current or that was replaced by another occupational analysis no more than one year before the application for licensure.
4. Sets forth the requirements for an advanced practice pharmacist recognition to be renewed through the submission of the following:
   1. Application and payment of the renewal fees.
   2. Proof satisfactory to the board that the licensee has completed 10 hours of continuing education, with the 10 hours in addition to the continuing education requirements necessary for a pharmacist license.
5. Allows the Board to issue an inactive advanced practice pharmacist recognition under any of the following conditions:
   1. The pharmacist’s license becomes inactive.
   2. The advanced practice pharmacist fails to provide documentation of the completion of the required continuing education.
   3. As part of an investigation or audit conducted by the board, the advanced practice pharmacist fails to provide documentation substantiating the completion of continuing education.
6. Removes the exemption for governmental entities from license fees.

FISCAL EFFECT: According to the Senate Committee on Appropriations, approximately $450,000 of revenue to the Board with $34,000 in expenditures for information technology to create additional fee codes, as well as impacts to state and governmentally owned facilities comprised of various amounts due to the removal of their current fee exemption.

COMMENTS:

Purpose. This bill is sponsored by the California State Board of Pharmacy. According to the author:

“This bill addresses changes sought by the California State Board of Pharmacy (BOP) to bring conformity to pharmacy law, ensure minimum competency, remove barriers to licensure, and seek alignment with stipulated requirements. Specifically, these technical changes will ensure examination outcomes are an accurate reflection of competency, align minimum hour requirements, align continuing education renewal requirements, allow a reverse distributor to accept medications for destruction (under limited circumstances) from an unlicensed location, allow the BOP to assess fees from government-owned facilities (beginning July 1, 2021), and clarify existing fee structures.”

Background. The California State Board of Pharmacy (Board) is responsible for licensing and regulating a variety of professionals and entities involved in carrying out the provisions of the Pharmacy Law. This includes pharmacists, advanced practice pharmacists, pharmacy technicians, and reverse distributors. By providing standardized requirements within the various settings where drugs and medications may be furnished to patients, the Board has responsibility for protecting the public and advancing the pharmacy profession within the state.

This bill, sponsored by the Board, is intended to enact a variety of changes to the Pharmacy Law to modernize the act and support the Board’s mission. The bill would make various technical changes and corrections to existing law. It would further accommodate various minor policy changes believed by the Board to be in support of its work on behalf of the public. The author believes that passage of this bill will allow the Board to better carry out its work on behalf of the People of California as relates to the regulation of pharmacists, pharmacies, and associated entities.

ARGUMENTS IN SUPPORT:

This bill is sponsored by the California State Board of Pharmacy. According to the Board, “the board is a consumer protection agency charged with regulating the practice of pharmacy. The board fulfills its mission primarily through licensing, education, and enforcement activities. The board seeks to amend several provisions of pharmacy law to bring conformity, ensure minimum competency, remove barriers to licensure, and seek alignment with requirements.”

ARGUMENTS IN OPPOSITION:

None on file.

REGISTERED SUPPORT:

California State Board of Pharmacy (Sponsor)

REGISTERED OPPOSITION:

None on file.

Analysis Prepared by: Robert Sumner / B. & P. / (916) 319-3301

 THIRD READING  

Bill No: SB 655

Author: Roth (D)

Amended: 4/11/19

Vote: 21

SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 9-0, 4/8/19

AYES: Glazer, Chang, Archuleta, Dodd, Galgiani, Hill, Leyva, Pan, Wilk

SENATE APPROPRIATIONS COMMITTEE: 6-0, 5/16/19

AYES: Portantino, Bates, Bradford, Hill, Jones, Wieckowski

SUBJECT: Pharmacy

SOURCE: California State Board of Pharmacy

DIGEST:

This bill increases the hours requirement for a pharmacy technician externship program, authorizes a reverse distributor to acquire a dangerous drug or device from a previously licensed source, updates renewal requirements for an advanced pharmacist recognition, requires licensing fees for government entities, and makes technical changes, as specified.

