Section § 150200

Explanation

This law aims to create a voluntary program where licensed health facilities can donate surplus medications they have, which haven't been given to patients, to people who need financial help to access these medications. The goal is to help Californians get the medications they need, protect their health, and reduce waste by redistributing drugs that would otherwise go unused but are still safe and effective.

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.

Section § 150201

Explanation

This section provides definitions for terms used in a specific legal division. It defines a "donor organization" by referencing another section. An "eligible entity" can be a county-owned or county-contracted pharmacy, or one owned by a primary care clinic, provided they aren't on probation. These entities must be licensed and meet specific criteria. "Medication" refers to any dangerous drug as classified under a specific code. A "participating entity" is one that has documentation from the county health department to run a medication repository and distribution program.

For purposes of this division:
(a)CA Health & Safety Code § 150201(a) “Donor organization” means an entity described in subdivision (a) of Section 150202.
(b)CA Health & Safety Code § 150201(b) “Eligible entity” means all of the following:
(1)CA Health & Safety Code § 150201(b)(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)CA Health & Safety Code § 150201(b)(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)CA Health & Safety Code § 150201(b)(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)CA Health & Safety Code § 150201(c) “Medication” or “medications” means a dangerous drug, as defined in Section 4022 of the Business and Professions Code.
(d)CA Health & Safety Code § 150201(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.

Section § 150202

Explanation

This law defines what qualifies as a 'donor organization' in the context of donating unused medications. It lists specific types of licensed facilities, such as hospitals, nursing homes, correctional and juvenile facilities, and more, that can donate these medications.

Donated medications must be unexpired and were previously designated for destruction. The medications must have been received directly from a pharmacy, wholesaler, or manufacturer and must be centrally stored by the facility. Medications that come from a patient or resident are not eligible for donation.

(a)CA Health & Safety Code § 150202(a) Notwithstanding any other law, a donor organization is defined, for purposes of this division, to refer to the following facilities, hospitals, and entities that legally possess centrally stored, unused medication:
(1)CA Health & Safety Code § 150202(a)(1) A licensed general acute care hospital, as defined in Section 1250.
(2)CA Health & Safety Code § 150202(a)(2) A licensed acute psychiatric hospital, as defined in Section 1250.
(3)CA Health & Safety Code § 150202(a)(3) A licensed skilled nursing facility, as defined in Section 1250, including a skilled nursing facility designated as an institution for mental disease.
(4)CA Health & Safety Code § 150202(a)(4) A licensed intermediate care facility, as defined in Section 1250.
(5)CA Health & Safety Code § 150202(a)(5) A licensed intermediate care facility/developmentally disabled-habilitative facility, as defined in Section 1250.
(6)CA Health & Safety Code § 150202(a)(6) A licensed intermediate care facility/developmentally disabled-nursing facility, as defined in Section 1250.
(7)CA Health & Safety Code § 150202(a)(7) A licensed correctional treatment center, as defined in Section 1250.
(8)CA Health & Safety Code § 150202(a)(8) A licensed psychiatric health facility, as defined in Section 1250.2.
(9)CA Health & Safety Code § 150202(a)(9) A licensed chemical dependency recovery hospital, as defined in Section 1250.3.
(10)CA Health & Safety Code § 150202(a)(10) A licensed residential care facility for the elderly, as defined in Section 1569.2, with 16 or more residents.
(11)CA Health & Safety Code § 150202(a)(11) An approved mental health rehabilitation center, as described in Section 5675 of the Welfare and Institutions Code.
(12)CA Health & Safety Code § 150202(a)(12) An eligible entity, as defined in subdivision (b) of Section 150201.
(13)CA Health & Safety Code § 150202(a)(13) A juvenile facility, as described in Section 208.3 of the Welfare and Institutions Code.
(14)CA Health & Safety Code § 150202(a)(14) A local detention facility, as described in Section 6031.4 of the Penal Code.
(15)CA Health & Safety Code § 150202(a)(15) A facility that is any of the following:
(A)CA Health & Safety Code § 150202(a)(15)(A) Licensed by the State Department of Social Services.
(B)CA Health & Safety Code § 150202(a)(15)(B) Licensed by the State Department of Public Health.
(C)CA Health & Safety Code § 150202(a)(15)(C) Licensed by the State Department of Health Care Services.
(D)CA Health & Safety Code § 150202(a)(15)(D) Licensed by or under the jurisdiction of the Department of Corrections and Rehabilitation.
(E)CA Health & Safety Code § 150202(a)(15)(E) Licensed by or under the jurisdiction of the Division of Juvenile Justice.
(16)CA Health & Safety Code § 150202(a)(16) A licensed home health agency, as defined in Section 1725.
(17)CA Health & Safety Code § 150202(a)(17) A licensed hospice agency, as defined in Section 1745.
(18)CA Health & Safety Code § 150202(a)(18) A licensed hospice facility, as defined in subdivision (n) of Section 1250.
(b)CA Health & Safety Code § 150202(b) Medication donated by 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)CA Health & Safety Code § 150202(c) Medication eligible for donation by facilities pursuant to subdivision (a) shall be directly delivered from the dispensing pharmacy, wholesaler or manufacturer, to the facility and subsequently centrally stored. Centrally stored medication that originated from a patient or resident is not eligible for donation under this division.

