AB 1069: Prescription drugs: collection and distribution program.
- Session Year: 2015-2016
- House: Assembly
- Latest Version Date: 2016-09-13
Existing law authorizes a county to establish a repository and distribution program under which a pharmacy, including a pharmacy that is owned by, or contracts with, the county, may distribute surplus unused medications, as defined, to persons in need of financial assistance to ensure access to necessary pharmaceutical therapies. Under existing law, only medication that is donated in unopened, tamper-evident packaging or modified unit dose containers that meet the United States Pharmacopoeia standards, and that includes lot numbers and expiration dates, is eligible for donation to the program. Existing law prohibits medication that does not meet the requirements for donation and distribution from being sold, dispensed, or otherwise transferred to any other entity. Existing law requires medication donated to the repository and distribution program to be maintained in the donated packaging units.
This bill would authorize a pharmacy that exists solely to operate the repository and distribution program to repackage a reasonable quantity of donated medicine in anticipation of dispensing the medicine to its patient population. The bill would require a pharmacy that repackages medication to have repackaging policies and procedures in place for identifying and recalling medications, and to label the repackaged medicine with the earliest expiration date.
Existing law authorizes a county to establish a repository and distribution program under which a pharmacy, including a pharmacy that is owned by, or contracts with, the county, may distribute surplus unused medications, as defined, to persons in need of financial assistance to ensure access to necessary pharmaceutical therapies. Under existing law, only medication that is donated in unopened, tamper-evident packaging or modified unit dose containers that meet the United States Pharmacopoeia standards, and that includes lot numbers and expiration dates, is eligible for donation to the program. Existing law prohibits medication that does not meet the requirements for donation and distribution from being sold, dispensed, or otherwise transferred to any other entity. Existing law requires medication donated to the repository and distribution program to be maintained in the donated packaging units.
This bill would authorize a pharmacy that exists solely to operate the repository and distribution program to repackage a reasonable quantity of donated medicine in anticipation of dispensing the medicine to its patient population. The bill would require a pharmacy that repackages medication to have repackaging policies and procedures in place for identifying and recalling medications, and to label the repackaged medicine with the earliest expiration date.
Existing law authorizes a county to establish a repository and distribution program under which a pharmacy, including a pharmacy that is owned by, or contracts with, the county, may distribute surplus unused medications, as defined, to persons in need of financial assistance to ensure access to necessary pharmaceutical therapies. Under existing law, only medication that is donated in unopened, tamper-evident packaging or modified unit dose containers that meet the United States Pharmacopoeia standards, and that includes lot numbers and expiration dates, is eligible for donation to the program. Existing law prohibits medication that does not meet the requirements for donation and distribution from being sold, dispensed, or otherwise transferred to any other entity. Existing law requires medication donated to the repository and distribution program to be maintained in the donated packaging units.
This bill would authorize a pharmacy that exists solely to operate the repository and distribution program to repackage a reasonable quantity of donated medicine in anticipation of dispensing the medicine to its patient population. The bill would require a pharmacy that repackages medication to have repackaging policies and procedures in place for identifying and recalling medications. medications, and to label the repackaged medicine with the earliest expiration date.
Existing law authorizes a county to establish a repository and distribution program under which a pharmacy, including a pharmacy that is owned by, or contracts with, the county, may distribute surplus unused medications, as defined, to persons in need of financial assistance to ensure access to necessary pharmaceutical therapies. Existing law requires a county that establishes a depository and redistribution program to develop written procedures for, among other things, establishing eligibility for medically indigent patients who may participate in the program, and ensuring that patients eligible for the program are not charged for any medications provided under the program. Existing law also prohibits the donation of controlled substances to the repository and distribution program. Under existing law, only medication that is donated in unopened, tamper-evident packaging or modified unit dose containers that meet the United States Pharmacopoeia standards, and that includes lot numbers and expiration dates, is eligible for donation to the program. Existing law authorizes a county-owned pharmacy participating in the program to transfer eligible donated medication to a county-owned pharmacy participating in the program within another adjacent county, as specified. Existing law prohibits medication that does not meet the requirements for donation and distribution from being sold, dispensed, or otherwise transferred to any other entity. Existing law requires medication donated to the repository and distribution program to be maintained in the donated packaging units.
This bill would authorize an entity participating in the medication repository and distribution program to transfer eligible donated medication to a participating entity in any other county, as specified. The bill would generally prohibit an entity from transferring more than 15% of its donated medications annually. The bill would authorize medication donated to a medication repository and distribution program to be maintained in new, properly labeled containers, as specified. The bill would prohibit donated medication from being repackaged more than 2 times. This bill would also make a technical, nonsubstantive change to these provisions.
This bill would authorize a pharmacy that exists solely to operate the repository and distribution program to repackage a reasonable quantity of donated medicine in anticipation of dispensing the medicine to its patient population. The bill would require a pharmacy that repackages medication to have repackaging policies and procedures in place for identifying and recalling medications.
Existing law authorizes a county to establish a repository and distribution program under which a pharmacy, including a pharmacy that is owned by, or contracts with, the county, may distribute surplus unused medications, as defined, to persons in need of financial assistance to ensure access to necessary pharmaceutical therapies. Existing law requires a county that establishes a depository and redistribution program to develop written procedures for, among other things, establishing eligibility for medically indigent patients who may participate in the program, and ensuring that patients eligible for the program are not charged for any medications provided under the program. Existing law also prohibits the donation of controlled substances to the repository and distribution program. Under existing law, only medication that is donated in unopened, tamper-evident packaging or modified unit dose containers that meet the United States Pharmacopoeia standards, and that includes lot numbers and expiration dates, is eligible for donation to the program. Existing law authorizes a county-owned pharmacy participating in the program to transfer eligible donated medication to a county-owned pharmacy participating in the program within another adjacent county, as specified. Existing law prohibits medication that does not meet the requirements for donation and distribution from being sold, dispensed, or otherwise transferred to any other entity. Existing law requires medication donated to the repository and distribution program to be maintained in the donated packaging units.
This bill would authorize a county-owned pharmacy an entity participating in the medication repository and distribution program to transfer eligible donated medication to a participating county-owned pharmacy entity in any other county, as specified. The bill would generally prohibit an entity from transferring more than 15% of its donated medications annually. The bill would authorize medication donated to a medication repository and distribution program to be maintained in new, properly labeled containers. containers, as specified. The bill would prohibit donated medication from being repackaged more than 2 times. This bill would also make a technical, nonsubstantive change to these provisions.
Existing law authorizes a county to establish a repository and distribution program under which a pharmacy, including a pharmacy that is owned by, or contracts with, the county, may distribute surplus unused medications, as defined, to persons in need of financial assistance to ensure access to necessary pharmaceutical therapies. Existing law requires a county that establishes a depository and redistribution program to develop written procedures for, among other things, establishing eligibility for medically indigent patients who may participate in the program, and ensuring that patients eligible for the program are not charged for any medications provided under the program. Existing law also prohibits the donation of controlled substances to the repository and distribution program. Under existing law, only medication that is donated in unopened, tamper-evident packaging or modified unit dose containers that meet the United States Pharmacopoeia standards, and that includes lot numbers and expiration dates, is eligible for donation to the program. Existing law authorizes a county-owned pharmacy participating in the program to transfer eligible donated medication to a county-owned pharmacy participating in the program within another adjacent county, as specified. Existing law prohibits medication that does not meet the requirements for donation and distribution from being sold, dispensed, or otherwise transferred to any other entity. Existing law requires medication donated to the repository and distribution program to be maintained in the donated packaging units.
This bill would define tamper-evident packaging for purposes of the program. The bill would require a county that establishes a medication repository and donation program to develop written procedures ensuring that manufacturer recalls are handled appropriately for medications with and without lot numbers. The bill would delete the requirement that a donated medication container have a lot number. The bill would authorize a county-owned pharmacy participating in the medication repository and distribution program to transfer eligible donated medication to a participating county-owned pharmacy in any other county, as specified. The bill would authorize medication donated to a medication repository and distribution program to be maintained in new, properly labeled containers. The bill would prohibit donated medication from being repackaged more than 2 times. This bill would also make a technical, nonsubstantive change to these provisions.
Existing law authorizes a county to establish a repository and distribution program under which a pharmacy, including a pharmacy that is owned by, or contracts with, the county, may distribute surplus unused medications, as defined, to persons in need of financial assistance to ensure access to necessary pharmaceutical therapies. Under existing law, only medication that is donated in unopened, tamper-evident packaging or modified unit dose containers that meet the United States Pharmacopoeia standards is eligible for donation to the program. Existing law requires a county that establishes a depository and redistribution program to develop written procedures for, among other things, establishing eligibility for medically indigent patients who may participate in the program, and ensuring that patients eligible for the program are not charged for any medications provided under the program. Existing law also prohibits the donation of controlled substances to the repository and distribution program. Under existing law, only medication that is donated in unopened, tamper-evident packaging or modified unit dose containers that meet the United States Pharmacopoeia standards, and that includes lot numbers and expiration dates, is eligible for donation to the program. Existing law authorizes a county-owned pharmacy participating in the program to transfer eligible donated medication to a county-owned pharmacy participating in the program within another adjacent county, as specified. Existing law prohibits medication that does not meet the requirements for donation and distribution from being sold, dispensed, or otherwise transferred to any other entity. Existing law requires medication donated to the repository and distribution program to be maintained in the donated packaging units.
This bill would define tamper-evident packaging for purposes of the program. The bill would require a county that establishes a medication repository and donation program to develop written procedures ensuring that manufacturer recalls are handled appropriately for medications with and without lot numbers. The bill would delete the requirement that a donated medication container have a lot number. The bill would authorize a county-owned pharmacy participating in the medication repository and distribution program to transfer eligible donated medication to a participating county-owned pharmacy in any other county, as specified. The bill would authorize medication donated to a medication repository and distribution program to be maintained in new, properly labeled containers. This bill would also make a technical, nonsubstantive change to these provisions.
Existing law authorizes a county to establish a repository and distribution program under which a pharmacy, including a that is owned by, or contracts with, the county, may distribute surplus unused medications, as defined, to persons in need of financial assistance to ensure access to necessary pharmaceutical therapies. Under existing law, only medication that is donated in unopened, tamper-evident packaging or modified unit dose containers that meet the United States Pharmacopoeia standards is eligible for donation to the program. Existing law also prohibits the donation of controlled substances to the repository and distribution program. Existing law prohibits medication that does not meet the requirements for donation and distribution from being sold, dispensed, or otherwise transferred to any other entity.
This bill would make a technical, nonsubstantive change to these provisions.
(a)(1)A county may establish, by an action of the county board of supervisors or by an action of the public health officer of the county, as directed by the county board of supervisors, a repository and distribution program for purposes of this division. The county shall advise the California State Board of Pharmacy within 30 days from the date it establishes a repository and distribution program.
(2)Only an eligible entity, pursuant to Section 150201, may participate in this program to dispense medication donated to the drug repository and distribution program.
(3)An eligible entity that seeks to participate in the program shall inform the county health department and the California State Board of Pharmacy in writing of its intent to participate in the program. An eligible entity may not participate in the program until it has received written or electronic documentation from the county health department confirming that the department has received its notice of intent.
(4)(A)A participating entity shall disclose to the county health department on a quarterly basis the name and location of the source of all donated medication it receives.
(B)A participating primary care clinic, as described in Section 150201, shall disclose to the county health department the name of the licensed physician who shall be accountable to the California State Board of Pharmacy for the clinics program operations pursuant to this division. This physician shall be the professional director, as defined in subdivision (c) of Section 4182 of the Business and Professions Code.
(C)The county board of supervisors or public health officer of the county shall, upon request, make available to the California State Board of Pharmacy the information in this division.
(5)The county board of supervisors, the public health officer of the county, and the California State Board of Pharmacy may prohibit an eligible or participating entity from participating in the program if the entity does not comply with the provisions of the program, pursuant to this division. If the county board of supervisors, the public health officer of the county, or the California State Board of Pharmacy prohibits an eligible or participating entity from participating in the program, it shall provide written notice to the prohibited entity within 15 days of making this determination. The county board of supervisors, the public health officer of the county, and the California State Board of Pharmacy shall ensure that this notice also is provided to one another.
(b)A county that elects to establish a repository and distribution program pursuant to this division shall establish written procedures for, at a minimum, all of the following:
(1)Establishing eligibility for medically indigent patients who may participate in the program.
(2)Ensuring that patients eligible for the program shall not be charged for any medications provided under the program.
(3)Developing a formulary of medications appropriate for the repository and distribution program.
(4)Ensuring proper safety and management of any medications collected by and maintained under the authority of a participating entity.
(5)Ensuring the privacy of individuals for whom the medication was originally prescribed.
(c)Any medication donated to the repository and distribution program shall comply with the requirements specified in this division. Medication donated to the repository and distribution program shall meet all of the following criteria:
(1)The medication shall not be a controlled substance.
(2)The medication shall not have been adulterated, misbranded, or stored under conditions contrary to standards set by the United States Pharmacopoeia (USP) or the product manufacturer.
(3)The medication shall not have been in the possession of a patient or any individual member of the public, and in the case of medications donated by a health or care facility, as described in Section 150202, shall have been under the control of a staff member of the health or care facility who is licensed in California as a health care professional or has completed, at a minimum, the training requirements specified in Section 1569.69.
(d)(1)Only medication that is donated in unopened, tamper-evident packaging or modified unit dose containers that meet USP standards is eligible for donation to the repository and distribution program, provided lot numbers and expiration dates are affixed. Medication donated in opened containers shall not be dispensed by the repository and distribution program, and once identified, shall be quarantined immediately and handled and disposed of in accordance with the Medical Waste Management Act (Part 14 (commencing with Section 117600) of Division 104).
(2)(A)A medication that is the subject of a United States Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to Section 355-1 of Title 21 of the United States Code shall not be donated if this inventory transfer is prohibited by that strategy, or if the inventory transfer requires prior authorization from the manufacturer of the medication.
(B)A medication that is the subject of a United States Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to Section 355-1 of Title 21 of the United States Code, the donation of which is not prohibited pursuant to subparagraph (A), shall be managed and dispensed according to the requirements of that strategy.
(e)A pharmacist or physician at a participating entity shall use his or her professional judgment in determining whether donated medication meets the standards of this division before accepting or dispensing any medication under the repository and distribution program.
(f)A pharmacist or physician shall adhere to standard pharmacy practices, as required by state and federal law, when dispensing all medications.
(g)Medication that is donated to the repository and distribution program shall be handled in the following ways:
(1)Dispensed to an eligible patient.
(2)Destroyed.
(3)Returned to a reverse distributor or licensed waste hauler.
(4)(A)Transferred to another participating entity within the county to be dispensed to eligible patients pursuant to this division. Notwithstanding this paragraph, a participating county-owned pharmacy may transfer eligible donated medication to a participating county-owned pharmacy within another adjacent county that has adopted a program pursuant to this division, if the pharmacies transferring the medication have a written agreement between the entities that outlines protocols and procedures for safe and appropriate drug transfer that are consistent with this division.
(B)Medication donated under this division shall not be transferred by any participating entity more than once, and after it has been transferred, shall be dispensed to an eligible patient, destroyed, or returned to a reverse distributor or licensed waste hauler.
(C)Medication transferred pursuant to this paragraph shall be transferred with documentation that identifies the drug name, strength, and quantity of the medication, and the donation facility from where the medication originated shall be identified on medication packaging or in accompanying documentation. The document shall include a statement that the medication may not be transferred to another participating entity and must be handled pursuant to subparagraph (B). A copy of this document shall be kept by the participating entity transferring the medication and the participating entity receiving the medication.