ANALYSIS:

Existing law:

1. Establishes the California State Board of Pharmacy (BOP) within the Department of Consumer Affairs (DCA) to administer and enforce the Pharmacy Law. (Business and Professions Code (BPC) § 4001).
2. Defines a pharmacy technician trainee (PTT) as a person who is enrolled in a pharmacy technician training program operated by a California public postsecondary educational institution or by a private postsecondary vocational institution approved by the Bureau for Private Postsecondary and Vocational Education. (BPC § 4038 (b))
3. Establishes the following qualifications for a pharmacy technician (PT) license:
   1. The applicant is a high school graduate or possesses a general educational development certificate equivalent, and meets any one of the following requirements:
      1. Has obtained an associate’s degree in pharmacy technology.
      2. Has completed a course of training specified by the BOP.
      3. Has graduated from a school of pharmacy recognized by the BOP.
      4. Is certified by a PT certifying organization offering a PT certification program accredited by the National Commission for Certifying Agencies that is approved by the BOP.
   2. The applicant passes a criminal background check. (BPC § 4202)
4. Requires that dangerous drugs or dangerous devices be acquired from a person authorized by law to possess or furnish dangerous drugs or dangerous devices. If the person acquiring the dangerous drugs or dangerous devices is a wholesaler, the obligation of the wholesaler shall be limited to obtaining license confirmation from those sources from whom it has not previously acquired dangerous drugs or dangerous devices. (BPC § 4163)
5. Establishes licensing requirements for pharmacists, including that an applicant must pass the North American Pharmacist Licensure Examination (NAPLEX) and the California Practice Standards and Jurisprudence Examination for Pharmacists (CPJE), on or after January 1, 2004. (BPC § 4200)
6. Establishes requirements for recognition as an advanced practice pharmacist (APP). (BPC § 4210)
7. Exempts governmental pharmacies from licensing fees. (BPC § 4400)

This bill:

1. Increases the hour requirements for a PTT externship program from no more than 120 hours to between 120 and140 hours.
2. Increases the externship hours from 320 to 340 hours for a rotation between a community and hospital pharmacy for the purpose of training a PTT student in distinct practice settings, and deletes the requirement that no more than 120 hours may be completed in a community pharmacy setting or a single department in a hospital setting.
3. Authorizes a reverse distributor licensed as a wholesaler to acquire a dangerous drug or dangerous device from an unlicensed source that was previously licensed with the BOP for the sole purpose of destroying the dangerous drug or dangerous device, upon approval of the BOP.
4. Continues to require that an applicant for pharmacist licensure pass the NAPLEX, but the applicant may either:
   1. Passed that exam on or after January 1, 2004, and has an active pharmacist license in another state or territory of the United States, or
   2. At the time of license application, the NAPLEX was based on an occupational analysis that is either current or that was replaced by another occupational analysis no more than one year before license application.
5. Requires an applicant for pharmacist licensure pass a version of the CJPE that, at the time of application for licensure, was based on an occupational analysis that is either current or that was replaced by another occupational analysis no more than one year before the application for licensure.
6. Establishes the following requirements for APP recognition renewal:
   1. A current and active pharmacist license.
   2. Application and payment of the renewal fees.
   3. Proof satisfactory to the BOP that the licensee has completed 10 hours of continuing education (CE), in addition to the CE requirements necessary for a pharmacist license renewal.
7. Requires an APP to retain documentation of CE completion for four years.
8. Exempts APP CE requirements for the first renewal of an APP recognition.
9. Authorizes the BOP to issue an inactive APP recognition under any of the following conditions:
   1. The pharmacist’s license becomes inactive.
   2. The APP fails to provide documentation of CE completion, including as part of an audit or investigation by the BOP.
10. Requires the BOP to reactivate an inactive APP recognition only if the applicant pays the required renewal fees, submits satisfactory proof to the BOP of CE completion, and meets all other renewal requirements.
11. Removes the exemption for governmental entities for license fees beginning July 1, 2021.
12. Makes technical changes.

Background

The BOP regulates the practice of pharmacies, pharmacists, interns, PTs, and exemptees (those who are involved with the wholesale or manufacturer of drugs and medical devices, but not required to hold a pharmacist license). The BOP also regulates all types of firms that distribute prescription drugs and devices in California, including community pharmacies and those located in hospitals, clinics, home and community support services facilities, and out-of-state mail order pharmacies that fill prescriptions and deliver them in California.

In 2018, the BOP issued 139,640 licenses, registrations, permits, and certificates. Of those, over 35,000 were PT licenses, 22,000 were pharmacist licenses, and nearly 300 were APP recognitions.

The BOP is totally self-funded and receives no tax money from the General Revenue Fund of the State of California. Funds necessary for its operation are generated primarily through its licensing fees.

