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Division 116. Surplus Medication Collection And Distribution of California Health And Safety Code >> Division 116.
It is the intent of the Legislature in enacting this
division to authorize the establishment of a voluntary drug
repository and distribution program for the purpose of distributing
surplus medications to persons in need of financial assistance to
ensure access to necessary pharmaceutical therapies. It is also the
intent of the Legislature that the health and safety of Californians
are protected and promoted through this program, while reducing
unnecessary waste at licensed health and care facilities, by allowing
those facilities to donate unused and unexpired medications that
were never in the hands of a patient or resident and for which no
credit or refund to the patient or resident could be received.
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.
(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.
(a) Notwithstanding any other law, a donor organization is
defined, for purposes of this division, to refer to one of the
following health and care facilities that may donate centrally stored
unused medications under a program established pursuant to this
division:
(1) A licensed general acute care hospital, as defined in Section 1250.
(2) A licensed acute psychiatric hospital, as defined in Section 1250.
(3) A licensed skilled nursing facility, as defined in Section 1250, including a skilled nursing facility designated as an institution for mental disease.
(4) A licensed intermediate care facility, as defined in Section 1250.
(5) A licensed intermediate care facility/developmentally disabled-habilitative facility, as defined in Section 1250.
(6) A licensed intermediate care facility/developmentally disabled-nursing facility, as defined in Section 1250.
(7) A licensed correctional treatment center, as defined in Section 1250.
(8) A licensed psychiatric health facility, as defined in Section 1250.2.
(9) A licensed chemical dependency recovery hospital, as defined in Section 1250.3.
(10) A licensed residential care facility for the elderly, as defined in Section 1569.2, with 16 or more residents.
(11) An approved mental health rehabilitation center, as described in Section 5675 of the Welfare and Institutions Code.
(b) Medication donated by health and care facilities pursuant to subdivision (a) shall meet the requirements of subdivisions (c) and (d) of Section 150204 and shall be unexpired medication that would have otherwise been destroyed by the facility or another appropriate entity.
(c) Medication eligible for donation by the health and care facilities pursuant to subdivision (a) shall be directly delivered from the dispensing pharmacy, wholesaler or manufacturer, to the health or care facility and subsequently centrally stored. Centrally stored medication that originated from a patient or resident is not eligible for donation under this division.
(1) A licensed general acute care hospital, as defined in Section 1250.
(2) A licensed acute psychiatric hospital, as defined in Section 1250.
(3) A licensed skilled nursing facility, as defined in Section 1250, including a skilled nursing facility designated as an institution for mental disease.
(4) A licensed intermediate care facility, as defined in Section 1250.
(5) A licensed intermediate care facility/developmentally disabled-habilitative facility, as defined in Section 1250.
(6) A licensed intermediate care facility/developmentally disabled-nursing facility, as defined in Section 1250.
(7) A licensed correctional treatment center, as defined in Section 1250.
(8) A licensed psychiatric health facility, as defined in Section 1250.2.
(9) A licensed chemical dependency recovery hospital, as defined in Section 1250.3.
(10) A licensed residential care facility for the elderly, as defined in Section 1569.2, with 16 or more residents.
(11) An approved mental health rehabilitation center, as described in Section 5675 of the Welfare and Institutions Code.
(b) Medication donated by health and care facilities pursuant to subdivision (a) shall meet the requirements of subdivisions (c) and (d) of Section 150204 and shall be unexpired medication that would have otherwise been destroyed by the facility or another appropriate entity.
(c) Medication eligible for donation by the health and care facilities pursuant to subdivision (a) shall be directly delivered from the dispensing pharmacy, wholesaler or manufacturer, to the health or care facility and subsequently centrally stored. Centrally stored medication that originated from a patient or resident is not eligible for donation under this division.
Notwithstanding any other law, a pharmacy, licensed in
California and not on probation with the California State Board of
Pharmacy, whose primary or sole type of pharmacy practice type is
limited to a skilled nursing facility, home health care, board and
care, or mail order, may donate unused, unexpired medication that
meets the requirements of subdivisions (c) and (d) of Section 150204,
under a program established pursuant to this division and that meets
either of the following requirements:
(a) The medication was received directly from a manufacturer or wholesaler.