(h)Medication that is donated to the repository and distribution program that does not meet the requirements of this division shall not be distributed or transferred under this program and shall be either destroyed or returned to a reverse distributor. Donated medication that does not meet the requirements of this division shall not be sold, dispensed, or otherwise transferred to any other entity.
(i)(1)Except as provided in paragraph (2), medication donated to the repository and distribution program shall be maintained in the donated packaging units until dispensed to an eligible patient under this program, who presents a valid prescription. When dispensed to an eligible patient under this program, the medication shall be in a new and properly labeled container, specific to the eligible patient and ensuring the privacy of the individuals for whom the medication was initially dispensed. Expired medication shall not be dispensed.
(2)A pharmacy that exists solely to operate the repository and distribution program may repackage a reasonable quantity of donated medicine in anticipation of dispensing the medicine to its patient population. The pharmacy shall have repackaging policies and procedures in place for identifying and recalling medications. Medication that is repackaged shall be labeled with the earliest expiration date.
(j)Medication donated to the repository and distribution program shall be segregated from the participating entitys other drug stock by physical means, for purposes including, but not limited to, inventory, accounting, and inspection.
(k)A participating entity shall keep complete records of the acquisition and disposition of medication donated to, and transferred, dispensed, and destroyed under, the repository and distribution program. These records shall be kept separate from the participating entitys other acquisition and disposition records and shall conform to the Pharmacy Law (Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code), including being readily retrievable.
(l)Local and county protocols established pursuant to this division shall conform to the Pharmacy Law regarding packaging, transporting, storing, and dispensing all medications.
(m)County protocols established for packaging, transporting, storing, and dispensing medications that require refrigeration, including, but not limited to, any biological product as defined in Section 351 of the Public Health Service Act (42 U.S.C. Sec. 262), an intravenously injected drug, or an infused drug, shall include specific procedures to ensure that these medications are packaged, transported, stored, and dispensed at appropriate temperatures and in accordance with USP standards and the Pharmacy Law.
(n)Notwithstanding any other provision of law, a participating entity shall follow the same procedural drug pedigree requirements for donated drugs as it would follow for drugs purchased from a wholesaler or directly from a drug manufacturer.
(a)(1)A county may establish, by an action of the county board of supervisors or by an action of the public health officer of the county, as directed by the county board of supervisors, a repository and distribution program for purposes of this division. The county shall advise the California State Board of Pharmacy within 30 days from the date it establishes a repository and distribution program.
(2)Only an eligible entity, pursuant to Section 150201, may participate in this program to dispense medication donated to the drug repository and distribution program.
(3)An eligible entity that seeks to participate in the program shall inform the county health department and the California State Board of Pharmacy in writing of its intent to participate in the program. An eligible entity may not participate in the program until it has received written or electronic documentation from the county health department confirming that the department has received its notice of intent.
(4)(A)A participating entity shall disclose to the county health department on a quarterly basis the name and location of the source of all donated medication it receives.
(B)A participating primary care clinic, as described in Section 150201, shall disclose to the county health department the name of the licensed physician who shall be accountable to the California State Board of Pharmacy for the clinics program operations pursuant to this division. This physician shall be the professional director, as defined in subdivision (c) of Section 4182 of the Business and Professions Code.
(C)The county board of supervisors or public health officer of the county shall, upon request, make available to the California State Board of Pharmacy the information in this division.
(5)The county board of supervisors, the public health officer of the county, and the California State Board of Pharmacy may prohibit an eligible or participating entity from participating in the program if the entity does not comply with the provisions of the program, pursuant to this division. If the county board of supervisors, the public health officer of the county, or the California State Board of Pharmacy prohibits an eligible or participating entity from participating in the program, it shall provide written notice to the prohibited entity within 15 days of making this determination. The county board of supervisors, the public health officer of the county, and the California State Board of Pharmacy shall ensure that this notice also is provided to one another.
(b)A county that elects to establish a repository and distribution program pursuant to this division shall establish written procedures for, at a minimum, all of the following:
(1)Establishing eligibility for medically indigent patients who may participate in the program.
(2)Ensuring that patients eligible for the program shall not be charged for any medications provided under the program.
(3)Developing a formulary of medications appropriate for the repository and distribution program.
(4)Ensuring proper safety and management of any medications collected by and maintained under the authority of a participating entity.
(5)Ensuring the privacy of individuals for whom the medication was originally prescribed.
(c)Any medication donated to the repository and distribution program shall comply with the requirements specified in this division. Medication donated to the repository and distribution program shall meet all of the following criteria:
(1)The medication shall not be a controlled substance.
(2)The medication shall not have been adulterated, misbranded, or stored under conditions contrary to standards set by the United States Pharmacopoeia (USP) or the product manufacturer.
(3)The medication shall not have been in the possession of a patient or any individual member of the public, and in the case of medications donated by a health or care facility, as described in Section 150202, shall have been under the control of a staff member of the health or care facility who is licensed in California as a health care professional or has completed, at a minimum, the training requirements specified in Section 1569.69.
(d)(1)Only medication that is donated in unopened, tamper-evident packaging or modified unit dose containers that meet USP standards is eligible for donation to the repository and distribution program, provided lot numbers and expiration dates are affixed. Medication donated in opened containers shall not be dispensed by the repository and distribution program, and once identified, shall be quarantined immediately and handled and disposed of in accordance with the Medical Waste Management Act (Part 14 (commencing with Section 117600) of Division 104).
(2)(A)A medication that is the subject of a United States Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to Section 355-1 of Title 21 of the United States Code shall not be donated if this inventory transfer is prohibited by that strategy, or if the inventory transfer requires prior authorization from the manufacturer of the medication.
(B)A medication that is the subject of a United States Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to Section 355-1 of Title 21 of the United States Code, the donation of which is not prohibited pursuant to subparagraph (A), shall be managed and dispensed according to the requirements of that strategy.
(e)A pharmacist or physician at a participating entity shall use his or her professional judgment in determining whether donated medication meets the standards of this division before accepting or dispensing any medication under the repository and distribution program.
(f)A pharmacist or physician shall adhere to standard pharmacy practices, as required by state and federal law, when dispensing all medications.
(g)Medication that is donated to the repository and distribution program shall be handled in the following ways:
(1)Dispensed to an eligible patient.
(2)Destroyed.
(3)Returned to a reverse distributor or licensed waste hauler.
(4)(A)Transferred to another participating entity within the county to be dispensed to eligible patients pursuant to this division. Notwithstanding this paragraph, a participating county-owned pharmacy may transfer eligible donated medication to a participating county-owned pharmacy within another adjacent county that has adopted a program pursuant to this division, if the pharmacies transferring the medication have a written agreement between the entities that outlines protocols and procedures for safe and appropriate drug transfer that are consistent with this division.
(B)Medication donated under this division shall not be transferred by any participating entity more than once, and after it has been transferred, shall be dispensed to an eligible patient, destroyed, or returned to a reverse distributor or licensed waste hauler.
(C)Medication transferred pursuant to this paragraph shall be transferred with documentation that identifies the drug name, strength, and quantity of the medication, and the donation facility from where the medication originated shall be identified on medication packaging or in accompanying documentation. The document shall include a statement that the medication may not be transferred to another participating entity and must be handled pursuant to subparagraph (B). A copy of this document shall be kept by the participating entity transferring the medication and the participating entity receiving the medication.
(h)Medication that is donated to the repository and distribution program that does not meet the requirements of this division shall not be distributed or transferred under this program and shall be either destroyed or returned to a reverse distributor. Donated medication that does not meet the requirements of this division shall not be sold, dispensed, or otherwise transferred to any other entity.
(i)(1)Except as provided in paragraph (2), medication donated to the repository and distribution program shall be maintained in the donated packaging units until dispensed to an eligible patient under this program, who presents a valid prescription. When dispensed to an eligible patient under this program, the medication shall be in a new and properly labeled container, specific to the eligible patient and ensuring the privacy of the individuals for whom the medication was initially dispensed. Expired medication shall not be dispensed.
(2)A pharmacy that exists solely to operate the repository and distribution program may repackage a reasonable quantity of donated medicine in anticipation of dispensing the medicine to its patient population. The pharmacy shall have repackaging policies and procedures in place for identifying and recalling medications. Medication that is repackaged shall be labeled with the earliest expiration date.
(j)Medication donated to the repository and distribution program shall be segregated from the participating entitys other drug stock by physical means, for purposes including, but not limited to, inventory, accounting, and inspection.
(k)A participating entity shall keep complete records of the acquisition and disposition of medication donated to, and transferred, dispensed, and destroyed under, the repository and distribution program. These records shall be kept separate from the participating entitys other acquisition and disposition records and shall conform to the Pharmacy Law (Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code), including being readily retrievable.
(l)Local and county protocols established pursuant to this division shall conform to the Pharmacy Law regarding packaging, transporting, storing, and dispensing all medications.
(m)County protocols established for packaging, transporting, storing, and dispensing medications that require refrigeration, including, but not limited to, any biological product as defined in Section 351 of the Public Health Service Act (42 U.S.C. Sec. 262), an intravenously injected drug, or an infused drug, shall include specific procedures to ensure that these medications are packaged, transported, stored, and dispensed at appropriate temperatures and in accordance with USP standards and the Pharmacy Law.
(n)Notwithstanding any other provision of law, a participating entity shall follow the same procedural drug pedigree requirements for donated drugs as it would follow for drugs purchased from a wholesaler or directly from a drug manufacturer.
(a)(1)A county may establish, by an action of the county board of supervisors or by an action of the public health officer of the county, as directed by the county board of supervisors, a repository and distribution program for purposes of this division. The county shall advise the California State Board of Pharmacy within 30 days from the date it establishes a repository and distribution program.
(2)Only an eligible entity, pursuant to Section 150201, may participate in this program to dispense medication donated to the drug repository and distribution program.
(3)An eligible entity that seeks to participate in the program shall inform the county health department and the California State Board of Pharmacy in writing of its intent to participate in the program. An eligible entity may not participate in the program until it has received written or electronic documentation from the county health department confirming that the department has received its notice of intent.
(4)(A)A participating entity shall disclose to the county health department on a quarterly basis the name and location of the source of all donated medication it receives.
(B)A participating primary care clinic, as described in Section 150201, shall disclose to the county health department the name of the licensed physician who shall be accountable to the California State Board of Pharmacy for the clinics program operations pursuant to this division. This physician shall be the professional director, as defined in subdivision (c) of Section 4182 of the Business and Professions Code.
(C)The county board of supervisors or public health officer of the county shall, upon request, make available to the California State Board of Pharmacy the information in this division.
(5)The county board of supervisors, the public health officer of the county, and the California State Board of Pharmacy may prohibit an eligible or participating entity from participating in the program if the entity does not comply with the provisions of the program, pursuant to this division. If the county board of supervisors, the public health officer of the county, or the California State Board of Pharmacy prohibits an eligible or participating entity from participating in the program, it shall provide written notice to the prohibited entity within 15 days of making this determination. The county board of supervisors, the public health officer of the county, and the California State Board of Pharmacy shall ensure that this notice also is provided to one another.
(b)A county that elects to establish a repository and distribution program pursuant to this division shall establish written procedures for, at a minimum, all of the following:
(1)Establishing eligibility for medically indigent patients who may participate in the program.
(2)Ensuring that patients eligible for the program shall not be charged for any medications provided under the program.
(3)Developing a formulary of medications appropriate for the repository and distribution program.
(4)Ensuring proper safety and management of any medications collected by and maintained under the authority of a participating entity.
(5)Ensuring the privacy of individuals for whom the medication was originally prescribed.
(c)Any medication donated to the repository and distribution program shall comply with the requirements specified in this division. Medication donated to the repository and distribution program shall meet all of the following criteria:
(1)The medication shall not be a controlled substance.
(2)The medication shall not have been adulterated, misbranded, or stored under conditions contrary to standards set by the United States Pharmacopoeia (USP) or the product manufacturer.
(3)The medication shall not have been in the possession of a patient or any individual member of the public, and in the case of medications donated by a health or care facility, as described in Section 150202, shall have been under the control of a staff member of the health or care facility who is licensed in California as a health care professional or has completed, at a minimum, the training requirements specified in Section 1569.69.
(d)(1)Only medication that is donated in unopened, tamper-evident packaging or modified unit dose containers that meet USP standards is eligible for donation to the repository and distribution program, provided lot numbers and expiration dates are affixed. Medication donated in opened containers shall not be dispensed by the repository and distribution program, and once identified, shall be quarantined immediately and handled and disposed of in accordance with the Medical Waste Management Act (Part 14 (commencing with Section 117600) of Division 104).
(2)(A)A medication that is the subject of a United States Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to Section 355-1 of Title 21 of the United States Code shall not be donated if this inventory transfer is prohibited by that strategy, or if the inventory transfer requires prior authorization from the manufacturer of the medication.
(B)A medication that is the subject of a United States Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to Section 355-1 of Title 21 of the United States Code, the donation of which is not prohibited pursuant to subparagraph (A), shall be managed and dispensed according to the requirements of that strategy.
(e)A pharmacist or physician at a participating entity shall use his or her professional judgment in determining whether donated medication meets the standards of this division before accepting or dispensing any medication under the repository and distribution program.
(f)A pharmacist or physician shall adhere to standard pharmacy practices, as required by state and federal law, when dispensing all medications.
(g)Medication that is donated to the repository and distribution program shall be handled in the following ways:
(1)Dispensed to an eligible patient.
(2)Destroyed.
(3)Returned to a reverse distributor or licensed waste hauler.
(4)(A)Transferred to another participating entity within the county to be dispensed to eligible patients pursuant to this division. Notwithstanding this paragraph, a participating county-owned pharmacy may transfer eligible donated medication to a participating county-owned pharmacy within another adjacent county that has adopted a program pursuant to this division, if the pharmacies transferring the medication have a written agreement between the entities that outlines protocols and procedures for safe and appropriate drug transfer that are consistent with this division.
(B)Medication donated under this division shall not be transferred by any participating entity more than once, and after it has been transferred, shall be dispensed to an eligible patient, destroyed, or returned to a reverse distributor or licensed waste hauler.
(C)Medication transferred pursuant to this paragraph shall be transferred with documentation that identifies the drug name, strength, and quantity of the medication, and the donation facility from where the medication originated shall be identified on medication packaging or in accompanying documentation. The document shall include a statement that the medication may not be transferred to another participating entity and must be handled pursuant to subparagraph (B). A copy of this document shall be kept by the participating entity transferring the medication and the participating entity receiving the medication.
(h)Medication that is donated to the repository and distribution program that does not meet the requirements of this division shall not be distributed or transferred under this program and shall be either destroyed or returned to a reverse distributor. Donated medication that does not meet the requirements of this division shall not be sold, dispensed, or otherwise transferred to any other entity.
(i)(1)Except as provided in paragraph (2), medication donated to the repository and distribution program shall be maintained in the donated packaging units until dispensed to an eligible patient under this program, who presents a valid prescription. When dispensed to an eligible patient under this program, the medication shall be in a new and properly labeled container, specific to the eligible patient and ensuring the privacy of the individuals for whom the medication was initially dispensed. Expired medication shall not be dispensed.
(2)A pharmacy that exists solely to operate the repository and distribution program may repackage a reasonable quantity of donated medicine in anticipation of dispensing the medicine to its patient population. The pharmacy shall have repackaging policies and procedures in place for identifying and recalling medications. Medication that is repackaged shall be labeled with the earliest expiration date.
(j)Medication donated to the repository and distribution program shall be segregated from the participating entitys other drug stock by physical means, for purposes including, but not limited to, inventory, accounting, and inspection.
(k)A participating entity shall keep complete records of the acquisition and disposition of medication donated to, and transferred, dispensed, and destroyed under, the repository and distribution program. These records shall be kept separate from the participating entitys other acquisition and disposition records and shall conform to the Pharmacy Law (Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code), including being readily retrievable.
