SECTIONS 150200-150207 - California Statutes

HEALTH AND SAFETY CODE

SECTION 150200-150207

150200. 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.

150201. For purposes of this division, "medication" or "medications"
means a dangerous drug, as defined in Section 4022 of the Business
and Professions Code.

150202. Notwithstanding any other provision of law, a licensed
skilled nursing facility, as defined in Section 1250, including a
skilled nursing facility designated as an institution for mental
disease, may donate unused medications under a program established
pursuant to this division.

150203. 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.

150204. (a) A county may establish, by ordinance, a repository and
distribution program for purposes of this division. Only pharmacies
that are county-owned or that contract with the county pursuant to
this division may participate in this program to dispense medication
donated to the drug repository and distribution program.
(b) A county that elects to establish a repository and
distribution program pursuant to this division shall establish
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 county-owned or
county-contracted, licensed pharmacy.
(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 skilled nursing facility, shall have been
under the control of staff of the skilled nursing facility.
(d) 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.
(e) A pharmacist 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 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 any of the following ways:
(1) Dispensed to an eligible patient.
(2) Destroyed.
(3) Returned to a reverse distributor.
(h) Medication that is donated to the repository and distribution
program that does not meet the requirements of this division shall
not be distributed 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 pharmacy's other drug stock by physical
means, for purposes including, but not limited to, inventory,
accounting, and inspection.
(k) The pharmacy shall keep complete records of the acquisition
and disposition of medication donated to and dispensed under the
repository and distribution program. These records shall be kept
separate from the pharmacy'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 and Service Act (42 U.S.C. Sec.
262), an intravenously injected drug, or an infused drug, include
specific procedures to ensure that these medications are packaged,
transported, stored, and dispensed at their appropriate temperatures
and in accordance with USP standards and the Pharmacy Law.
(n) Notwithstanding any other provision of law, a participating
county-owned or county-contracted pharmacy 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.

150205. 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:
(a) A prescription drug manufacturer, wholesaler, governmental
entity, county-owned or county-contracted licensed pharmacy, or
skilled nursing facility.
(b) A pharmacist or health care professional who accepts or
dispenses prescription drugs.

150206. The immunities provided in Section 150205 shall not apply
in cases of noncompliance with this division, bad faith, or gross
negligence.

150207. Nothing in this division shall affect disciplinary actions
taken by licensing and regulatory agencies.