California Code, Health and Safety Code - HSC § 150204.6
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(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) 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 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) 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 each ensure that this notice is also provided to the other two entities.
(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) 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) 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 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)(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 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) 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.
(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 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) 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) 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) 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) 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) 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) 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) 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) Local and county protocols established pursuant to this division shall conform to the Pharmacy Law regarding packaging, transporting, storing, and dispensing all medications.
(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) 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) On January 1, 2028, the 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) A participating entity shall disclose to the 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) This section shall remain in effect only until January 1, 2030, and as of that date is repealed.
Cite this article: FindLaw.com - California Code, Health and Safety Code - HSC § 150204.6 - last updated January 01, 2023 | https://codes.findlaw.com/ca/health-and-safety-code/hsc-sect-150204-6/
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