(l)Local and county protocols established pursuant to this division shall conform to the Pharmacy Law regarding packaging, transporting, storing, and dispensing all medications.
(m)County protocols established for packaging, transporting, storing, and dispensing medications that require refrigeration, including, but not limited to, any biological product as defined in Section 351 of the Public Health Service Act (42 U.S.C. Sec. 262), an intravenously injected drug, or an infused drug, shall include specific procedures to ensure that these medications are packaged, transported, stored, and dispensed at appropriate temperatures and in accordance with USP standards and the Pharmacy Law.
(n)Notwithstanding any other provision of law, a participating entity shall follow the same procedural drug pedigree requirements for donated drugs as it would follow for drugs purchased from a wholesaler or directly from a drug manufacturer.
(a)(1)A county may establish, by an action of the county board of supervisors or by an action of the public health officer of the county, as directed by the county board of supervisors, a repository and distribution program for purposes of this division. The county shall advise the California State Board of Pharmacy within 30 days from the date it establishes a repository and distribution program.
(2)Only an eligible entity, pursuant to Section 150201, may participate in this program to dispense medication donated to the drug repository and distribution program.
(3)An eligible entity that seeks to participate in the program shall inform the county health department and the California State Board of Pharmacy in writing of its intent to participate in the program. An eligible entity may not participate in the program until it has received written or electronic documentation from the county health department confirming that the department has received its notice of intent.
(4)(A)A participating entity shall disclose to the county health department on a quarterly basis the name and location of the source of all donated medication it receives.
(B)A participating primary care clinic, as described in Section 150201, shall disclose to the county health department the name of the licensed physician who shall be accountable to the California State Board of Pharmacy for the clinics program operations pursuant to this division. This physician shall be the professional director, as defined in subdivision (c) of Section 4182 of the Business and Professions Code.
(C)The county board of supervisors or public health officer of the county shall, upon request, make available to the California State Board of Pharmacy the information in this division.
(5)The county board of supervisors, the public health officer of the county, and the California State Board of Pharmacy may prohibit an eligible or participating entity from participating in the program if the entity does not comply with the provisions of the program, pursuant to this division. If the county board of supervisors, the public health officer of the county, or the California State Board of Pharmacy prohibits an eligible or participating entity from participating in the program, it shall provide written notice to the prohibited entity within 15 days of making this determination. The county board of supervisors, the public health officer of the county, and the California State Board of Pharmacy shall ensure that this notice also is provided to one another.
(b)A county that elects to establish a repository and distribution program pursuant to this division shall establish written procedures for, at a minimum, all of the following:
(1)Establishing eligibility for medically indigent patients who may participate in the program.
(2)Ensuring that patients eligible for the program shall not be charged for any medications provided under the program.
(3)Developing a formulary of medications appropriate for the repository and distribution program.
(4)Ensuring proper safety and management of any medications collected by and maintained under the authority of a participating entity.
(5)Ensuring the privacy of individuals for whom the medication was originally prescribed.
(c)Any medication donated to the repository and distribution program shall comply with the requirements specified in this division. Medication donated to the repository and distribution program shall meet all of the following criteria:
(1)The medication shall not be a controlled substance.
(2)The medication shall not have been adulterated, misbranded, or stored under conditions contrary to standards set by the United States Pharmacopoeia (USP) or the product manufacturer.
(3)The medication shall not have been in the possession of a patient or any individual member of the public, and in the case of medications donated by a health or care facility, as described in Section 150202, shall have been under the control of a staff member of the health or care facility who is licensed in California as a health care professional or has completed, at a minimum, the training requirements specified in Section 1569.69.
(d)(1)Only medication that is donated in unopened, tamper-evident packaging or modified unit dose containers that meet USP standards is eligible for donation to the repository and distribution program, provided lot numbers and expiration dates are affixed. Medication donated in opened containers shall not be dispensed by the repository and distribution program, and once identified, shall be quarantined immediately and handled and disposed of in accordance with the Medical Waste Management Act (Part 14 (commencing with Section 117600) of Division 104).
(2)(A)A medication that is the subject of a United States Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to Section 355-1 of Title 21 of the United States Code shall not be donated if this inventory transfer is prohibited by that strategy, or if the inventory transfer requires prior authorization from the manufacturer of the medication.
(B)A medication that is the subject of a United States Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to Section 355-1 of Title 21 of the United States Code, the donation of which is not prohibited pursuant to subparagraph (A), shall be managed and dispensed according to the requirements of that strategy.
(e)A pharmacist or physician at a participating entity shall use his or her professional judgment in determining whether donated medication meets the standards of this division before accepting or dispensing any medication under the repository and distribution program.
(f)A pharmacist or physician shall adhere to standard pharmacy practices, as required by state and federal law, when dispensing all medications.
(g)Medication that is donated to the repository and distribution program shall be handled in the following ways:
(1)Dispensed to an eligible patient.
(2)Destroyed.
(3)Returned to a reverse distributor or licensed waste hauler.
(4)(A)Transferred to another participating entity within the county to be dispensed to eligible patients pursuant to this division. Notwithstanding this paragraph, a participating entity may transfer eligible donated medication to a participating entity within another county that has adopted a program pursuant to this division, if the participating entities transferring the medication have a written agreement that outlines protocols and procedures for safe and appropriate drug transfer that are consistent with this division. A participating entity shall not transfer more than 15 percent of its donated medications annually unless the transfer is performed pursuant to Section 4126.5 of the Business and Professions Code.
(4)(A)Transferred to another participating entity within the county to be dispensed to eligible patients pursuant to this division. Notwithstanding this paragraph, a participating county-owned pharmacy may transfer eligible donated medication to a participating county-owned pharmacy within another adjacent county that has adopted a program pursuant to this division, if the pharmacies transferring the medication have a written agreement between the entities that outlines protocols and procedures for safe and appropriate drug transfer that are consistent with this division.
(B)Medication donated under this division shall not be transferred by any participating entity more than once, and after it has been transferred, shall be dispensed to an eligible patient, destroyed, or returned to a reverse distributor or licensed waste hauler.
(C)Medication transferred pursuant to this paragraph shall be transferred with documentation that identifies the drug name, strength, and quantity of the medication, and the donation facility from where the medication originated shall be identified on medication packaging or in accompanying documentation. The document shall include a statement that the medication may not be transferred to another participating entity and must be handled pursuant to subparagraph (B). A copy of this document shall be kept by the participating entity transferring the medication and the participating entity receiving the medication.
(h)Medication that is donated to the repository and distribution program that does not meet the requirements of this division shall not be distributed or transferred under this program and shall be either destroyed or returned to a reverse distributor. Donated medication that does not meet the requirements of this division shall not be sold, dispensed, or otherwise transferred to any other entity.
(i)(1)Medication Except as provided in paragraph (2), medication donated to the repository and distribution program shall be maintained in the donated packaging units or new, properly labeled containers until dispensed to an eligible patient under this program, who presents a valid prescription. When dispensed to an eligible patient under this program, the medication shall be in a new and properly labeled container, specific to the eligible patient and ensuring the privacy of the individuals for whom the medication was initially dispensed. Expired medication shall not be dispensed. Donated medication shall not be repackaged more than two times. Nothing in this section requires donated medication to be repackaged two times.
(2)All of the following requirements shall be satisfied when repackaging donated medication:
(A)Medication shall be repackaged into a container that holds an individual prescription for a supply of no more than 90 days.
(B)Repackaged medication shall be identifiable as donated medication.
(C)Repackaged medication shall be labeled with all of the following:
(i)All applicable lot numbers.
(ii)The earliest expiration date.
(iii)The number of times that the medication has been repackaged.
(2)A pharmacy that exists solely to operate the repository and distribution program may repackage a reasonable quantity of donated medicine in anticipation of dispensing the medicine to its patient population. The pharmacy shall have repackaging policies and procedures in place for identifying and recalling medications.
(j)Medication donated to the repository and distribution program shall be segregated from the participating entitys other drug stock by physical means, for purposes including, but not limited to, inventory, accounting, and inspection.
(k)A participating entity shall keep complete records of the acquisition and disposition of medication donated to, and transferred, dispensed, and destroyed under, the repository and distribution program. These records shall be kept separate from the participating entitys other acquisition and disposition records and shall conform to the Pharmacy Law (Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code), including being readily retrievable.
(l)Local and county protocols established pursuant to this division shall conform to the Pharmacy Law regarding packaging, transporting, storing, and dispensing all medications.
(m)County protocols established for packaging, transporting, storing, and dispensing medications that require refrigeration, including, but not limited to, any biological product as defined in Section 351 of the Public Health Service Act (42 U.S.C. Sec. 262), an intravenously injected drug, or an infused drug, shall include specific procedures to ensure that these medications are packaged, transported, stored, and dispensed at appropriate temperatures and in accordance with USP standards and the Pharmacy Law.
(n)Notwithstanding any other provision of law, a participating entity shall follow the same procedural drug pedigree requirements for donated drugs as it would follow for drugs purchased from a wholesaler or directly from a drug manufacturer.
(a)(1)A county may establish, by an action of the county board of supervisors or by an action of the public health officer of the county, as directed by the county board of supervisors, a repository and distribution program for purposes of this division. The county shall advise the California State Board of Pharmacy within 30 days from the date it establishes a repository and distribution program.
(2)Only an eligible entity, pursuant to Section 150201, may participate in this program to dispense medication donated to the drug repository and distribution program.
(3)An eligible entity that seeks to participate in the program shall inform the county health department and the California State Board of Pharmacy in writing of its intent to participate in the program. An eligible entity may not participate in the program until it has received written or electronic documentation from the county health department confirming that the department has received its notice of intent.
(4)(A)A participating entity shall disclose to the county health department on a quarterly basis the name and location of the source of all donated medication it receives.
(B)A participating primary care clinic, as described in Section 150201, shall disclose to the county health department the name of the licensed physician who shall be accountable to the California State Board of Pharmacy for the clinics program operations pursuant to this division. This physician shall be the professional director, as defined in subdivision (c) of Section 4182 of the Business and Professions Code.
(C)The county board of supervisors or public health officer of the county shall, upon request, make available to the California State Board of Pharmacy the information in this division.
(5)The county board of supervisors, the public health officer of the county, and the California State Board of Pharmacy may prohibit an eligible or participating entity from participating in the program if the entity does not comply with the provisions of the program, pursuant to this division. If the county board of supervisors, the public health officer of the county, or the California State Board of Pharmacy prohibits an eligible or participating entity from participating in the program, it shall provide written notice to the prohibited entity within 15 days of making this determination. The county board of supervisors, the public health officer of the county, and the California State Board of Pharmacy shall ensure that this notice also is provided to one another.
(b)A county that elects to establish a repository and distribution program pursuant to this division shall establish written procedures for, at a minimum, all of the following:
(1)Establishing eligibility for medically indigent patients who may participate in the program.
(2)Ensuring that patients eligible for the program shall not be charged for any medications provided under the program.
(3)Developing a formulary of medications appropriate for the repository and distribution program.
(4)Ensuring proper safety and management of any medications collected by and maintained under the authority of a participating entity.
(5)Ensuring the privacy of individuals for whom the medication was originally prescribed.
(c)Any medication donated to the repository and distribution program shall comply with the requirements specified in this division. Medication donated to the repository and distribution program shall meet all of the following criteria:
(1)The medication shall not be a controlled substance.
(2)The medication shall not have been adulterated, misbranded, or stored under conditions contrary to standards set by the United States Pharmacopoeia (USP) or the product manufacturer.
(3) The medication shall not have been in the possession of a patient or any individual member of the public, and in the case of medications donated by a health or care facility, as described in Section 150202, shall have been under the control of a staff member of the health or care facility who is licensed in California as a health care professional or has completed, at a minimum, the training requirements specified in Section 1569.69.
(d)(1)Only medication that is donated in unopened, tamper-evident packaging or modified unit dose containers that meet USP standards is eligible for donation to the repository and distribution program, provided lot numbers and expiration dates are affixed. Medication donated in opened containers shall not be dispensed by the repository and distribution program, and once identified, shall be quarantined immediately and handled and disposed of in accordance with the Medical Waste Management Act (Part 14 (commencing with Section 117600) of Division 104).
(2)(A)A medication that is the subject of a United States Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to Section 355-1 of Title 21 of the United States Code shall not be donated if this inventory transfer is prohibited by that strategy, or if the inventory transfer requires prior authorization from the manufacturer of the medication.
(B)A medication that is the subject of a United States Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to Section 355-1 of Title 21 of the United States Code, the donation of which is not prohibited pursuant to subparagraph (A), shall be managed and dispensed according to the requirements of that strategy.
(e)A pharmacist or physician at a participating entity shall use his or her professional judgment in determining whether donated medication meets the standards of this division before accepting or dispensing any medication under the repository and distribution program.
(f)A pharmacist or physician shall adhere to standard pharmacy practices, as required by state and federal law, when dispensing all medications.
(g)Medication that is donated to the repository and distribution program shall be handled in the following ways:
(1)Dispensed to an eligible patient.
(2)Destroyed.
(3)Returned to a reverse distributor or licensed waste hauler.
(4)(A)Transferred to another participating entity within the county to be dispensed to eligible patients pursuant to this division. Notwithstanding this paragraph, a participating county-owned pharmacy entity may transfer eligible donated medication to a participating county-owned pharmacy entity within another county that has adopted a program pursuant to this division, if the pharmacies participating entities transferring the medication have a written agreement between the entities that outlines protocols and procedures for safe and appropriate drug transfer that are consistent with this division. A participating entity shall not transfer more than 15 percent of its donated medications annually unless the transfer is performed pursuant to Section 4126.5 of the Business and Professions Code.
(B)Medication donated under this division shall not be transferred by any participating entity more than once, and after it has been transferred, shall be dispensed to an eligible patient, destroyed, or returned to a reverse distributor or licensed waste hauler.
(C)Medication transferred pursuant to this paragraph shall be transferred with documentation that identifies the drug name, strength, and quantity of the medication, and the donation facility from where the medication originated shall be identified on medication packaging or in accompanying documentation. The document shall include a statement that the medication may not be transferred to another participating entity and must be handled pursuant to subparagraph (B). A copy of this document shall be kept by the participating entity transferring the medication and the participating entity receiving the medication.
(h)Medication that is donated to the repository and distribution program that does not meet the requirements of this division shall not be distributed or transferred under this program and shall be either destroyed or returned to a reverse distributor. Donated medication that does not meet the requirements of this division shall not be sold, dispensed, or otherwise transferred to any other entity.
(i)(1)Medication donated to the repository and distribution program shall be maintained in the donated packaging units or new, properly labeled containers until dispensed to an eligible patient under this program, who presents a valid prescription. When dispensed to an eligible patient under this program, the medication shall be in a new and properly labeled container, specific to the eligible patient and ensuring the privacy of the individuals for whom the medication was initially dispensed. Expired medication shall not be dispensed. Donated medication shall not be repackaged more than two times. Nothing in this section requires donated medication to be repackaged two times.
(2)All of the following requirements shall be satisfied when repackaging donated medication:
(A)Medication shall be repackaged into a container that holds an individual prescription for a supply of no more than 90 days.
(B)Repackaged medication shall be identifiable as donated medication.
(C)Repackaged medication shall be labeled with all of the following:
(i)All applicable lot numbers.
(ii)The earliest expiration date.
(iii)The number of times that the medication has been repackaged.
(j)Medication donated to the repository and distribution program shall be segregated from the participating entitys other drug stock by physical means, for purposes including, but not limited to, inventory, accounting, and inspection.
(k)A participating entity shall keep complete records of the acquisition and disposition of medication donated to, and transferred, dispensed, and destroyed under, the repository and distribution program. These records shall be kept separate from the participating entitys other acquisition and disposition records and shall conform to the Pharmacy Law (Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code), including being readily retrievable.