Section § 150202.5

Explanation

This California law allows pharmacies, that are licensed and not on probation, to donate unused and unexpired medications under certain conditions. The medication must either have been obtained directly from a manufacturer or wholesaler, or returned from a health facility to the pharmacy following legal guidelines.

Notwithstanding any other law, a pharmacy, licensed in California and not on probation with the California State Board of Pharmacy 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)CA Health & Safety Code § 150202.5(a) The medication was received directly from a manufacturer or wholesaler.
(b)CA Health & Safety Code § 150202.5(b) The medication was returned from a health facility to the issuing pharmacy, in a manner consistent with state and federal law.

Section § 150203

Explanation

This law states that if you are a wholesaler with the right license or a drug manufacturer approved by federal law, you can donate unused medications to a county-run program. This program is set up to collect and distribute these medications to people who need them.

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.

Section § 150204

Explanation

This law allows counties in California to set up programs for collecting and distributing donated medications, as directed by the county board of supervisors or public health officers. Eligible entities must notify the county health department and State Board of Pharmacy before participating and must disclose details about medication sources quarterly.

Medications can only be donated if they're unopened and meet specific safety standards, and controlled substances are not allowed. Pharmacies and physicians must ensure the medications are safe to use and adhere to standard practices. Donated meds must be properly stored, labeled, and can only be distributed to eligible patients, destroyed, or returned if necessary.

Counties are responsible for creating procedures to verify patient eligibility and ensure medications are distributed at no charge. Comprehensive records must be kept separate from regular pharmacy records, and protocols must comply with existing Pharmacy Laws, especially concerning medication handling and storage requirements, including temperature monitoring for refrigerated drugs.