(b) The medication was returned from a health facility to the issuing pharmacy, in a manner consistent with state and federal law.
(a) The medication was received directly from a manufacturer or wholesaler.
(b) The medication was returned from a health facility to the issuing pharmacy, in a manner consistent with state and federal law.
Notwithstanding any other provision of law, a wholesaler
licensed pursuant to Article 11 (commencing with Section 4160) of
Chapter 9 of Division 2 of the Business and Professions Code and a
drug manufacturer that is legally authorized under federal law to
manufacture and sell pharmaceutical drugs may donate unused
medications under the voluntary drug repository and distribution
program established by a county pursuant to this division.
(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 clinic's 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 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 entity's 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 entity's 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.
(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 clinic's 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 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 entity's 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 entity's 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) The following persons and entities shall not be subject
to criminal or civil liability for injury caused when donating,
accepting, or dispensing prescription drugs in compliance with this
division:
(1) A prescription drug manufacturer, wholesaler, governmental entity, or participating entity.
(2) A pharmacist or physician who accepts or dispenses prescription drugs.
(3) A licensed health or care facility, as described in Section 150202, or a pharmacy, as described in Section 150202.5.
(b) A surplus medication collection and distribution intermediary, as described in Section 150208, shall not be subject to criminal or civil liability for injury caused when facilitating the donation of medications to or transfer of medications in compliance with this division.
(1) A prescription drug manufacturer, wholesaler, governmental entity, or participating entity.
(2) A pharmacist or physician who accepts or dispenses prescription drugs.
(3) A licensed health or care facility, as described in Section 150202, or a pharmacy, as described in Section 150202.5.
(b) A surplus medication collection and distribution intermediary, as described in Section 150208, shall not be subject to criminal or civil liability for injury caused when facilitating the donation of medications to or transfer of medications in compliance with this division.
The immunities provided in Section 150205 shall not apply
in cases of noncompliance with this division, bad faith, or gross
negligence.
Nothing in this division shall affect disciplinary actions
taken by licensing and regulatory agencies.
(a) A surplus medication collection and distribution
intermediary that is licensed pursuant to Section 4169.5 of the
Business and Professions Code, established for the purpose of
facilitating the donation of medications to or transfer of
medications between participating entities under a program
established pursuant to this division is authorized to operate under
this section.
(b) A surplus medication collection and distribution intermediary shall comply with the following:
(1) It shall not take possession, custody, or control of dangerous drugs and devices.
(2) It shall 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, as defined in subdivision (a) of Section 150202, to a participating entity.
(3) It shall not select, or direct a donor organization, as defined in subdivision (a) of Section 150202, to select, a specific participating entity to receive surplus medications.
(c) A surplus medication collection and distribution intermediary is authorized to do the following:
(1) Charge membership, administrative, or overhead fees sufficient to cover the reasonable costs of the support and services provided.
(2) Contract directly with a county to facilitate the donation of medications to or transfer of medications between participating entities and provide general support in a county's implementation of a program established pursuant to this division.
(d) No participating entities shall receive donated medication directly from the surplus medication collection and distribution intermediary.
(b) A surplus medication collection and distribution intermediary shall comply with the following:
(1) It shall not take possession, custody, or control of dangerous drugs and devices.
(2) It shall 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, as defined in subdivision (a) of Section 150202, to a participating entity.
(3) It shall not select, or direct a donor organization, as defined in subdivision (a) of Section 150202, to select, a specific participating entity to receive surplus medications.
(c) A surplus medication collection and distribution intermediary is authorized to do the following:
(1) Charge membership, administrative, or overhead fees sufficient to cover the reasonable costs of the support and services provided.
(2) Contract directly with a county to facilitate the donation of medications to or transfer of medications between participating entities and provide general support in a county's implementation of a program established pursuant to this division.
(d) No participating entities shall receive donated medication directly from the surplus medication collection and distribution intermediary.