(l)Local and county protocols established pursuant to this division shall conform to the Pharmacy Law regarding packaging, transporting, storing, and dispensing all medications.
(m)County protocols established for packaging, transporting, storing, and dispensing medications that require refrigeration, including, but not limited to, any biological product as defined in Section 351 of the Public Health Service Act (42 U.S.C. Sec. 262), an intravenously injected drug, or an infused drug, shall include specific procedures to ensure that these medications are packaged, transported, stored, and dispensed at appropriate temperatures and in accordance with USP standards and the Pharmacy Law.
(n)Notwithstanding any other provision of law, a participating entity shall follow the same procedural drug pedigree requirements for donated drugs as it would follow for drugs purchased from a wholesaler or directly from a drug manufacturer.
For purposes of this division:
(a)Donor organization means an entity described in subdivision (a) of Section 150202.
(b)Eligible entity means all of the following:
(1)A licensed pharmacy, as defined in subdivision (a) of Section 4037 of the Business and Professions Code, that is county owned or that contracts with the county pursuant to this division and is not on probation with the California State Board of Pharmacy.
(2)A licensed pharmacy, as defined in subdivision (a) of Section 4037 of the Business and Professions Code, that is owned and operated by a primary care clinic, as defined in Section 1204, that is licensed by the State Department of Public Health and is not on probation with the California State Board of Pharmacy.
(3)A primary care clinic, as defined in Section 1204, that is licensed by the State Department of Public Health and licensed to administer and dispense drugs pursuant to subparagraph (A) of paragraph (1) of subdivision (a) of Section 4180 of the Business and Professions Code and is not on probation with the California State Board of Pharmacy.
(c)Medication or medications means a dangerous drug, as defined in Section 4022 of the Business and Professions Code.
(d)Participating entity means an eligible entity that has received written or electronic documentation from the county health department pursuant to paragraph (3) of subdivision (a) of Section 150204 and that operates a repository and distribution program pursuant to this division.
(e)Tamper-evident packaging means an immediate, outer, or secondary container that is sealed by an organization eligible to donate medication pursuant to this division and that has a seal that must be broken in order to gain access to the containers medication.
SEC. 2.SECTION 1.Section 150204 of the Health and Safety Code is amended to read:150204.(a)(1)A county may establish, by an action of the county board of supervisors or by an action of the public health officer of the county, as directed by the county board of supervisors, a repository and distribution program for purposes of this division. The county shall advise the California State Board of Pharmacy within 30 days from the date it establishes a repository and distribution program.
(2)Only an eligible entity, pursuant to Section 150201, may participate in this program to dispense medication donated to the drug repository and distribution program.
(3)An eligible entity that seeks to participate in the program shall inform the county health department and the California State Board of Pharmacy in writing of its intent to participate in the program. An eligible entity may not participate in the program until it has received written or electronic documentation from the county health department confirming that the department has received its notice of intent.
(4)(A)A participating entity shall disclose to the county health department on a quarterly basis the name and location of the source of all donated medication it receives.
(B)A participating primary care clinic, as described in Section 150201, shall disclose to the county health department the name of the licensed physician who shall be accountable to the California State Board of Pharmacy for the clinics program operations pursuant to this division. This physician shall be the professional director, as defined in subdivision (c) of Section 4182 of the Business and Professions Code.
(C)The county board of supervisors or public health officer of the county shall, upon request, make available to the California State Board of Pharmacy the information in this division.
(5)The county board of supervisors, the public health officer of the county, and the California State Board of Pharmacy may prohibit an eligible or participating entity from participating in the program if the entity does not comply with the provisions of the program, pursuant to this division. If the county board of supervisors, the public health officer of the county, or the California State Board of Pharmacy prohibits an eligible or participating entity from participating in the program, it shall provide written notice to the prohibited entity within 15 days of making this determination. The county board of supervisors, the public health officer of the county, and the California State Board of Pharmacy shall ensure that this notice also is provided to one another.
(b)A county that elects to establish a repository and distribution program pursuant to this division shall establish written procedures for, at a minimum, all of the following:
(1)Establishing eligibility for medically indigent patients who may participate in the program.
(2)Ensuring that patients eligible for the program shall not be charged for any medications provided under the program.
(3)Developing a formulary of medications appropriate for the repository and distribution program.
(4)Ensuring proper safety and management of any medications collected by and maintained under the authority of a participating entity.
(5)Ensuring the privacy of individuals for whom the medication was originally prescribed.
(6)Ensuring manufacturer recalls are handled appropriately for medications with and without lot numbers.
(c)Any medication donated to the repository and distribution program shall comply with the requirements specified in this division. Medication donated to the repository and distribution program shall meet all of the following criteria:
(1)The medication shall not be a controlled substance.
(2)The medication shall not have been adulterated, misbranded, or stored under conditions contrary to standards set by the United States Pharmacopoeia (USP) or the product manufacturer.
(3) The medication shall not have been in the possession of a patient or any individual member of the public, and in the case of medications donated by a health or care facility, as described in Section 150202, shall have been under the control of a staff member of the health or care facility who is licensed in California as a health care professional or has completed, at a minimum, the training requirements specified in Section 1569.69.
(d)(1)Only medication that is donated in unopened, tamper-evident packaging or modified unit dose containers that meet USP standards is eligible for donation to the repository and distribution program, provided lot numbers and expiration dates are affixed. Medication donated in opened containers shall not be dispensed by the repository and distribution program, and once identified, shall be quarantined immediately and handled and disposed of in accordance with the Medical Waste Management Act (Part 14 (commencing with Section 117600) of Division 104).
(2)(A)A medication that is the subject of a United States Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to Section 355-1 of Title 21 of the United States Code shall not be donated if this inventory transfer is prohibited by that strategy, or if the inventory transfer requires prior authorization from the manufacturer of the medication.
(B)A medication that is the subject of a United States Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to Section 355-1 of Title 21 of the United States Code, the donation of which is not prohibited pursuant to subparagraph (A), shall be managed and dispensed according to the requirements of that strategy.
(e)A pharmacist or physician at a participating entity shall use his or her professional judgment in determining whether donated medication meets the standards of this division before accepting or dispensing any medication under the repository and distribution program.
(f)A pharmacist or physician shall adhere to standard pharmacy practices, as required by state and federal law, when dispensing all medications.
(g)Medication that is donated to the repository and distribution program shall be handled in the following ways:
(1)Dispensed to an eligible patient.
(2)Destroyed.
(3)Returned to a reverse distributor or licensed waste hauler.
(4)(A)Transferred to another participating entity within the county to be dispensed to eligible patients pursuant to this division. Notwithstanding this paragraph, a participating county-owned pharmacy may transfer eligible donated medication to a participating county-owned pharmacy within another county that has adopted a program pursuant to this division, if the pharmacies transferring the medication have a written agreement between the entities that outlines protocols and procedures for safe and appropriate drug transfer that are consistent with this division.
(B)Medication donated under this division shall not be transferred by any participating entity more than once, and after it has been transferred, shall be dispensed to an eligible patient, destroyed, or returned to a reverse distributor or licensed waste hauler.
(C)Medication transferred pursuant to this paragraph shall be transferred with documentation that identifies the drug name, strength, and quantity of the medication, and the donation facility from where the medication originated shall be identified on medication packaging or in accompanying documentation. The document shall include a statement that the medication may not be transferred to another participating entity and must be handled pursuant to subparagraph (B). A copy of this document shall be kept by the participating entity transferring the medication and the participating entity receiving the medication.
(h)Medication that is donated to the repository and distribution program that does not meet the requirements of this division shall not be distributed or transferred under this program and shall be either destroyed or returned to a reverse distributor. Donated medication that does not meet the requirements of this division shall not be sold, dispensed, or otherwise transferred to any other entity.
(i)Medication donated to the repository and distribution program shall be maintained in the donated packaging units or new, properly labeled containers until dispensed to an eligible patient under this program, who presents a valid prescription. When dispensed to an eligible patient under this program, the medication shall be in a new and properly labeled container, specific to the eligible patient and ensuring the privacy of the individuals for whom the medication was initially dispensed. Expired medication shall not be dispensed. Donated medication shall not be repackaged more than two times. Nothing in this section requires donated medication to be repackaged two times.
(j)Medication donated to the repository and distribution program shall be segregated from the participating entitys other drug stock by physical means, for purposes including, but not limited to, inventory, accounting, and inspection.
(k)A participating entity shall keep complete records of the acquisition and disposition of medication donated to, and transferred, dispensed, and destroyed under, the repository and distribution program. These records shall be kept separate from the participating entitys other acquisition and disposition records and shall conform to the Pharmacy Law (Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code), including being readily retrievable.
(l)Local and county protocols established pursuant to this division shall conform to the Pharmacy Law regarding packaging, transporting, storing, and dispensing all medications.
(m)County protocols established for packaging, transporting, storing, and dispensing medications that require refrigeration, including, but not limited to, any biological product as defined in Section 351 of the Public Health Service Act (42 U.S.C. Sec. 262), an intravenously injected drug, or an infused drug, shall include specific procedures to ensure that these medications are packaged, transported, stored, and dispensed at appropriate temperatures and in accordance with USP standards and the Pharmacy Law.
(n)Notwithstanding any other provision of law, a participating entity shall follow the same procedural drug pedigree requirements for donated drugs as it would follow for drugs purchased from a wholesaler or directly from a drug manufacturer.
For purposes of this division:
(a)Donor organization means an entity described in subdivision (a) of Section 150202.
(b)Eligible entity means all of the following:
(1)A licensed pharmacy, as defined in subdivision (a) of Section 4037 of the Business and Professions Code, that is county owned or that contracts with the county pursuant to this division and is not on probation with the California State Board of Pharmacy.
(2)A licensed pharmacy, as defined in subdivision (a) of Section 4037 of the Business and Professions Code, that is owned and operated by a primary care clinic, as defined in Section 1204, that is licensed by the State Department of Public Health and is not on probation with the California State Board of Pharmacy.
(3)A primary care clinic, as defined in Section 1204, that is licensed by the State Department of Public Health and licensed to administer and dispense drugs pursuant to subparagraph (A) of paragraph (1) of subdivision (a) of Section 4180 of the Business and Professions Code and is not on probation with the California State Board of Pharmacy.
(c)Medication or medications means a dangerous drug, as defined in Section 4022 of the Business and Professions Code.
(d)Participating entity means an eligible entity that has received written or electronic documentation from the county health department pursuant to paragraph (3) of subdivision (a) of Section 150204 and that operates a repository and distribution program pursuant to this division.
(e)Tamper-evident packaging means an immediate, outer, or secondary container that is sealed by an organization eligible to donate medication pursuant to this division and that has a seal that must be broken in order to gain access to the containers medication.
SECTION 1.SEC. 2.Section 150204 of the Health and Safety Code is amended to read:150204.(a)(1)A county may establish, by an action of the county board of supervisors or by an action of the public health officer of the county, as directed by the county board of supervisors, a repository and distribution program for purposes of this division. The county shall advise the California State Board of Pharmacy within 30 days from the date it establishes a repository and distribution program.
(2)Only an eligible entity, pursuant to subdivision (a) of Section 150201, may participate in this program to dispense medication donated to the drug repository and distribution program.
(3)An eligible entity that seeks to participate in the program shall inform the county health department and the California State Board of Pharmacy in writing of its intent to participate in the program. An eligible entity may not participate in the program until it has received written or electronic documentation from the county health department confirming that the department has received its notice of intent.
(4)(A)A participating entity shall disclose to the county health department on a quarterly basis the name and location of the source of all donated medication it receives.
(B)A participating primary care clinic, as described in paragraph (3) of subdivision (a) of Section 150201 150201, shall disclose to the county health department the name of the licensed physician who shall be accountable to the California State Board of Pharmacy for the clinics program operations pursuant to this division. This physician shall be the professional director, as defined in subdivision (c) of Section 4182 of the Business and Professions Code.
(C)The county board of supervisors or public health officer of the county shall, upon request, make available to the California State Board of Pharmacy the information in this division.
(5)The county board of supervisors, the public health officer of the county, and the California State Board of Pharmacy may prohibit an eligible or participating entity from participating in the program if the entity does not comply with the provisions of the program, pursuant to this division. If the county board of supervisors, the public health officer of the county, or the California State Board of Pharmacy prohibits an eligible or participating entity from participating in the program, it shall provide written notice to the prohibited entity within 15 days of making this determination. The county board of supervisors, the public health officer of the county, and the California State Board of Pharmacy shall ensure that this notice also is provided to one another.
(b)A county that elects to establish a repository and distribution program pursuant to this division shall establish written procedures for, at a minimum, all of the following:
(1)Establishing eligibility for medically indigent patients who may participate in the program.
(2)Ensuring that patients eligible for the program shall not be charged for any medications provided under the program.
(3)Developing a formulary of medications appropriate for the repository and distribution program.
(4)Ensuring proper safety and management of any medications collected by and maintained under the authority of a participating entity.
(5)Ensuring the privacy of individuals for whom the medication was originally prescribed.
(6)Ensuring manufacturer recalls are handled appropriately for medications with and without lot numbers.
(c)Any medication donated to the repository and distribution program shall comply with the requirements specified in this division. Medication donated to the repository and distribution program shall meet all of the following criteria:
(1)The medication shall not be a controlled substance.
(2)The medication shall not have been adulterated, misbranded, or stored under conditions contrary to standards set by the United States Pharmacopoeia (USP) or the product manufacturer.
(3) The medication shall not have been in the possession of a patient or any individual member of the public, and in the case of medications donated by a health or care facility, as described in Section 150202, shall have been under the control of a staff member of the health or care facility who is licensed in California as a health care professional or has completed, at a minimum, the training requirements specified in Section 1569.69.
(d)(1)Only medication that is donated in unopened, tamper-evident packaging or modified unit dose containers that meet USP standards is eligible for donation to the repository and distribution program, provided lot numbers and expiration dates are affixed. Medication donated in opened containers shall not be dispensed by the repository and distribution program, and once identified, shall be quarantined immediately and handled and disposed of in accordance with the Medical Waste Management Act (Part 14 (commencing with Section 117600) of Division 104).
(2)(A)A medication that is the subject of a United States Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to Section 355-1 of Title 21 of the United States Code shall not be donated if this inventory transfer is prohibited by that strategy, or if the inventory transfer requires prior authorization from the manufacturer of the medication.
(B)A medication that is the subject of a United States Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to Section 355-1 of Title 21 of the United States Code, the donation of which is not prohibited pursuant to subparagraph (A), shall be managed and dispensed according to the requirements of that strategy.
(e)A pharmacist or physician at a participating entity shall use his or her professional judgment in determining whether donated medication meets the standards of this division before accepting or dispensing any medication under the repository and distribution program.
(f)A pharmacist or physician shall adhere to standard pharmacy practices, as required by state and federal law, when dispensing all medications.
(g)Medication that is donated to the repository and distribution program shall be handled in the following ways:
(1)Dispensed to an eligible patient.
(2)Destroyed.
(3)Returned to a reverse distributor or licensed waste hauler.
(4)(A)Transferred to another participating entity within the county to be dispensed to eligible patients pursuant to this division. Notwithstanding this paragraph, a participating county-owned pharmacy may transfer eligible donated medication to a participating county-owned pharmacy within another adjacent county that has adopted a program pursuant to this division, if the pharmacies transferring the medication have a written agreement between the entities that outlines protocols and procedures for safe and appropriate drug transfer that are consistent with this division.
(B)Medication donated under this division shall not be transferred by any participating entity more than once, and after it has been transferred, shall be dispensed to an eligible patient, destroyed, or returned to a reverse distributor or licensed waste hauler.