(a)Copy CA Health & Safety Code § 150204(a)
(1)Copy CA Health & Safety Code § 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)CA Health & Safety Code § 150204(a)(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)CA Health & Safety Code § 150204(a)(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)Copy CA Health & Safety Code § 150204(a)(4)
(A)Copy CA Health & Safety Code § 150204(a)(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)CA Health & Safety Code § 150204(a)(4)(A)(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 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)CA Health & Safety Code § 150204(a)(4)(A)(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)CA Health & Safety Code § 150204(a)(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)CA Health & Safety Code § 150204(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)CA Health & Safety Code § 150204(b)(1) Establishing eligibility for medically indigent patients who may participate in the program.
(2)CA Health & Safety Code § 150204(b)(2) Ensuring that patients eligible for the program shall not be charged for any medications provided under the program.
(3)CA Health & Safety Code § 150204(b)(3) Developing a formulary of medications appropriate for the repository and distribution program.
(4)CA Health & Safety Code § 150204(b)(4) Ensuring proper safety and management of any medications collected by and maintained under the authority of a participating entity.
(5)CA Health & Safety Code § 150204(b)(5) Ensuring the privacy of individuals for whom the medication was originally prescribed.
(c)CA Health & Safety Code § 150204(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)CA Health & Safety Code § 150204(c)(1) The medication shall not be a controlled substance.
(2)CA Health & Safety Code § 150204(c)(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)CA Health & Safety Code § 150204(c)(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)Copy CA Health & Safety Code § 150204(d)
(1)Copy CA Health & Safety Code § 150204(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)Copy CA Health & Safety Code § 150204(d)(2)
(A)Copy CA Health & Safety Code § 150204(d)(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)CA Health & Safety Code § 150204(d)(2)(A)(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)CA Health & Safety Code § 150204(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)CA Health & Safety Code § 150204(f) A pharmacist or physician shall adhere to standard pharmacy practices, as required by state and federal law, when dispensing all medications.
(g)CA Health & Safety Code § 150204(g) Medication that is donated to the repository and distribution program shall be handled in the following ways:
(1)CA Health & Safety Code § 150204(g)(1) Dispensed to an eligible patient.
(2)CA Health & Safety Code § 150204(g)(2) Destroyed.
(3)CA Health & Safety Code § 150204(g)(3) Returned to a reverse distributor or licensed waste hauler.
(4)Copy CA Health & Safety Code § 150204(g)(4)
(A)Copy CA Health & Safety Code § 150204(g)(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)CA Health & Safety Code § 150204(g)(4)(A)(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)CA Health & Safety Code § 150204(g)(4)(A)(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)CA Health & Safety Code § 150204(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)Copy CA Health & Safety Code § 150204(i)
(1)Copy CA Health & Safety Code § 150204(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)CA Health & Safety Code § 150204(i)(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)CA Health & Safety Code § 150204(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)CA Health & Safety Code § 150204(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)CA Health & Safety Code § 150204(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)CA Health & Safety Code § 150204(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)CA Health & Safety Code § 150204(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.

Section § 150204.5

Explanation

This law sets up a trial program in Santa Clara, San Mateo, and San Francisco to see if creating a system for storing and distributing prescription drugs is feasible and beneficial. The program will run until January 1, 2030.

Participating pharmacies in this program must be owned by the named counties or city, be properly licensed, and in good standing with the pharmacy board. These pharmacies must follow all usual legal pharmacy rules during the program.

Importantly, this specific pilot program has exceptions from certain regulations that normally apply.

(a)CA Health & Safety Code § 150204.5(a) A regional pilot program may be established in the Counties of Santa Clara and San Mateo and the City and County of San Francisco to determine the feasibility and benefits of implementing and maintaining a repository and distribution program. The regional pilot program shall run until January 1, 2030.
(b)CA Health & Safety Code § 150204.5(b) Participating pharmacies in the regional pilot program shall be owned or operated by the Counties of Santa Clara or San Mateo or the City and County of San Francisco, licensed in California, and not on probation with the California State Board of Pharmacy.
(c)Copy CA Health & Safety Code § 150204.5(c)
(1)Copy CA Health & Safety Code § 150204.5(c)(1) Participants in the regional pilot program shall develop and implement their programs in accordance with this division.
(2)CA Health & Safety Code § 150204.5(c)(2) While participating in the regional pilot program, participants shall continue to meet all other legal responsibilities and requirements relating to pharmacy services and comply with all relevant state and federal statutes when administering their programs.
(d)CA Health & Safety Code § 150204.5(d) Section 150204 shall not apply to a pilot program established pursuant to this section and Section 150204.6.

Section § 150204.6

Explanation

This law allows certain counties in California to create programs for donating and distributing medications. Counties must inform the California State Board of Pharmacy when they start such programs. Eligible entities can join the program by notifying the county health department. Only unopened medications not including controlled substances can be donated, ensuring safety and proper handling. Any donated medications must meet strict safety guidelines and cannot come from the general public. A designee must oversee operations, and the program must have written procedures for handling and dispensing medications without charge to patients. Records of all transactions must be kept. The California State Board of Pharmacy will evaluate these programs and report to the legislature by 2028. The law is set to expire in 2030.