This bill will:

• Establish that a passing score on the NAPLEX or CPJE examinations would be valid only while the occupational analysis used to develop the examination is valid or was replaced no more than one year prior. This will ensure the examinations are an accurate reflection of the candidate’s competency at the time the individual is seeking licensure;
• Increase the maximum number of hours a PTT must gain during an externship and removes a conflict in the hours requirement for completing an ASHP-accredited PT training program. This amendment raises the BOP’s requirements to align with the ASHP’s minimum hour requirements.
• Align the APP recognition CE renewal requirements with pharmacist license CE renewal requirements;
• Allow a reverse distributor to accept medications for destruction under limited circumstances from an unlicensed location, including when a pharmacy license is cancelled;
• Allow the BOP to assess fees from government-owned facilities beginning July 1, 2021; and,
• Clarify the fees for updating a licensing record and the fee to reissue a printed license certificate.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

According to the Senate Appropriations Committee, unless otherwise noted, the figures provided reflect estimates provided by the DCA. For the BOP, approximately $450,000 of revenue with $34,000 in expenditures for information technology to create additional fee codes. This impact would be funded through the redirection of existing maintenance resources. 

Impacts to state and governmentally owned facilities include:

• Department of Corrections and Rehabilitation (CDCR) has about 83 licenses and appear to include clinics, hospitals, pharmacies, a wholesale license, and a few sterile compounding license: The CDCR estimated the cost to be approximately, $32,345 to $45,130. Specifically:

*Based on the annual renewal fees for a nongovernmental pharmacy license, nongovernmental sterile compounding pharmacy, and reissuing a renewal (BPC Article 23, Section 4400).

• Department of Veterans Affairs has about four licenses for a total of $2,320 (minimum) or $3,150 (maximum).
• Department of Social Services appears to have two hospitals.  $1,330 (minimum) or $1,860 (maximum).
• Emergency Medical Services Authority has one wholesale license $780 (minimum) or $820 (maximum).
• CSU/UC System Schools appear to have about 149 licenses and appear to include clinics, pharmacies, hospitals and sterile compounding facilities.  The approximate cost ranges from about $110,000 (statutory minimum) to $167,000 (statutory maximums.)  Included in these licenses are large medical centers like UCD, UCSF, and UCLA that have numerous licenses as well as student health centers. The California State University provided additional detail, specifically:
• $20,790 at least to $29,820 at most, or approximately $25,000 on average per year (General Fund). 21 out of 23 CSU campuses have a pharmacy (Channel Islands and Monterey Bay do not). As the annual fee for pharmacy licensure renewal would be $665, with a possible increase up to $930 per year, the annual cost of licensure renewal for the CSU system’s pharmacies in total would range from $13,965 to $19,530. The clinic permit renewal would cost $325, with a possible increase up to $360, the total system-wide annual cost of clinic permit renewal would range from $6,825 to $7,560.
• Any changes to licenses such as new medical director or administrators would be $130 to process. While it is unlikely that all or most of the 21 campuses with pharmacies would experience leadership changes within the same year, a leadership change at each campus would result in a cost of $2,730 total, with multiple incidences of turnover at each campus.

SUPPORT: (Verified 5/15/19)

California State Board of Pharmacy (source)

OPPOSITION: (Verified 5/15/19)

None received

ARGUMENTS IN SUPPORT: The BOP writes, “The [BOP] is a consumer protection agency charged with regulating the practice of pharmacy. The [BOP] fulfills its mission primarily through licensing, education, and enforcement activities. The [BOP] seeks to amend several provisions of pharmacy law to bring conformity, ensure minimum competency, remove barriers to licensure, and seek alignment with requirements.”

Prepared by: Sarah Huchel / B., P. & E.D. /

5/18/19 13:07:47

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SENATE COMMITTEE ON APPROPRIATIONS

Senator Anthony Portantino, Chair

2019 - 2020 Regular Session

SB 655 (Roth) - Pharmacy

Bill Summary:

Senate Bill 655 would require state and governmentally owned facilities to pay licensure and renewal fees to the Board of Pharmacy (Board), and would increase the amount of hours a pharmacy technician trainee must complete in a rotation between a community and hospital pharmacy.

Fiscal Impact:

• Unless otherwise noted, the figures provided reflect estimates provided by the Department of Consumer Affairs. For the Board of Pharmacy, approximately $450,000 of revenue with $34,000 in expenditures for information technology to create additional fee codes. This impact would be funded through the redirection of existing maintenance resources. 