(C)Medication transferred pursuant to this paragraph shall be transferred with documentation that identifies the drug name, strength, and quantity of the medication, and the donation facility from where the medication originated shall be identified on medication packaging or in accompanying documentation. The document shall include a statement that the medication may not be transferred to another participating entity and must be handled pursuant to subparagraph (B). A copy of this document shall be kept by the participating entity transferring the medication and the participating entity receiving the medication.
(h)Medication that is donated to the repository and distribution program that does not meet the requirements of this division shall not be distributed or transferred under this program and shall be either destroyed or returned to a reverse distributor. Donated medication that does not meet the requirements of this division shall not be sold, dispensed, or otherwise transferred to any other entity.
(i)Medication donated to the repository and distribution program shall be maintained in the donated packaging units or new, properly labeled containers until dispensed to an eligible patient under this program, who presents a valid prescription. When dispensed to an eligible patient under this program, the medication shall be in a new and properly labeled container, specific to the eligible patient and ensuring the privacy of the individuals for whom the medication was initially dispensed. Expired medication shall not be dispensed.
(j)Medication donated to the repository and distribution program shall be segregated from the participating entitys other drug stock by physical means, for purposes including, but not limited to, inventory, accounting, and inspection.
(k)A participating entity shall keep complete records of the acquisition and disposition of medication donated to, and transferred, dispensed, and destroyed under, the repository and distribution program. These records shall be kept separate from the participating entitys other acquisition and disposition records and shall conform to the Pharmacy Law (Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code), including being readily retrievable.
(l)Local and county protocols established pursuant to this division shall conform to the Pharmacy Law regarding packaging, transporting, storing, and dispensing all medications.
(m)County protocols established for packaging, transporting, storing, and dispensing medications that require refrigeration, including, but not limited to, any biological product as defined in Section 351 of the Public Health Service Act (42 U.S.C. Sec. 262), an intravenously injected drug, or an infused drug, shall include specific procedures to ensure that these medications are packaged, transported, stored, and dispensed at appropriate temperatures and in accordance with USP standards and the Pharmacy Law.
(n)Notwithstanding any other provision of law, a participating entity shall follow the same procedural drug pedigree requirements for donated drugs as it would follow for drugs purchased from a wholesaler or directly from a drug manufacturer.
(a)(1)A county may establish, by an action of the county board of supervisors or by an action of the public health officer of the county, as directed by the county board of supervisors, a repository and distribution program for purposes of this division. The county shall advise the California State Board of Pharmacy within 30 days from the date it establishes a repository and distribution program.
(2)Only an eligible entity, pursuant to subdivision (a) of Section 150201, may participate in this program to dispense medication donated to the drug repository and distribution program.
(3)An eligible entity that seeks to participate in the program shall inform the county health department and the California State Board of Pharmacy in writing of its intent to participate in the program. An eligible entity may not participate in the program until it has received written or electronic documentation from the county health department confirming that the department has received its notice of intent.
(4)(A)A participating entity shall disclose to the county health department on a quarterly basis the name and location of the source of all donated medication it receives.
(B)A participating primary care clinic, as described in paragraph (3) of subdivision (a) of Section 150201 shall disclose to the county health department the name of the licensed physician who shall be accountable to the California State Board of Pharmacy for the clinics program operations pursuant to this division. This physician shall be the professional director, as defined in subdivision (c) of Section 4182 of the Business and Professions Code.
(C)The county board of supervisors or public health officer of the county shall, upon request, make available to the California State Board of Pharmacy the information in this division.
(5)The county board of supervisors, the public health officer of the county, and the California State Board of Pharmacy may prohibit an eligible or participating entity from participating in the program if the entity does not comply with the provisions of the program, pursuant to this division. If the county board of supervisors, the public health officer of the county, or the California State Board of Pharmacy prohibits an eligible or participating entity from participating in the program, it shall provide written notice to the prohibited entity within 15 days of making this determination. The county board of supervisors, the public health officer of the county, and the California State Board of Pharmacy shall ensure that this notice also is provided to one another.
(b)A county that elects to establish a repository and distribution program pursuant to this division shall establish written procedures for, at a minimum, all of the following:
(1)Establishing eligibility for medically indigent patients who may participate in the program.
(2)Ensuring that patients eligible for the program shall not be charged for any medications provided under the program.
(3)Developing a formulary of medications appropriate for the repository and distribution program.
(4)Ensuring proper safety and management of any medications collected by and maintained under the authority of a participating entity.
(5)Ensuring the privacy of individuals for whom the medication was originally prescribed.
(c)Any medication donated to the repository and distribution program shall comply with the requirements specified in this division. Medication donated to the repository and distribution program shall meet all of the following criteria:
(1)The medication shall not be a controlled substance.
(2)The medication shall not have been adulterated, misbranded, or stored under conditions contrary to standards set by the United States Pharmacopoeia (USP) or the product manufacturer.
(3) The medication shall not have been in the possession of a patient or any individual member of the public, and in the case of medications donated by a health or care facility, as described in Section 150202, shall have been under the control of a staff member of the health or care facility who is licensed in California as a health care professional or has completed, at a minimum, the training requirements specified in Section 1569.69.
(d)(1)Only medication that is donated in unopened, tamper-evident packaging or modified unit dose containers that meet USP standards is eligible for donation to the repository and distribution program, provided lot numbers and expiration dates are affixed. Medication donated in opened containers shall not be dispensed by the repository and distribution program, and once identified, shall be quarantined immediately and handled and disposed of in accordance with the Medical Waste Management Act (Part 14 (commencing with Section 117600) of Division 104).
(2)(A)A medication that is the subject of a United States Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to Section 355-1 of Title 21 of the United States Code shall not be donated if this inventory transfer is prohibited by that strategy, or if the inventory transfer requires prior authorization from the manufacturer of the medication.
(B)A medication that is the subject of a United States Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to Section 355-1 of Title 21 of the United States Code, the donation of which is not prohibited pursuant to subparagraph (A), shall be managed and dispensed according to the requirements of that strategy.
(e)A pharmacist or physician at a participating entity shall use his or her professional judgment in determining whether donated medication meets the standards of this division before accepting or dispensing any medication under the repository and distribution program.
(f)A pharmacist or physician shall adhere to standard pharmacy practices, as required by state and federal law, when dispensing all medications.
(g)Medication that is donated to the repository and distribution program shall be handled in the following ways:
(1)Dispensed to an eligible patient.
(2)Destroyed.
(3)Returned to a reverse distributor or licensed waste hauler.
(4)(A)Transferred to another participating entity within the county to be dispensed to eligible patients pursuant to this division. Notwithstanding this paragraph, a participating county-owned pharmacy may transfer eligible donated medication to a participating county-owned pharmacy within another adjacent county that has adopted a program pursuant to this division, if the pharmacies transferring the medication have a written agreement between the entities that outlines protocols and procedures for safe and appropriate drug transfer that are consistent with this division.
(B)Medication donated under this division shall not be transferred by any participating entity more than once, and after it has been transferred, shall be dispensed to an eligible patient, destroyed, or returned to a reverse distributor or licensed waste hauler.
(C)Medication transferred pursuant to this paragraph shall be transferred with documentation that identifies the drug name, strength, and quantity of the medication, and the donation facility from where the medication originated shall be identified on medication packaging or in accompanying documentation. The document shall include a statement that the medication may not be transferred to another participating entity and must be handled pursuant to subparagraph (B). A copy of this document shall be kept by the participating entity transferring the medication and the participating entity receiving the medication.
(h)Medication that is donated to the repository and distribution program that does not meet the requirements of this division shall not be distributed or transferred under this program and shall be either destroyed or returned to a reverse distributor. This medication Donated medication that does not meet the requirements of this division shall not be sold, dispensed, or otherwise transferred to any other entity.
(i)Medication donated to the repository and distribution program shall be maintained in the donated packaging units until dispensed to an eligible patient under this program, who presents a valid prescription. When dispensed to an eligible patient under this program, the medication shall be in a new and properly labeled container, specific to the eligible patient and ensuring the privacy of the individuals for whom the medication was initially dispensed. Expired medication shall not be dispensed.
(j)Medication donated to the repository and distribution program shall be segregated from the participating entitys other drug stock by physical means, for purposes including, but not limited to, inventory, accounting, and inspection.
(k)A participating entity shall keep complete records of the acquisition and disposition of medication donated to, and transferred, dispensed, and destroyed under, the repository and distribution program. These records shall be kept separate from the participating entitys other acquisition and disposition records and shall conform to the Pharmacy Law (Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code), including being readily retrievable.
(l)Local and county protocols established pursuant to this division shall conform to the Pharmacy Law regarding packaging, transporting, storing, and dispensing all medications.
(m)County protocols established for packaging, transporting, storing, and dispensing medications that require refrigeration, including, but not limited to, any biological product as defined in Section 351 of the Public Health Service Act (42 U.S.C. Sec. 262), an intravenously injected drug, or an infused drug, shall include specific procedures to ensure that these medications are packaged, transported, stored, and dispensed at appropriate temperatures and in accordance with USP standards and the Pharmacy Law.
(n)Notwithstanding any other provision of law, a participating entity shall follow the same procedural drug pedigree requirements for donated drugs as it would follow for drugs purchased from a wholesaler or directly from a drug manufacturer.
|
Date
|
Status
|
|---|---|
| Jul 7, 2015 | From committee: Do pass and re-refer to Com. on APPR. (Ayes 7. Noes 0.) (July 6). Re-referred to Com. on APPR. |
| Sep 13, 2016 | Chaptered by Secretary of State - Chapter 316, Statutes of 2016. |
| Sep 13, 2016 | Approved by the Governor. |
| Aug 30, 2016 | Enrolled and presented to the Governor at 4 p.m. |
| Aug 23, 2016 | Senate amendments concurred in. To Engrossing and Enrolling. (Ayes 80. Noes 0. Page 6153.). |
| Aug 23, 2016 | Senate amendments concurred in. To Engrossing and Enrolling. |
| Aug 19, 2016 | In Assembly. Concurrence in Senate amendments pending. May be considered on or after August 21 pursuant to Assembly Rule 77. |
| Aug 18, 2016 | Read third time. Passed. Ordered to the Assembly. (Ayes 38. Noes 0.). |
| Aug 18, 2016 | Read third time. Passed. Ordered to the Assembly. (Ayes 38. Noes 0. Page 5124.). |
| Aug 18, 2016 | Read third time. Passed. Ordered to the Assembly. |
| Aug 16, 2016 | Read second time. Ordered to third reading. |
| Aug 15, 2016 | Read third time and amended. Ordered to second reading. |
| Aug 9, 2016 | Read second time. Ordered to third reading. |
| Aug 8, 2016 | From committee: Be placed on second reading file pursuant to Senate Rule 28.8. |
| Aug 1, 2016 | From committee chair, with author's amendments: Amend, and re-refer to committee. Read second time, amended, and re-referred to Com. on APPR. |
| Aug 17, 2015 | In committee: Set, first hearing. Hearing canceled at the request of author. |
| Feb 26, 2015 | Read first time. To print. |
| Jul 1, 2015 | From committee chair, with author's amendments: Amend, and re-refer to committee. Read second time, amended, and re-referred to Com. on B., P. & E.D. |
| Jun 15, 2015 | In committee: Set, first hearing. Hearing canceled at the request of author. |
| Jun 11, 2015 | Referred to Com. on B., P. & E.D. |
| Jun 1, 2015 | Read third time. Passed. Ordered to the Senate. (Ayes 80. Noes 0. Page 1685.) |
| Jun 1, 2015 | Read third time. Passed. Ordered to the Senate. |
| Jun 1, 2015 | In Senate. Read first time. To Com. on RLS. for assignment. |
| May 7, 2015 | Read second time. Ordered to third reading. |
| May 6, 2015 | Read second time and amended. Ordered returned to second reading. |
| May 5, 2015 | From committee: Amend, and do pass as amended. (Ayes 17. Noes 0.) (May 5). |
| Apr 21, 2015 | In committee: Hearing postponed by committee. |
| Apr 6, 2015 | Re-referred to Com. on HEALTH. |
| Mar 26, 2015 | Referred to Com. on HEALTH. |
| Mar 26, 2015 | From committee chair, with author's amendments: Amend, and re-refer to Com. on HEALTH. Read second time and amended. |
| Feb 27, 2015 | From printer. May be heard in committee March 29. |
|
Date
|
Description
|
Location
|
Votes
|
|
|---|---|---|---|---|
| Aug 23, 2016 | AB 1069 GORDON Concurrence in Senate Amendments | Assembly Floor |
Passed |
|
| Aug 18, 2016 | Assembly 3rd Reading AB1069 Gordon By Beall | Senate Floor |
Passed |
|
| Jul 6, 2015 | Do pass, but first be re-referred to the Committee on [Appropriations] | Senate Standing Committee on Business, Professions and Economic Development |
Passed |
|
| Jun 1, 2015 | AB 1069 GORDON Assembly Third Reading | Assembly Floor |
Passed |
|
| May 5, 2015 | Do pass as amended. | Assembly Standing Committee on Health |
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 | Aug 18, 2016 |
| California Assisted Living Association | ** Support | Jul 6, 2015 |
| California Association Of Health Facilities | ** Support | Jul 6, 2015 |
| California Chronic Care Coalition | ** Support | Jul 6, 2015 |
| California State Board of Pharmacy | * Against Unless Amend | Jul 6, 2015 |
| Santa Clara County Board of Supervisors | ** Support | Jun 1, 2015 |
| Sirum | * Support | Jul 6, 2015 |
| Supporting Initiatives to Redistribute Unused Medicine | ** Support | Aug 18, 2016 |
CONCURRENCE IN SENATE AMENDMENTS
CSA1 Bill Id:AB 1069
Author:(Gordon)
As Amended Ver:August 15, 2016
Majority vote
ASSEMBLY: | 80-0 | (June 1, 2015) | SENATE: | 38-0 | (August 18, 2016) |
Original Committee Reference: HEALTH
SUMMARY: Authorizes a pharmacy that exists solely to operate the existing county-operated prescription drug collection and distribution program (Program) to repackage a reasonable quantity of donated medicine in anticipation of dispensing the medicine to its patient population. Requires the pharmacy to have repackaging policies and procedures in place for identifying and recalling medications; and requires the medication that is repackaged to be labeled with the earliest expiration date.
The Senate amendments narrow the scope of the bill to allow a pharmacy that participates in the Program to repackage donated medicine, as specified.
EXISTING LAW: Establishes the Program to distribute surplus medications to persons in need of financial assistance to ensure access to necessary pharmaceutical therapies. Establishes the California Board of Pharmacy (BOP) to regulate the practice of pharmacy and enforce the pharmacy law. Authorizes the BOP to adopt rules and regulations pertaining to establishments wherein any drug or device is compounded, prepared, furnished, or dispensed.
FISCAL EFFECT: According to the Senate Appropriations Committee, pursuant to Senate Rule 28.8, negligible state costs.
COMMENTS: The author states that when the Program was initially enacted, it was one of the first in the country and had few examples to draw from. Now that the voluntary drug repository and distribution program has been operational in Santa Clara County for almost five years and has provided enough medications to fill over 30,000 prescriptions, it has become evident that improvements are needed to help streamline the program's operations and help more low-income Californians get the medicine that they need to stay healthy. Earlier this year, Santa Clara County opened Better Health Pharmacy, the state's first pharmacy solely dedicated to collecting and dispensing unused, donated medication through the county's drug repository and distribution program. Under current law, participating entities must repackage medications in a new container prior to dispensing to a patient, but cannot do this in advance. Repackaging donated medicine is very time-consuming because most medicine comes in unit-dose packaging, which means each pill needs to be individually popped out and placed in a new container. This currently must be done while the patient waits. This bill would allow a pharmacy that exists solely to operate the repository and distribution program, such as Santa Clara County's Better Health Pharmacy, to repackage the medications in advance. This is needed to alleviate the time pressure on the pharmacist, prevent the patient from a needlessly long wait, improve the program's operations and workload, and ensure that patients are safe and better served.