(a)Copy CA Health & Safety Code § 150204.6(a)
(1)Copy CA Health & Safety Code § 150204.6(a)(1) A county specified in Section 150204.5 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)CA Health & Safety Code § 150204.6(a)(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)CA Health & Safety Code § 150204.6(a)(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)Copy CA Health & Safety Code § 150204.6(a)(4)
(A)Copy CA Health & Safety Code § 150204.6(a)(4)(A) 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 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.
(B)CA Health & Safety Code § 150204.6(a)(4)(A)(B) 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)CA Health & Safety Code § 150204.6(a)(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 each ensure that this notice is also provided to the other two entities.
(b)CA Health & Safety Code § 150204.6(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)CA Health & Safety Code § 150204.6(b)(1) Establishing eligibility for medically indigent patients who may participate in the program.
(2)CA Health & Safety Code § 150204.6(b)(2) Ensuring that patients eligible for the program shall not be charged for any medications provided under the program.
(3)CA Health & Safety Code § 150204.6(b)(3) Developing a formulary of medications appropriate for the repository and distribution program.
(4)CA Health & Safety Code § 150204.6(b)(4) Ensuring proper safety and management of any medications collected by and maintained under the authority of a participating entity.
(5)CA Health & Safety Code § 150204.6(b)(5) Ensuring the privacy of individuals for whom the medication was originally prescribed.
(c)CA Health & Safety Code § 150204.6(c) Medication donated to the repository and distribution program or transferred between participating entities 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)CA Health & Safety Code § 150204.6(c)(1) The medication shall not be a controlled substance.
(2)CA Health & Safety Code § 150204.6(c)(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)CA Health & Safety Code § 150204.6(c)(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 hospital, facility, or entity, 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)Copy CA Health & Safety Code § 150204.6(d)
(1)Copy CA Health & Safety Code § 150204.6(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)Copy CA Health & Safety Code § 150204.6(d)(2)
(A)Copy CA Health & Safety Code § 150204.6(d)(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)CA Health & Safety Code § 150204.6(d)(2)(A)(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)CA Health & Safety Code § 150204.6(e) A pharmacist or physician at a participating entity shall use their professional judgment in determining whether donated medication meets the standards of this division before accepting or dispensing medication under the repository and distribution program.
(f)CA Health & Safety Code § 150204.6(f) A pharmacist or physician shall adhere to standard pharmacy practices, as required by state and federal law, when dispensing all medications.
(g)CA Health & Safety Code § 150204.6(g) Medication that is donated to the repository and distribution program shall be handled in the following ways:
(1)CA Health & Safety Code § 150204.6(g)(1) Dispensed to an eligible patient.
(2)CA Health & Safety Code § 150204.6(g)(2) Destroyed.
(3)CA Health & Safety Code § 150204.6(g)(3) Returned to a reverse distributor or licensed waste hauler.
(4)Copy CA Health & Safety Code § 150204.6(g)(4)
(A)Copy CA Health & Safety Code § 150204.6(g)(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)CA Health & Safety Code § 150204.6(g)(4)(A)(B) Medication donated under this division may be transferred more than once only within the county and after the final transfer shall be dispensed to an eligible patient, destroyed, or returned to a reverse distributor or licensed waste hauler.
(C)CA Health & Safety Code § 150204.6(g)(4)(A)(C) Medication transferred pursuant to this paragraph shall be transferred with documentation that identifies the drug name, strength, and quantity of the medication, original manufacturer lot numbers, and current expiration date. The document shall include a statement that the medication shall 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.
(D)CA Health & Safety Code § 150204.6(g)(4)(A)(D) Medication donated from multiple facilities under this division may be commingled by the participating entity. However, in the event of a recall, recalled medication shall be destroyed at the National Drug Code level.
(E)CA Health & Safety Code § 150204.6(g)(4)(A)(E) Participating facilities shall maintain a system for recording and logging donated medication which allows the tracking of medication in each repackaged container back to the facility or facilities that donated the medication.
(h)CA Health & Safety Code § 150204.6(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)Copy CA Health & Safety Code § 150204.6(i)
(1)Copy CA Health & Safety Code § 150204.6(i)(1) When dispensed to an eligible patient under this program, the donated medication shall be in a new, properly labeled container, specific to the eligible patient and ensuring the privacy of the individuals for whom the medication was initially dispensed. However, medications donated in sealed manufacturer’s packaging are not required to be placed into a new container, but shall otherwise be appropriately labeled. Expired medication shall not be dispensed.
(2)CA Health & Safety Code § 150204.6(i)(2) 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. Repackaged medication can only be dispensed to patients within the county.
(j)CA Health & Safety Code § 150204.6(j) 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. Notwithstanding any other law, the acquisition record created by a participating entity may be used as the donation, destruction, or disposition record required of a donor organization for donated medication.
(k)CA Health & Safety Code § 150204.6(k) Local and county protocols established pursuant to this division shall conform to the Pharmacy Law regarding packaging, transporting, storing, and dispensing all medications.
(l)CA Health & Safety Code § 150204.6(l) County protocols established for packaging, transporting, storing, and dispensing medications that require refrigeration, including, but not limited to, a biological product as defined in Section 351 of the federal 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.
(m)CA Health & Safety Code § 150204.6(m) Notwithstanding any other law, a participating entity shall follow the same federal and state procedural drug pedigree requirements for donated drugs as it would follow for drugs purchased from a wholesaler or directly from a drug manufacturer.
(n)CA Health & Safety Code § 150204.6(n) On January 1, 2028, the California State Board of Pharmacy shall submit to the Legislature an evaluation of the regional pilot programs and pilot participants’ compliance to program requirements as specified in this division. The report shall comply with Section 9795 of the Government Code.
(o)CA Health & Safety Code § 150204.6(o) A participating entity shall disclose to the California State Board of Pharmacy any “medication errors,” as that term is described in Section 1716 of Title 16 of the California Code of Regulations, arising out of a program under this division, within 30 days of a participating entity discovering the medication error.
(p)CA Health & Safety Code § 150204.6(p) This section shall remain in effect only until January 1, 2030, and as of that date is repealed.