Impacts to state and governmentally owned facilities include:

• Department of Corrections and Rehabilitation (CDCR) has about 83 licenses and appear to include clinics, hospitals, pharmacies, a wholesale license, and a few sterile compounding license: The CDCR estimated the cost to be approximately, $32,345 to $45,130. Specifically:

*Based on the annual renewal fees for a nongovernmental pharmacy license, nongovernmental sterile compounding pharmacy, and reissuing a renewal (BPC Article 23, Section 4400).

• Department of Veterans Affairs (CalVet) has about 4 licenses for a total of $2,320 (minimum) or $3,150 (maximum).
• Department of Social Services (CDSS), appears to have 2 hospitals.  $1,330 (minimum) or $1860 (maximum).
• Emergency Medical Services Authority has one wholesale license $780 (minimum) or $820 (maximum).
• CSU/UC System Schools appear to have about 149 licenses and appear to include clinics, pharmacies, hospitals and sterile compounding facilities.  The approximate cost ranges from about $110,000 (statutory minimum) to $167,000 (statutory maximums.)  Included in these licenses are large medical centers like UCD, UCSF, and UCLA that have numerous licenses as well as student health centers. The California State University provided additional detail, specifically:
• $20,790 at least to $29,820 at most, or approximately $25,000 on average per year (General Fund). 21 out of 23 CSU campuses have a pharmacy (Channel Islands and Monterey Bay do not). As the annual fee for pharmacy licensure renewal would be $665, with a possible increase up to $930 per year, the annual cost of licensure renewal for the CSU system’s pharmacies in total would range from $13,965 to $19,530. The clinic permit renewal would cost $325, with a possible increase up to $360, the total system-wide annual cost of clinic permit renewal would range from $6,825 to $7,560.
• Any changes to licenses such as new medical director or administrators would be $130 to process. While it is unlikely that all or most of the 21 campuses with pharmacies would experience leadership changes within the same year, a leadership change at each campus would result in a cost of $2,730 total, with multiple incidences of turnover at each campus.

Background:

The Board of Pharmacy regulates the practice of pharmacies, pharmacists, interns, pharmacy technicians (PTs), and exemptees (those who are involved with the wholesale or manufacturer of drugs and medical devices, but not required to hold a pharmacist license). The BOP also regulates firms that distribute prescription drugs and devices in California, including community pharmacies and those located in hospitals, clinics, home and community support services facilities, and out-of-state mail order pharmacies that fill prescriptions and deliver them in California.

According to the Senate Business, Professions, and Economic Development analysis on this bill, in 2018, the Board regulated 139,640 licenses, registrations, permits, and certificates. Of those, over 35,000 were pharmacy technician licenses, 22,000 were pharmacist licenses, and around 300 were advanced practice pharmacist (APP) recognitions. The Board already inspects and licenses state and other governmentally owned facilities, however the fees are currently waived. 

Proposed Law:

The bill includes the following provisions:

Externship Hours.

• Increases the hour requirements, from no more than 120 hours to between 120 and 140 hours, for a pharmacy technician trainee (PTT) externship program.
• Increases the externship hours from 320 to 340 hours for a rotation between a community and hospital pharmacy for training a PTT student in distinct practice settings, and deletes the requirement that no more than 120 hours may be completed in a community pharmacy setting or a single department in a hospital.
• Authorizes a reverse distributor licensed as a wholesaler to acquire a dangerous drug or dangerous device from an unlicensed source that was previously licensed with the BOP for the sole purpose of destroying the dangerous drug or dangerous device, upon approval of the BOP.
• Changes from permissive to a requirement that a manufacturer, wholesaler, repackager, or pharmacy is prohibited from furnishing a dangerous drug or dangerous device to an unauthorized person.
• Continues to require that an applicant for pharmacist licensure pass the NAPLEX, but the applicant passed the exam on or after January 1, 2004 under one of two specified scenarios. .

Advanced Practice Pharmacist Renewal.

• Establishes the following requirements for renewal of APP recognition, among other provisions. .
  • Application and payment of the renewal fees.
  • Proof satisfactory to the BOP that the licensee has completed 10 hours of continuing education (CE), in addition to the CE requirements necessary for a pharmacist license renewal.
• Removes the exemption for governmental entities for license fees, effective July 1, 2021.