Analysis Prepared by: Rosielyn Pulmano / HEALTH / (916) 319-2097 FN: 0004260
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | AB |
THIRD READING
Bill No: AB 1069
:
SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 7-0, 7/6/15
AYES: Hill, Bates, Berryhill, Block, Galgiani, Jackson, Mendoza
NO VOTE RECORDED: Hernandez, Wieckowski
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
ASSEMBLY FLOOR: 80-0, 6/1/15 - See last page for vote
SOURCE: Supporting Initiatives to Redistribute Unused Medicine
DIGEST: This bill authorizes a pharmacy that operates solely within a voluntary, county-operated prescription drug collection and distribution program to repackage a reasonable quantity of donated medicine in anticipation of dispensing the medicine to its patient population and requires that pharmacy to have repackaging policies and procedures in place for identifying and recalling medications.
Senate Floor Amendments of 8/15/16 add language to require medication that is repackaged to be labeled with the earliest expiration date.
Existing law:
- Establishes a voluntary unused medication repository and distribution program (Program) for the purpose of distributing surplus medications to persons in need of financial assistance to ensure access to necessary pharmaceutical therapies. (Health and Safety Code (HSC) § 150200-150207)
- Authorizes a county to establish a Program, by an action of the county board of supervisors or by an action of the public health officer of the county, as directed by the county board of supervisors. Requires the county to notify the Board of Pharmacy (Board) within 30 days from the date it establishes a Program. (HSC § 150204)
- Establishes requirements for medication donated to the Program, including that a pharmacist or physician shall adhere to standard pharmacy practices, as required by state and federal law, when dispensing all medications and medication that is donated to the Program shall either be dispensed to an eligible patient, destroyed, returned to a reverse distributor or licensed waste hauler or transferred to another participating entity within the county to be dispensed to eligible patients. Requires medication donated to the Program to be maintained in the donated packaging units until dispensed to an eligible patient who presents a valid prescription.
- Defines “repackager” as a person or entity that is registered with the federal FDA as a repackager and operates an establishment that packages finished drugs from bulk or that repackages dangerous drugs into different containers, excluding shipping containers. (Business and Professions Code (BPC) § 4044)
- Establishes a licensure category under the authority of the Board for a “surplus medication collection and distribution intermediary” (Intermediary) operating for the purpose of facilitating the donation of medications to, or transfer of medications between, participating entities under a county's Program. (BPC § 4169.5)
This bill authorizes a pharmacy that operates solely within a Program to repackage a reasonable quantity of donated medicine in anticipation of dispensing the medicine to its patient population, labeled with the earliest expiration date, and requires that pharmacy to have repackaging policies and procedures in place for identifying and recalling medications.
Background
California’s efforts to donate unused medication. SB 798 (Simitian, Chapter 444, Statutes of 2005) took effect in 2006, authorizing California counties to establish a “surplus prescription drug collection and distribution program” (Program) for the distribution of unused, unexpired medication to medically indigent patients. Under the Program, counties could adopt an ordinance to establish such a Program, under which skilled nursing facilities (SNFs), and SNFs that are institutions for mental disease, drug wholesalers, and drug manufacturers could donate unused medications to county-owned pharmacies, or pharmacies that contract with the county for dispensing to medically indigent patients free of charge. Prior to the enactment of SB 798, SNFs were required to either destroy the drugs in the presence of a pharmacist or nurse, or return the drugs to the issuing pharmacy (if unopened and in a sealed container) for disposition. SB 1329 (Simitian, Chapter 709, Statutes of 2012) made a number of changes to the way a Program could be authorized and the entities eligible to donate medications under a Program, authorizing a county public health officer, as delegated by a county board of supervisors, to implement a Program and adding several categories of licensed health care facilities that may donate medications. AB 467 (Stone, Chapter 10, Statutes of 2014) established a licensure category in the Pharmacy Law for a surplus medication collection and distribution Intermediary.
Two counties in California (Santa Clara and San Mateo) have established a Program through ordinance, although the Santa Clara Program is the only current operational program. As a result of changes in SB 1329, medication can be donated from a number of organizations, facilities and entities throughout the state, but the only recipients of donated medications must be located within Santa Clara County.
Need for program changes. This bill is sponsored by Supporting Initiatives to Redistribute Unused Medicine (SIRUM), an organization in the author’s district that coordinates Program efforts in Santa Clara County. Specifically, under the current law, participating entities must repackage medications in a new container prior to dispensing to a patient, but cannot do this in advance. The author states that repackaging donated medicine is very time-consuming because most medicine comes in unit-dose packaging, which means each pill needs to be individually popped out and placed in a new container. The author is concerned that this currently must be done while the patient waits and that allowing participating entities to repackage the medications in advance alleviates the time pressure on the pharmacist and prevents the patient from a needlessly long wait.
The author intends for the changes in this bill, which only impact a pharmacy operating solely under a Program, to increase efficiency by allowing for a reasonable quantity of donated medicine to be packaged in anticipation of dispensing the medicine to its patient population.
FISCAL EFFECT: Appropriation: Fiscal Com.: Local:
Supporting Initiatives to Redistribute Unused Medicine (source)
Board of Pharmacy
OPPOSITION: (Verified 8/16/16)
None received
ARGUMENTS IN SUPPORT: SIRUM believes that AB 1069 will increase access to necessary, and in many cases life‐sustaining, prescription drugs to medically indigent Californians while at the same time reduce the environmental impact of pharmaceutical waste.
ASSEMBLY FLOOR: 80-0, 6/1/15
AYES: Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Perea, Quirk, Rendon, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams, Wood, Atkins
8/16/16 17:38:50
**** END ****
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | AB |
THIRD READING
Bill No: AB 1069
:
SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 7-0, 7/6/15
AYES: Hill, Bates, Berryhill, Block, Galgiani, Jackson, Mendoza
NO VOTE RECORDED: Hernandez, Wieckowski
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
ASSEMBLY FLOOR: 80-0, 6/1/15 - See last page for vote
SOURCE: Supporting Initiatives to Redistribute Unused Medicine
DIGEST: This bill authorizes a pharmacy that operates solely within a voluntary, county-operated prescription drug collection and distribution program to repackage a reasonable quantity of donated medicine in anticipation of dispensing the medicine to its patient population and requires that pharmacy to have repackaging policies and procedures in place for identifying and recalling medications.
Existing law:
- Establishes a voluntary unused medication repository and distribution program (Program) for the purpose of distributing surplus medications to persons in need of financial assistance to ensure access to necessary pharmaceutical therapies. (Health and Safety Code (HSC) § 150200-150207)
- Authorizes a county to establish a Program, by an action of the county board of supervisors or by an action of the public health officer of the county, as directed by the county board of supervisors. Requires the county to notify the Board of Pharmacy (Board) within 30 days from the date it establishes a Program. (HSC § 150204)
- Establishes requirements for medication donated to the Program, including that a pharmacist or physician shall adhere to standard pharmacy practices, as required by state and federal law, when dispensing all medications and medication that is donated to the Program shall either be dispensed to an eligible patient, destroyed, returned to a reverse distributor or licensed waste hauler or transferred to another participating entity within the county to be dispensed to eligible patients. Requires medication donated to the Program to be maintained in the donated packaging units until dispensed to an eligible patient who presents a valid prescription.
- Defines “repackager” as a person or entity that is registered with the federal FDA as a repackager and operates an establishment that packages finished drugs from bulk or that repackages dangerous drugs into different containers, excluding shipping containers. (Business and Professions Code (BPC) § 4044)
- Establishes a licensure category under the authority of the Board for a “surplus medication collection and distribution intermediary” (Intermediary) operating for the purpose of facilitating the donation of medications to, or transfer of medications between, participating entities under a county's Program. (BPC § 4169.5)
This bill authorizes a pharmacy that operates solely within a Program to repackage a reasonable quantity of donated medicine in anticipation of dispensing the medicine to its patient population and requires that pharmacy to have repackaging policies and procedures in place for identifying and recalling medications.
Background
California’s efforts to donate unused medication. SB 798 (Simitian, Chapter 444, Statutes of 2005) took effect in 2006, authorizing California counties to establish a “surplus prescription drug collection and distribution program” (Program) for the distribution of unused, unexpired medication to medically indigent patients. Under the Program, counties could adopt an ordinance to establish such a Program, under which skilled nursing facilities (SNFs), and SNFs that are institutions for mental disease, drug wholesalers, and drug manufacturers could donate unused medications to county-owned pharmacies, or pharmacies that contract with the county for dispensing to medically indigent patients free of charge. Prior to the enactment of SB 798, SNFs were required to either destroy the drugs in the presence of a pharmacist or nurse, or return the drugs to the issuing pharmacy (if unopened and in a sealed container) for disposition. SB 1329 (Simitian, Chapter 709, Statutes of 2012) made a number of changes to the way a Program could be authorized and the entities eligible to donate medications under a Program, authorizing a county public health officer, as delegated by a county board of supervisors, to implement a Program and adding several categories of licensed health care facilities that may donate medications. AB 467 (Stone, Chapter 10, Statutes of 2014) established a licensure category in the Pharmacy Law for a surplus medication collection and distribution Intermediary.
Two counties in California (Santa Clara and San Mateo) have established a Program through ordinance, although the Santa Clara Program is the only current operational program. As a result of changes in SB 1329, medication can be donated from a number of organizations, facilities and entities throughout the state, but the only recipients of donated medications must be located within Santa Clara County.
Need for program changes. This bill is sponsored by Supporting Initiatives to Redistribute Unused Medicine (SIRUM), an organization in the author’s district that coordinates Program efforts in Santa Clara County. Specifically, under the current law, participating entities must repackage medications in a new container prior to dispensing to a patient, but cannot do this in advance. The author states that repackaging donated medicine is very time-consuming because most medicine comes in unit-dose packaging, which means each pill needs to be individually popped out and placed in a new container. The author is concerned that this currently must be done while the patient waits and that allowing participating entities to repackage the medications in advance alleviates the time pressure on the pharmacist and prevents the patient from a needlessly long wait.
The author intends for the changes in this bill, which only impact a pharmacy operating solely under a Program, to increase efficiency by allowing for a reasonable quantity of donated medicine to be packaged in anticipation of dispensing the medicine to its patient population.
FISCAL EFFECT: Appropriation: Fiscal Com.: Local:
Supporting Initiatives to Redistribute Unused Medicine (source)
OPPOSITION: (Verified 8/10/16)
None received
ARGUMENTS IN SUPPORT: SIRUM believes that AB 1069 will increase access to necessary, and in many cases life‐sustaining, prescription drugs to medically indigent Californians while at the same time reduce the environmental impact of pharmaceutical waste.
ASSEMBLY FLOOR: 80-0, 6/1/15
AYES: Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Perea, Quirk, Rendon, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams, Wood, Atkins
8/10/16 15:34:59
**** END ****
AB 1069 (Gordon) Page 12 of 12
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: AB 1069 Hearing Date: July 6, 2015
Author: |
Gordon |
||
Version: |
July 1, 2015 Amended |
||
Urgency: |
No |
Fiscal: |
No |
Consultant: |
Sarah Mason |
||
Subject: Prescription drugs: collection and distribution program.
SUMMARY:
Modifies the handling and repackaging requirements for donated pharmaceuticals at voluntary, county-operated prescription drug collection and distribution programs.
Existing law:
Provides for the practice of pharmacy and licensing and regulation of pharmacies and pharmacists in the Pharmacy Law by the Board of Pharmacy (Board) and within the Department of Consumer Affairs (DCA).
Exempts from the definition of manufacturer in Pharmacy Law a pharmacy that, at a patient’s request, repackages a drug previously dispensed to the patient or to the patient’s agent, pursuant to a prescription. (Business and Professions Code (BPC) § 4033 (a) (3))
Defines “repackager” as a person or entity that is registered with the federal FDA as a repackager and operates an establishment that packages finished drugs from bulk or that repackages dangerous drugs into different containers, excluding shipping containers. (BPC § 4044)
Establishes a licensure category under the authority of the Board for a “surplus medication collection and distribution intermediary” (Intermediary) operating for the purpose of facilitating the donation of medications to, or transfer of medications between, participating entities under a county's unused medication repository and distribution program (Program). (BPC § 4169.5)
Defines “donor organization” as any of the following health and care facilities that may donate centrally stored unused medications under the Program:
A licensed general acute care hospital.
A licensed acute psychiatric hospital.
A licensed skilled nursing facility, including a skilled nursing facility designated as an institution for mental disease.
A licensed intermediate care facility.
A licensed intermediate care facility/developmentally disabled-rehabilitative facility.
A licensed intermediate care facility/developmentally disabled-nursing facility.
A licensed correctional treatment center.
A licensed psychiatric health facility.
A licensed chemical dependency recovery hospital.
A licensed residential care facility for the elderly with 16 or more residents.
An approved mental health rehabilitation center. (Id.)
Prohibits an Intermediary from taking possession, custody, or control of dangerous drugs and devices. (Id.)
Requires an Intermediary to ensure that notification is provided to participating entities that a package has been shipped, when the surplus medication collection and distribution intermediary has knowledge of the shipment and provided logistical support to facilitate a shipment directly from a donor organization. (Id.)
Establishes the Sherman Food, Drug, and Cosmetic Law (Sherman Law), administered by the State Department of Public Health, which regulates the packaging, labeling, and advertising of drugs and devices. (Health and Safety Code (HSC) §§ 109875 et seq.)
Defines “manufacture” with the Sherman Law as the preparation, compounding, propagation, processing, or fabrication of any food, drug, device, or cosmetic. The term “manufacture” includes repackaging or otherwise changing the container, wrapper, or labeling of any food, drug, device, or cosmetic in furtherance of the distribution of the food, drug, device, or cosmetic. The term “manufacture” does not include repackaging from a bulk container by a retailer at the time of sale to its ultimate consumer. (HSC § 109970)
Establishes a voluntary Program for the purpose of distributing surplus medications to persons in need of financial assistance to ensure access to necessary pharmaceutical therapies. (HSC § 150200-150207)
Authorizes a county to establish a Program, by an action of the county board of supervisors or by an action of the public health officer of the county, as directed by the county board of supervisors. Requires the county to notify the Board within 30 days from the date it establishes a Program. (HSC § 150204)
Provides for the following related to medication donated to the Program: (Id)
The medication shall not be a controlled substance.
The medication shall not have been adulterated, misbranded, or stored under conditions contrary to standards set by the United States Pharmacopoeia (USP) or the product manufacturer.
The medication shall not have been in the possession of a patient or any individual member of the public, and in the case of medications donated by a health or care facility, shall have been under the control of a staff member of the health or care facility who is licensed in California as a health care professional or has completed, at a minimum, certain training requirements.
Only medication that is donated in unopened, tamper-evident packaging or modified unit dose containers that meet USP standards is eligible for donation to the Program, provided lot numbers and expiration dates are affixed. Medication donated in opened containers shall not be dispensed by the Program and once identified, shall be quarantined immediately and handled and disposed of in accordance with the Medical Waste Management Act.
A pharmacist or physician at a participating entity shall use his or her professional judgment in determining whether donated medication meets certain standards before accepting or dispensing any medication under the Program.
A pharmacist or physician shall adhere to standard pharmacy practices, as required by state and federal law, when dispensing all medications.