Section § 150205

Explanation

This law states that certain people and entities, like drug manufacturers, pharmacists, physicians, and specific facilities, are protected from being sued if someone gets hurt from prescription drugs, as long as they are donated, accepted, or distributed according to the rules in this division.

Additionally, intermediaries that help collect and distribute surplus medications are also shielded from liability when doing so in line with the rules.

(a)CA Health & Safety Code § 150205(a) The following persons and entities shall not be subject to criminal or civil liability for injury caused when any entity or person donates, accepts, or dispenses prescription drugs in compliance with this division:
(1)CA Health & Safety Code § 150205(a)(1) A prescription drug manufacturer, wholesaler, governmental entity, or participating entity.
(2)CA Health & Safety Code § 150205(a)(2) A pharmacist or physician who accepts or dispenses prescription drugs.
(3)CA Health & Safety Code § 150205(a)(3) A licensed facility, as described in Section 150202, or a pharmacy, as described in Section 150202.5.
(b)CA Health & Safety Code § 150205(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.

Section § 150206

Explanation

If someone does not follow the rules, acts in bad faith, or is extremely careless, they are not protected by the legal safeguards mentioned in Section 150205.

The immunities provided in Section 150205 shall not apply in cases of noncompliance with this division, bad faith, or gross negligence.

Section § 150207

Explanation

This section states that the rules in this specific division do not change or interfere with any disciplinary actions that licensing and regulatory agencies have taken.

Nothing in this division shall affect disciplinary actions taken by licensing and regulatory agencies.

Section § 150208

Explanation

This law allows certain organizations, called surplus medication collection and distribution intermediaries, to help in transferring medications between approved groups. These intermediaries are not allowed to physically handle the drugs but must notify relevant parties when shipments occur. They cannot choose which group gets the medications; that decision is not theirs. They can, however, charge reasonable fees and work with counties to support medication donation programs. It's important to note that these organizations cannot directly give medication to any participating group.

(a)CA Health & Safety Code § 150208(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)CA Health & Safety Code § 150208(b) A surplus medication collection and distribution intermediary shall comply with the following:
(1)CA Health & Safety Code § 150208(b)(1) It shall not take possession, custody, or control of dangerous drugs and devices.
(2)CA Health & Safety Code § 150208(b)(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)CA Health & Safety Code § 150208(b)(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)CA Health & Safety Code § 150208(c) A surplus medication collection and distribution intermediary is authorized to do the following:
(1)CA Health & Safety Code § 150208(c)(1) Charge membership, administrative, or overhead fees sufficient to cover the reasonable costs of the support and services provided.
(2)CA Health & Safety Code § 150208(c)(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)CA Health & Safety Code § 150208(d) No participating entities shall receive donated medication directly from the surplus medication collection and distribution intermediary.