Fee and Penalty Schedule. Effective July 1, 2021, the bill specifies annual renewal fee, license, application and examination fee, fee and penalty schedules for a pharmacy license, wholesaler or third-party logistics provider, veterinary food-animal drug retailer, non-resident wholesaler that have 21 or more facilities operating nationwide, intern pharmacist license, clinic license, pharmacy technician license, veterinary food-animal drug retailer license, retired license, sterile compounding pharmacy, hospital satellite compounding pharmacy, nonresident sterile compounding pharmacy license, outsourcing facility license, centralized hospital packaging, correctional clinic

Staff Comments:

This is a Board of Pharmacy sponsored bill. There does not appear a consistent policy with respect to whether, or why, government owned pharmacies have been exempt from application and renewal fees. For example, in 2012, AB 377 (Solorio, Chapter 687) created a centralized hospital packaging licensing program. Government owned pharmacies do pay a fee, ranging from $600 to $800 (BPC 4128.2(h)). There also appears to be inconsistent application statewide. The CDCR does not pay for Correctional Treatment Centers, but does pay for the CLIA Certifications, Radiation Registration renewals, Medical Waster Generator Fees, and Clinical Lab Registration fees.

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SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Steven Glazer, Chair

2019 - 2020 Regular

Bill No: SB 655 Hearing Date: April 8, 2019

Subject: Pharmacy

SUMMARY:

Increases the hours requirement for a pharmacy technician externship program, authorizes a reverse distributor to acquire a dangerous drug or device from a previously licensed source, updates renewal requirements for an advanced pharmacist recognition, requires licensing fees for government entities, and makes technical changes, as specified.

Existing law:

1. Establishes the California State Board of Pharmacy (BOP) within the Department of Consumer Affairs (DCA) to administer and enforce the Pharmacy Law. (Business and Professions Code (BPC) § 4001).
2. Defines a pharmacy technician trainee (PTT) as a person who is enrolled in a pharmacy technician training program operated by a California public postsecondary educational institution or by a private postsecondary vocational institution approved by the Bureau for Private Postsecondary and Vocational Education. (BPC § 4038 (b))
3. Establishes the following qualifications for a pharmacy technician (PT) license:
   1. The applicant is a high school graduate or possesses a general educational development certificate equivalent, and meets any one of the following requirements:
      1. Has obtained an associate’s degree in pharmacy technology.
      2. Has completed a course of training specified by the BOP.
      3. Has graduated from a school of pharmacy recognized by the BOP.
      4. Is certified by a PT certifying organization offering a PT certification program accredited by the National Commission for Certifying Agencies that is approved by the BOP.
   2. The applicant passes a criminal background check. (BPC § 4202)
4. Requires that dangerous drugs or dangerous devices be acquired from a person authorized by law to possess or furnish dangerous drugs or dangerous devices. If the person acquiring the dangerous drugs or dangerous devices is a wholesaler, the obligation of the wholesaler shall be limited to obtaining license confirmation from those sources from whom it has not previously acquired dangerous drugs or dangerous devices. (BPC § 4163)
5. Establishes licensing requirements for pharmacists, including that an applicant must pass the North American Pharmacist Licensure Examination (NAPLEX) and the California Practice Standards and Jurisprudence Examination for Pharmacists (CPJE), on or after January 1, 2004. (BPC § 4200)
6. Establishes requirements for recognition as an advanced practice pharmacist (APP). (BPC § 4210)
7. Exempts governmental pharmacies from licensing fees. (BPC § 4400)

This bill:

1. Increases the hour requirements for a PTT externship program from no more than 120 hours to between 120 and140 hours.
2. Increases the externship hours from 320 to 340 hours for a rotation between a community and hospital pharmacy for the purpose of training a PTT student in distinct practice settings, and deletes the requirement that no more than 120 hours may be completed in a community pharmacy setting or a single department in a hospital setting.
3. Authorizes a reverse distributor licensed as a wholesaler to acquire a dangerous drug or dangerous device from an unlicensed source that was previously licensed with the BOP for the sole purpose of destroying the dangerous drug or dangerous device, upon approval of the BOP.
4. Continues to require that an applicant for pharmacist licensure pass the NAPLEX, but the applicant may either:
   1. Passed that exam on or after January 1, 2004 and has an active pharmacist license in another state or territory of the United States, or
   2. At the time of license application, the NAPLEX was based on an occupational analysis that is either current or that was replaced by another occupational analysis no more than one year before license application.
5. Requires an applicant for pharmacist licensure pass a version of the CJPE that, at the time of application for licensure, was based on an occupational analysis that is either current or that was replaced by another occupational analysis no more than one year before the application for licensure.
6. Establishes the following requirements for APP recognition renewal:
   1. A current and active pharmacist license.
   2. Application and payment of the renewal fees.
   3. Proof satisfactory to the BOP that the licensee has completed 10 hours of continuing education (CE), in addition to the CE requirements necessary for a pharmacist license renewal.
7. Requires an APP to retain documentation of CE completion for four years.
8. Exempts APP CE requirements for the first renewal of an APP recognition.
9. Authorizes the BOP to issue an inactive APP recognition under any of the following conditions:
   1. The pharmacist’s license becomes inactive.
   2. The APP fails to provide documentation of CE completion, including as part of an audit or investigation by the BOP.
10. Requires the BOP to reactivate an inactive APP recognition only if the applicant pays the required renewal fees, submits satisfactory proof to the BOP of CE completion, and meets all other renewal requirements.
11. Removes the exemption for governmental entities for license fees.
12. Makes technical changes.