Medication that is donated to the Program shall either be dispensed to an eligible patient, destroyed, returned to a reverse distributor or licensed waste hauler or transferred to another participating entity within the county to be dispensed to eligible patients. Medication that is donated shall not be transferred by any participating entity more than once, and after it has been transferred, shall be dispensed to an eligible patient, destroyed, or returned to a reverse distributor or licensed waste hauler. Medication transferred pursuant to this paragraph shall be transferred with documentation that identifies the drug name, strength, and quantity of the medication, and the donation facility from where the medication originated shall be identified on medication packaging or in accompanying documentation.
Medication that is donated to the Program that does not meet the above requirements shall not be distributed or transferred under this program and shall be either destroyed or returned to a reverse distributor.
Medication donated to the Program shall be maintained in the donated packaging units until dispensed to an eligible patient under this program, who presents a valid prescription. When dispensed to an eligible patient under the Program, the medication shall be in a new and properly labeled container, specific to the eligible patient and ensuring the privacy of the individuals for whom the medication was initially dispensed. Expired medication shall not be dispensed.
Medication donated to the Program shall be segregated from the participating entity’s other drug stock by physical means, for purposes including, but not limited to, inventory, accounting, and inspection.
A participating entity shall keep complete records of the acquisition and disposition of medication donated to, and transferred, dispensed, and destroyed under the Program. These records shall be kept separate from the participating entity’s other acquisition and disposition records and be readily retrievable.
Local and county protocols established conform to the Pharmacy Law regarding packaging, transporting, storing, and dispensing all medications.
County protocols established for packaging, transporting, storing, and dispensing medications that require refrigeration, including, but not limited to, any biological product as defined in Section 351 of the Public Health Service Act (42 U.S.C. Sec. 262), an intravenously injected drug, or an infused drug, shall include specific procedures to ensure that these medications are packaged, transported, stored, and dispensed at appropriate temperatures and in accordance with USP standards and the Pharmacy Law.
A participating entity shall follow the same procedural drug pedigree requirements for donated drugs as it would follow for drugs purchased from a wholesaler or directly from a drug manufacturer.
Establishes the United States Food and Drug Administration (FDA) to protect the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products, and medical devices through the Food, Drug, and Cosmetic Act (FDCA). (21 United States Code (USC) 301 et seq.)
Establishes the Drug Supply Chain Security Act (Act), as part of the Drug Quality and Security Act (DQSA), which outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. (21 USC 351 et seq.)
This
bill:
Authorizes a participating entity to transfer eligible medication that has been donated to a Program to a participating entity in another county that has adopted a Program.
Authorizes a pharmacy to transfer up to fifteen percent of its donated medications annually.
Authorizes donated medication to be repackaged up to two times but does not require that donated medication must be repackaged two times. Requires the following safeguards to be met when donated medication is repackaged:
Medication shall be repackaged into a container than holds an individual prescription for a supply of up to 90 days or less.
Repackaged medication shall be labeled with all applicable lot numbers.
Repackaged medication shall be labeled with the earliest expiration date.
Repackaged medication shall be identifiable as donated medication.
Repackaged medication shall be labeled with the number of times that medication has been repackaged.
Makes technical changes.
FISCAL EFFECT:
Unknown. This bill is not keyed “fiscal” by Legislative Counsel.
COMMENTS:
Purpose. This measure is sponsored by Supporting Initiatives to Redistribute Unused Medicine (SIRUM). According to the Author, “because of the voluntary drug repository and distribution program’s operational requirements, Santa Clara County is currently the only county with an active program. When the program was initially enacted, it was one of the first in the country and had few examples to draw from. Now that the voluntary drug repository and distribution program has been operational for almost 5 years and has provided enough medications to fill over 30,000 prescriptions, it has become evident that improvements are needed to help streamline the program’s operations, encourage additional counties to participate, and help more low-income Californians get the medicine that they need to stay healthy.”
According to the Author, this bill makes two operational changes that would improve the voluntary drug repository and distribution program, specifically allowing for transfers of eligible donated medication from one county to another, regardless of whether the counties are adjacent as well as allowing for medication to be “repackaged” in advance.
The Author notes that under existing law, transfers between participating counties are only allowed when the counties are adjacent. Currently, only Santa Clara County operates a drug repository and distribution program, however, the Author states that in the future as counties establish the program, they would be limited to transfers if the counties are not adjacent. According to the Author, this restriction is unnecessary and can be viewed as a disincentive for counties looking to establish the program. The Author states that this bill removes the barrier by enabling transfers between participating counties that have established the program regardless of whether or not the counties are adjacent.
According to the Author, under the current law, participating entities must repackage medications in a new container prior to dispensing to a patient, but cannot do this in advance. The Author states that repackaging donated medicine is very time-consuming because most medicine comes in unit-dose packaging, which means each pill needs to be individually popped out and placed in a new container. The Author is concerned that this currently must be done while the patient waits and that allowing participating entities to repackage the medications in advance alleviates the time pressure on the pharmacist and prevents the patient from a needlessly long wait. The Author states that this bill would also prohibit donated medication from being repackaged more than two times so that prescription drugs which require limited handling are not needlessly repackaged.
Background. The issue of rising prescription drug costs, coupled with concerns about methods for disposal of unused or expired medication has led to efforts throughout the nation to reuse or recycle medication from certain, controlled health care settings and in turn make that medication available to indigent patients.
For many years, a common practice at many health care facilities has been to dispose of unused pharmaceuticals by flushing them down the toilet or pouring them down the drain, which in turn impacts water quality and water supply. According to a report by the Environmental Protection Agency (EPA), Unused Pharmaceuticals in the Health Care Industry, this practice stems from certain regulations governing acceptable methods for destroying unused drugs, as well as factors like size, ease and access of disposal and cost. Certain federal regulations constrain how some medications are destroyed or disposed, including the Controlled Substances Act (which includes disposal down the drain as an acceptable destruction option), Resource Conservation and Recovery Act (which requires certain types of medication and other hazardous wastes to be transported in approved containers to permitted hazardous waste disposal facilities by a hazardous waste transporter, a costly effort for many health facilities) and the Health Insurance Portability and Accountability Act (which requires long-term care facilities to destroy all pharmaceutical labels that contain personal information). The report states that some facilities are flushing to sewers as a primary means of disposal because it is easy and accessible, and in the past, public health agencies and health-related organizations advised the public to destroy unused medications this way as well.
California’s Efforts to Donate Unused Medication. SB 798 (Simitian, Chapter 444, Statutes of 2005) took effect in 2006, authorizing California counties to establish a “surplus prescription drug collection and distribution program” (Program) for the distribution of unused, unexpired medication to medically indigent patients. Under the Program, counties could adopt an ordinance to establish such a Program, under which skilled nursing facilities (SNFs), and SNFs that are institutions for mental disease, drug wholesalers, and drug manufacturers could donate unused medications to county-owned pharmacies, or pharmacies that contract with the county for dispensing to medically indigent patients free of charge. Prior to the enactment of SB 798, SNFs were required to either destroy the drugs in the presence of a pharmacist or nurse, or return the drugs to the issuing pharmacy (if unopened and in a sealed container) for disposition.
SB 1329 (Simitian, Chapter 709, Statutes of 2012) made a
number of changes to the way a Program could be authorized and the
entities eligible to donate medications under a Program. The bill
authorized a county public health officer, as delegated by a county
board of supervisors, to implement a Program, in addition to Program
implementation via county ordinance as authorized in SB 798. SB 1329
also added several categories of licensed health care facilities that
may donate medications. The bill also allowed both primary care
clinic pharmacies and primary care clinics that have Board licensees,
to administer and dispense medication, provided these Board licensees
are in good standing with the Board.
SB 1329 established
procedures relating to county and Board approval of participating
entities, as well as authority for a county and the Board to prohibit
a certain entity from participating in a Program.
In 2013, AB 467 (Stone, Chapter 10, Statutes of 2014) established a licensure category in the Pharmacy Law for a surplus medication collection and distribution Intermediary like SIRUM. The license requires an Intermediary to apply to the Board, provide certain information, pay a fee and maintain three years of complete records for which it facilitated the donation of medications to, or transfer of medications between, participating entities under the Program. AB 467 also expressly exempted an Intermediary licensee from licensure as a wholesaler. To date, there is no licensed intermediary in the state.
Two counties in California (Santa Clara and San Mateo) have established a Program through ordinance, although the Santa Clara Program is the only current operational program. As a result of changes in SB 1329, medication can be donated from a number of organizations, facilities and entities throughout the state, but the only recipients of donated medications must be located within Santa Clara County. Program efforts in Santa Clara County are coordinated by SIRUM.
Similar Programs in Other States. According to the National Conference of State Legislatures (NCSL), at least 38 states and Guam have enacted similar laws and programs which are similar to the Program a county may establish under current California law. While not all authorized programs are operational, California is unique in that a Program is established at the county level, while many other state programs exist at the state level or as part of a statewide effort.
The majority of laws throughout the nation authorizing the creation of a Program have the following characteristics:
Authorize the return of prescription drugs in single use or sealed packaging from state programs, nursing homes and other medical facilities.
Provisions in place for the financial terms of the donations or regulating sales.
Restrictions are in place aimed at assuring purity, safety and freshness of the products.
According to NCSL, all Programs provide that:
Donated drugs must not be expired and must have a verified future expiration date.
Controlled substances defined by the DEA must be excluded.
A state-licensed pharmacist or pharmacy must be part of the verification and distribution process.
Each patient receiving a drug must have a valid prescription form.
Examples of similar programs to California’s:
Connecticut (HB 6002, 2000) allows long-term care facilities to donate prescription drug products to vendor pharmacies or the state Department of Social Services for drug repackaging and reimbursement. The drugs are then donated to eligible patients. The drugs must be sealed in individually packaged units, returned to the vendor pharmacy within the recommended shelf, inspected by a licensed pharmacist, and cannot be a controlled substance.
Ohio (HB 221, 2003) allows any person, drug manufacturer, or healthcare facility to donate prescription drugs to any pharmacy, hospital, or nonprofit clinic that has elected to participate in the program and meets certain eligibility requirements established in rules adopted by their Pharmacy Board. The drugs can then be donated to individuals with a prescription. The drugs must be in their original sealed tamper-evident unit dose packaging.
Arkansas (HB 1031, 2005) allows a nearby nursing facility to donate drugs to charitable clinic pharmacies. The drugs are then donated to qualified indigent patients who are not eligible for Medicaid and cannot afford private health insurance. The charitable pharmacy can only accept drugs in their original sealed and tamper-evidence packaging, and it cannot accept controlled substances.
Iowa (HF 724, 2005) allows any person to donate prescription drugs and supplies to participating medical facilities or pharmacies. The drugs are donated to individuals or other eligible facilities or pharmacies for use. The drugs must be inspected and in their original sealed and tamper evidence packaging. The program is operated by the Iowa Prescription Drug Corporation, a non-profit organization that contracts with the State Department of Public Health.
Oklahoma (SB 1640, 2006) which inspired SB 798, allows pharmaceutical manufacturers and certain medical and skilled care facilities to donate unused prescription drugs to state, county, and city pharmacies and charitable clinics for the purpose of distributing the medications. The drugs are then donated to Oklahoma residents who are medically indigent. Controlled substances are not accepted.
Guam established medicine banks in 2004 which distribute donated drugs to indigent individuals.
Colorado, Florida, Kentucky, Minnesota, and Nebraska have also enacted programs but only for cancer drugs.
Michigan, New Mexico, Alabama and Indiana programs allow donations between correctional facilities.
New Hampshire only allows manufacturer’s samples to be donated.
New York allows donations back to the specific pharmacy that initially distributed it.
North Carolina, Oregon, South Carolina, and West Virginia have state medication repurposing policies but do not allow repositories.
Drug Supply Regulation. The Food, Drug and Cosmetic Act (FDCA) was passed by Congress to ensure public confidence in our drug distribution system and to require that drugs are both safe and effective. The FDCA requires FDA to regulate drug manufacturers and to approve drugs for sale but also requires state governments to regulate the drug distribution system by licensing and regulating drug wholesalers. In the simplest situation, a manufacturer sells drugs directly to one of the major wholesalers who then sell the drugs to a hospital or pharmacy. However, this simple distribution pattern is not the only distribution route taken through the supply chain. Typically, there is more than one wholesaler who receives the drugs before they reach the pharmacy. These transactions include transfers between separate facilities owned by major wholesalers and transfers between the major wholesalers and the large drug store chains that have their own wholesale facilities in the company distribution system. Common carriers may transport the drugs between licensed entities and in some cases will store, select and then ship products to pharmacies at the direction of manufacturers.
The distribution system is further complicated by the practice of “repackaging.” Unlike European countries and Canada, most drugs in the United States are not packaged in a “unit of use” size by the drug manufacturers. Instead, many drugs are sold by the manufacturers in large bulk containers and then are repackaged by additional companies into smaller containers for resale to the pharmacy. And the distribution system is complicated yet again by the existence of a “secondary” wholesale market. “Secondary” wholesalers are smaller companies (often regional down to small family owned companies) that focus their business on selling drugs to other wholesalers and serving smaller niche clients that are not routinely served by the major wholesalers (individual practitioners, small clinics, rural locations, etc.).
Drugs routinely move between both primary and secondary wholesalers and from pharmacies to secondary wholesalers as well. These intermediate steps pose the greatest opportunities for compromising the integrity of the drug distribution system. The primary threat to system integrity is the introduction of counterfeit products. Counterfeit drugs are most likely to be introduced into a distribution system that involves multiple wholesalers because drugs are largely untraceable unless they are only handled by a major wholesaler who purchases directly from the manufacturer. Without being able to trace a drug back, there is no assurance to the consumer that the drug has been stored and handled appropriately to preserve its potency and safety.
In response to a growing threat to the pharmaceutical supply chain
from counterfeit, misbranded, adulterated or diverted drugs,
California enacted SB 1307 (Figueroa, Chapter 857, Statutes of
2004) which made comprehensive changes to the drug distribution
system to protect the integrity of the pharmaceutical supply chain.
That legislation enacted the nation's strongest pharmaceutical
consumer protection measure and included provisions pertaining to the
licensure and qualifications of wholesalers, restrictions on
furnishing and the requirement, beginning January 1, 2007, of an
electronic pedigree (e-pedigree) to accompany and validate drug
distributions for the purpose of tracking each prescription drug at
the saleable unit (item) level through the distribution system.
Subsequent Board sponsored legislation, SB 1476 (Figueroa,
Chapter 658, Statutes of 2006) delayed the implementation date for
the e-pedigree component to January 1, 2009 and granted the Board the
authority to extend the deadline an additional two years to allow the
industry additional time to implement technologies necessary for
electronic pedigrees. In 2008, the Board sponsored SB 1307
(Ridley-Thomas, Chapter 713, Statutes of 2008), which amended the law
to resolve implementation issues, specifically staggering and
extending the implementation dates for
e-pedigree compliance,
establishing grandfathering of existing stock in the supply chain,
allowing the Board to establish criteria for inference, and
preempting California’s requirements in the event federal
legislation is enacted in this area. Per SB 1307, California’s
e-pedigree requirements for prescription drugs would have taken
effect on a staggered basis from January 1, 2015 through July 1,
2017:
50 percent of a manufacturer’s products by 2015 would
have had to have an
e-pedigree; the remaining 50 percent of the
manufacturer’s products would have had to have an e-pedigree by
2016; wholesalers and repackagers would have had to accept and
forward products with the e-pedigree by July 1, 2016 and; pharmacy
and pharmacy warehouses would have had to accept and pass e-pedigrees
by
July 1, 2017.
In 2013, Congress passed and President Obama signed H.R. 3034, the DQSA. Among other provisions, the bill created a national set of standards to track pharmaceuticals through the distribution chain, aimed at curbing illegal importation and patient harm caused by counterfeit drugs and devices. The new law contained two parts – the Compounding Quality Act and the Drug Supply Chain Security Act. The Compounding Quality Act created a voluntary compliance regime where compounding pharmacies that voluntarily register as “outsourcing facilities” will be subject to oversight by the FDA in much of the same way that traditional pharmaceutical manufacturers are monitored. The Drug Supply Chain Security Act built upon California's e-pedigree efforts to create a national electronic track and trace system for prescription drugs. The Act replaced the patchwork system adopted by individual states and created a unified national program. In doing this, the Act explicitly preempted any state's requirements for tracing products through the distribution system that are inconsistent with, more stringent than, or in addition to any of the requirements under the Act, effectively preempting California’s e-pedigree law.
Prior Related Legislation. AB 467 (Stone, Chapter 10, Statutes of 2014) established a licensure category for a surplus medication collection and distribution intermediary established for the purpose of facilitating the donation of medications to, or transfer of medications between, participating entities under a county’s unused medication repository and distribution program.
SB 1329 (Simitian, Chapter 709, Statutes of 2012) revised and recasted provisions authorizing a county to establish a drug repository and distribution program, to authorize a program to be established by an action of the county board of supervisors, or by the county public health officer, as specified and expanded the types of entities that are eligible to participate in a program.
SB 798 (Simitian, Chapter 444, Statutes of 2005) authorized the establishment of a voluntary prescription drug collection and distribution program for the purpose of distributing surplus prescription drugs to medically indigent patients free of charge.
Arguments in Support. Writing in support of the bill, SIRUM and the California Assisted Living Association (CALA) state that this bill will increase access to necessary, and in many cases life-sustaining, prescription drugs to medically indigent Californians while at the same time reducing the environment impact of pharmaceutical waste. According to the groups, AB 1069 will bring the program more in line with other states, enable additional counties to participate, and help more Californians get the medicine that they need to stay healthy.
The California Association of Health Facilities (CAHF) states, “With shrinking budgets for the healthcare safety net and rising healthcare costs for all Californians, enacting AB 1069 allows California to maximize quality patient care by reducing the financial burden of medicine acquisition and promoting environmentally sustainable healthcare practices.”
The California Chronic Care Coalition (CCCC) states that supports the concepts of this bill in part due to the documented success of Santa Clara County, currently the only county to have developed a voluntary drug repository and distribution program in our state. CCCC hopes that as a consequence of the changes in this bill, other counties throughout the state will be encouraged to seriously consider adopting this worthy program of merit.
Arguments in Opposition. The Board of Pharmacy has an oppose unless amended position on this bill. According to the Board, the proposed amendments would remove a pharmacist from the several aspects of the redistribution program, allow a participating entity to transfer drugs like a distributor without appropriate licensure and control and allow for the unlawful repackaging of and co-mingling of previously dispensed medications, including donated medications from various sources. According to the Board, this is all to the detriment of the patient. The Board states that the bill will eliminate existing patient protections established in state and federal law that are afforded to all Californians. The Board states that the elimination of important patient safety safeguards for a specific population of Californians - - indigent patients-- is both inappropriate and contrary to the Board's consumer protection mandate.
Policy Issues:
Is the Intention for Participating Entities to Repackage Medication? The goal of provisions in this bill related to repackaging are to decrease wait times for patients while easing pharmacist workload when dispensing donated medications. However, use of the term “repackage” may not be appropriate given the federal requirements outlined above for repackaging and given the constraints outlined in federal and state law for repackaging, which in a pharmacy setting, is only allowable for patient specific prescriptions. While certain facilities are authorized under federal law to perform anticipatory compounding before a patient actually needs the drug, the allowance is only for a limited amount, based on a patient’s prescribing history. U.S. Pharmacopeia guidance for those engaging in repackaging specifies that the functions are beyond the practice of a regular pharmacist. While it does not appear to be the Author’s intention to expand the authority of pharmacists participating in a Program beyond that of colleagues dispensing medication outside of a Program, the current language in this bill conflicts with current federal requirements outlining who can repackage.
Is the Intention for non-pharmacist personnel to perform the duties outlined in this bill for purposes of a Program? A participating entity under the Program includes facilities other than pharmacies, like primary care clinics, that may employ a pharmacist to perform inspections and provide some oversight of the facilities’ drug supply, but are not required to be present and on the premises at all times. It may not be the Author’s intention to allow individuals other than pharmacists to perform the activities outlined in the bill.
SUPPORT AND OPPOSITION:
Support:
Supporting Initiatives to Redistribute Unused Medicine (Sponsor)
California Assisted Living Association
California Association of Health Facilities
California Chronic Care Coalition
Opposition:
Board of Pharmacy
-- END --
AB 1069
Page 2
ASSEMBLY THIRD READING
AB 1069
(Gordon)
As Amended May 6, 2015
Majority vote
Committee |
Votes |
Ayes |
Noes |
Health |
17-0 |
Bonta, Maienschein, Bonilla, Burke, Chávez, Chiu, Gomez, Gonzalez, Lackey, Patterson, Ridley-Thomas, Rodriguez, Santiago, Steinorth, Thurmond, Waldron, Wood |
|
SUMMARY: Modifies the handling and repackaging requirements for donated pharmaceuticals at voluntary, county-operated prescription drug collection and distribution programs.
EXISTING LAW:
Establishes a voluntary, county-operated prescription drug collection and distribution program (Program) to distribute surplus medications to persons in need of financial assistance to ensure access to necessary pharmaceutical therapies.
Establishes the California Board of Pharmacy (BOP) to regulate the practice of pharmacy and enforce the pharmacy law. Authorizes the BOP to adopt rules and regulations pertaining to establishments wherein any drug or device is compounded, prepared, furnished, or dispensed.
FISCAL EFFECT: None
COMMENTS: The author states that this bill is necessary to improve current and future Programs by making two necessary operational changes which will allow for the packaging of medications in advance and allow for transfers to non-adjacent counties. When the Program was initially enacted, it was one of the first in the country and had few examples to draw from. The Program has been operational for almost five years and has provided enough medications to fill over 30,000 prescriptions. According to the author, it has become evident that improvements are needed to help streamline the program’s operations, encourage additional counties to participate, and help more low-income Californians get the medicine that they need to stay healthy.
Background. The Program was created by SB 798 (Simitian), Chapter 444, Statutes of 2005, and SB 1329 (Simitian), Chapter 709, Statutes of 2012, which authorize counties to establish a system to facilitate the collection and distribution of surplus unused medications to medically indigent persons. To date, two counties in California (Santa Clara and San Mateo) have established a Program through local ordinance, although Santa Clara is the only county currently operating a Program.
Supporting Initiatives to Redistribute Unused Medicine (SIRUM), the sponsor of this bill, is a tax-exempt nonprofit organization that connects safety-net clinics with unexpired, unopened donated drugs from suppliers, pharmacies, and health facilities. SIRUM works with Santa Clara County through their Program. SIRUM has reported that over 150 participating health facilities currently donate eligible medication. An October 2013 California Healthline report stated that, to date, SIRUM had administered the redistribution of 444,380 units of medicine worth about $1.5 million wholesale.
Similar Programs in Other States. According to the National Conference of State Legislatures, as of January 2015, at least 38 states and Guam have enacted laws and programs which are similar to the Program a county may establish under current California law. While many other state programs exist at the state level or as part of a statewide effort, California is unique in that a Program is established at the county level.
Support. SIRUM, sponsor of this bill, states that this bill will increase access to necessary, and in many cases life-sustaining, prescription drugs to medically indigent Californians while at the same time reducing the environmental impact of pharmaceutical waste. SIRUM states that with shrinking budgets for the healthcare safety net and rising healthcare costs for all Californians, enacting this bill would allow California to maximize quality patient care by reducing the financial burden of pharmaceutical acquisitions and promote environmentally sustainable healthcare practices. The Santa Clara County Board of Supervisors states that improving this program would encourage more counties to consider implementation of a drug collection and distribution program.
Opposition. The BOP opposes this bill because it would create conflicts between state and federal law. Regulation of drug distribution is complex, with a myriad of state and federal laws designed to ensure the safety and efficacy of prescription drugs. BOP states that they understand the author's intent to address the needs of indigent patients to secure access to medications; however, this bill in its current form eliminates existing patient protections established in state and federal law and, if improperly done, could harm patients.
Analysis Prepared by: Dharia McGrew / HEALTH / (916) 319-2097 FN: 0000357
AB 1069
Page 4
Date of Hearing: May 5, 2015
ASSEMBLY COMMITTEE ON HEALTH
Rob Bonta, Chair
AB 1069
(Gordon) – As Amended March 26, 2015
SUBJECT: Prescription drugs: collection and distribution program.
SUMMARY: Modifies the handling and repackaging requirements for donated pharmaceuticals at voluntary, county-operated prescription drug collection and distribution programs.
EXISTING LAW:
Establishes a voluntary, county-operated prescription drug collection and distribution program (Program) to distribute surplus medications to persons in need of financial assistance to ensure access to necessary pharmaceutical therapies.
Requires a county to establish written procedures for its Program including, at a minimum, the following:
Establishing eligibility for medically indigent patients who may participate in the Program;
Ensuring that patients eligible for the program are not charged for any medications provided under the Program;
Developing a formulary of medications appropriate for the Program;
Ensuring proper safety and management of any medications collected by and maintained under the authority of a participating entity; and,
Ensuring the privacy of individuals for whom the medication was originally prescribed.
Establishes a licensure and regulatory framework for a "surplus medication collection and distribution intermediary" (SMCDI) to facilitate the donation of surplus medications in California.
Specifies that only medication that is donated in unopened, tamper-evident packaging or modified unit dose containers that meet specified standards is eligible for donation to the program, provided that lot numbers and expiration dates are affixed; and, prohibits medication donated in opened containers from being dispensed by the program.
Establishes the California Board of Pharmacy (BOP) to regulate the practice of pharmacy and enforce the pharmacy law. Authorizes the BOP to adopt rules and regulations pertaining to establishments wherein any drug or device is compounded, prepared, furnished, or dispensed.
Requires, under federal law, all prescription drugs for human use be labeled with specific information including, but not limited to, the recommended or usual dosage, the active ingredients, and an identifying lot or control number from which it is possible to determine the complete manufacturing history of the package of the drug.
FISCAL EFFECT: None.
COMMENTS:
PURPOSE OF THIS BILL. The author states that this bill is necessary to improve current and future Programs by making four necessary operational changes which would allow for the packaging of medications in advance, address the handling of recalls, allow for transfers to non-adjacent counties, and define tamper-evident packaging in state law. When the Program was initially enacted, it was one of the first in the country and had few examples to draw from. The Program has been operational for almost five years and has provided enough medications to fill over 30,000 prescriptions. According to the author, it has become evident that improvements are needed to help streamline the program’s operations, encourage additional counties to participate, and help more low-income Californians get the medicine that they need to stay healthy.
BACKGROUND. The Program was created by SB 798 (Simitian), Chapter 444, Statutes of 2005, and SB 1329 (Simitian), Chapter 709, Statutes of 2012, which authorizes counties to establish a system to facilitate the collection and distribution of surplus unused medications to medically indigent persons. To date, two counties in California (Santa Clara and San Mateo) have established a Program through local ordinance, although the Santa Clara Program is the only current operational program.
Supporting Initiatives to Redistribute Unused Medicine (SIRUM), the sponsor of this bill, is a tax-exempt nonprofit organization that connects safety-net clinics with unexpired, unopened donated drugs from suppliers, pharmacies, and health facilities. SIRUM works with Santa Clara County through their Program. SIRUM has reported that over 150 participating health facilities currently donate eligible medication. An October 2013 California Healthline report stated that, to date, SIRUM had administered the redistribution of 444,380 units of medicine worth about $1.5 million wholesale.Similar Programs in Other States. According to the National Conference of State Legislatures, as of January 2015, at least 38 states and Guam have enacted laws and programs which are similar to the Program a county may establish under current California law. While many other state programs exist at the state level or as part of a statewide effort, California is unique in that a Program is established at the county level. Virtually all laws across states include some restrictions designed to assure purity, safety and freshness of the products. Unless otherwise noted, all programs require:
Donated drugs must not be expired and must have a verified future expiration date;
Controlled substances defined by the DEA must be excluded;
A state-licensed pharmacist or pharmacy must be part of the verification and distribution process; and,
Each patient receiving a drug must have a valid prescription form.
SUPPORT. SIRUM, sponsor of this bill, states that this bill will increase access to necessary, and in many cases life-sustaining, prescription drugs to medically indigent Californians while at the same time reducing the environmental impact of pharmaceutical waste. SIRUM states that with shrinking budgets for the healthcare safety net and rising healthcare costs for all Californians, enacting this bill would allow California to maximize quality patient care by reducing the financial burden of pharmaceutical acquisitions and promote environmentally sustainable healthcare practices. The Santa Clara County Board of Supervisors states that improving this program would encourage more counties to consider implementation of a drug collection and distribution program.
OPPOSITION. The BOP opposes this bill because it would create conflicts between state and federal law. Regulation of drug distribution is complex, with a myriad of state and federal laws designed to ensure the safety and efficacy of prescription drugs. BOP states that they understand the author's intent to address the needs of indigent patients to secure access to medications; however, this bill in its current form eliminates existing patient protections established in state and federal law and, if improperly done, could harm patients.
PREVIOUS LEGISLATION.
AB 467 (Stone), Chapter 10, Statutes of 2014, establishes a license and regulatory framework for an SMCDI to facilitate the donation of surplus medications in California.
SB 1329 expands the types of entities that can donate and dispense medication in the Program that provides donated medication to medically indigent patients, and allows counties to establish a program through an action by the county board or through an action of the public health officer of the county.
SB 798 establishes a voluntary drug collection and distribution program to allow surplus medications to be shared with persons in need of financial assistance.
POLICY COMMENTS:
Repackaging is not appropriate for all drugs. While the language of this bill intends to make the process of repackaging faster for pharmacists and waiting patients, it fails to address concerns that some classes of drugs should not be repackaged. Due to their chemical structure, some drugs may degrade when exposed to light or oxygen, and potentially lose efficacy each time they are repackaged. Moving forward, the author may wish to work with BOP to clarify certain drug classes which should have limited handling and repackaging.
There is only one county currently participating. Current law limits transfers of donated drugs to adjacent counties. This bill would remove that limitation, allowing transfer to any other county-operated pharmacy in the state. Since there is currently only one county operating a drug collection and redistribution pharmacy, the Committee may wish to consider whether this change is premature.
SUGGESTED AMENDMENTS.
Tamper-evident packaging definition is problematic. The definition created in this bill would be in conflict with federal law. That provision of this bill should be stricken.
Lot numbers are required under federal law. Provisions of this bill that would allow participating entities to hold and redistribute medications without lot numbers may be in conflict with federal law. Lot numbers are necessary, in case of recalls, to be able to track the entire manufacturing history and chain of custody of a medicine. Provisions of the bill removing the requirements for lot numbers should be stricken.
The number of times medicine is repackaged should be limited. Current law requires pharmacies to repackage donated drugs before distributing to new patients. The sponsors state that repackaging while the patient waits is unduly time consuming. However, there are concerns that the repackaging provisions of this bill are too vague. The author should amend the bill to limit the number of times medication can be repackaged.
REGISTERED SUPPORT / OPPOSITION:
Support
Supporting Initiatives to Redistribute Unused Medicine (sponsor)
California Association of Health Facilities
California Chronic Care Coalition (in concept)
Santa Clara County Board of Supervisors
Opposition
California State Board of Pharmacy (unless amended)
Analysis Prepared by: Dharia McGrew / HEALTH / (916) 319-2097
Discussed in Hearing
1MIN
Assembly Floor
2MIN
Senate Floor
8MIN
Senate Standing Committee on Business, Professions and Economic Development
1MIN
Assembly Floor
Bill Author