FISCAL EFFECT:

Unknown. This bill is keyed “fiscal” by the Legislative Counsel.

COMMENTS:

1. Purpose. This bill is sponsored by the BOP. According to the Author’s office, this bill will:

• Establish that a passing score on the NAPLEX or CPJE examinations would be valid only while the occupational analysis used to develop the examination is valid or was replaced no more than one year prior. This will ensure the examinations are an accurate reflection of the candidate’s competency at the time the individual is seeking licensure;
• Increase the maximum number of hours a PTT must gain during an externship and removes a conflict in the hours requirement for completing an ASHP-accredited PT training program. This amendment raises the BOP’s requirements to align with the ASHP’s minimum hour requirements.
• Align the APP recognition CE renewal requirements with pharmacist license CE renewal requirements;
• Allow a reverse distributor to accept medications for destruction under limited circumstances from an unlicensed location, including when a pharmacy license is cancelled;
• Allow the BOP to assess fees from government-owned facilities; and,
• Clarify the fees for updating a licensing record and the fee to reissue a printed license certificate.

1. Background on the BOP. The BOP was formed in 1891 as a state health regulatory agency. In 1971, the BOP became part of the DCA, which is part of the executive branch of the government of the State of California.

The BOP consists of 13 members who are appointed to four-year terms. The Governor appoints seven registered pharmacists and four public members. The Senate Rules Committee and the Speaker of the Assembly each appoint one public member.

The BOP regulates the practice of pharmacies, pharmacists, interns, PTs, and exemptees (those who are involved with the wholesale or manufacturer of drugs and medical devices, but not required to hold a pharmacist license). The BOP also regulates all types of firms that distribute prescription drugs and devices in California, including community pharmacies and those located in hospitals, clinics, home and community support services facilities, and out-of-state mail order pharmacies that fill prescriptions and deliver them in California.

In 2018, the BOP issued 139,640 licenses, registrations, permits, and certificates. Of those, over 35,000 were PT licenses, 22,000 were pharmacist licenses, and nearly 300 were APP recognitions.

The Board is totally self-funded and receives no tax money from the General Revenue Fund of the State of California. Funds necessary for its operation are generated primarily through its licensing fees.

1. Previous related legislation. SB 493 (Hernandez, Chapter 469, Statutes of 2013) established the APP recognition.

SB 1447 (Hernandez, Chapter 666, Statutes of 2018) and revised the requirements for the operation and licensing of an automated drug delivery system (ADDS) after July 1, 2019, and required governmental ADDs to pay fees.

1. Current related legislation. SB 159 (Weiner) of 2019 authorizes a pharmacist to furnish pre- and post-exposure prophylaxis, as specified. Status: This bill is currently pending in the Senate Business, Professions and Economic Development Committee.
2. Arguments in Support. The BOP writes, The [BOP] is a consumer protection agency charged with regulating the practice of pharmacy. The [BOP] fulfills its mission primarily through licensing, education, and enforcement activities. The [BOP] seeks to amend several provisions of pharmacy law to bring conformity, ensure minimum competency, remove barriers to licensure, and seek alignment with requirements.
3. Author’s amendment. The author wishes to amend the bill to delay the implementation of fees on government pharmacist until July 1, 2021, which would give facilities time to plan for the additional costs.

SUPPORT AND OPPOSITION:

Support:

California State Board of Pharmacy

Opposition:

None on file as of April 2, 2019.

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