Cal. Code Regs. tit. 16 § 1776.1

Current through Register 2024 Notice Reg. No. 45, November 8, 2024
Section 1776.1 - Pharmacies
(a) Pharmacies may provide take-back services to the public. Retail pharmacies and hospital/clinics with onsite pharmacies may maintain collection receptacles in their facilities. Pharmacies may offer drug take-back services as specified in section 1776.4 in skilled nursing facilities licensed under Health and Safety Code section 1250(c).
(b) There are multiple federal, state and local requirements governing the collection and destruction of dangerous drugs. Pharmacies are expected to know and adhere to these requirements when operating a prescription drug take-back program.
(c) For purposes of this article, prescription drugs means dangerous drugs as defined by Business and Professions Code section 4022, which includes controlled substances. Controlled substances may be commingled in collection receptacles or mail back envelopes or packages with other dangerous drugs.
(d) Once drugs are deposited into a collection receptacle or mail back envelopes or packages by a consumer, they are not to be removed, counted, sorted or otherwise individually handled.
(e) The collection receptacle shall contain signage that includes:
(1) The name and phone number of the responsible pharmacy;
(2) Medical sharps and needles (e.g., insulin syringes) shall not be deposited; and
(3) Consumers may deposit prescription drugs including Schedule II-V controlled substances.
(f) Prescription drugs that are eligible for collection as part of drug take-back services maintained by pharmacies are only those prescription drugs that have been dispensed by any pharmacy or practitioner to a consumer. Dangerous drugs that have not been dispensed to consumers for use (such as outdated drug stock in a pharmacy, drug samples provided to a medical practitioner or medical waste) may not be collected as part of a pharmacy's drug take-back service.
(g) As part of its drug take-back services, a pharmacy shall not:
(1) Review, accept, count, sort, or otherwise individually handle any prescription drugs from consumers.
(2) Accept or possess prescription drugs from skilled nursing facilities, residential care homes, health care practitioners or any other entity.
(3) Dispose of quarantined, recalled or outdated prescription drugs from pharmacy stock.
(h) A pharmacy must be registered with the federal DEA as a collector for purposes of maintaining a prescription drug take-back collection receptacle. Such pharmacies cannot employ anyone convicted of a felony related to controlled substances, or anyone who has had a DEA permit denied, surrendered or revoked.
(i) Any pharmacy that maintains a drug take-back collection receptacle as authorized in this article shall notify the board in writing within 30 days of establishing the collection program. Additionally:
(1) Any pharmacy that ceases to maintain a drug take-back collection receptacle shall notify the board in writing within 30 days.
(2) Any pharmacy maintaining a collection receptacle shall disclose to the board that it provides such services annually at the time of renewal of the pharmacy license, and shall identify all locations where its collection receptacles are located.
(3) Any tampering with a collection receptacle or theft of deposited drugs shall be reported to the board in writing within 14 days.
(4) Any tampering, damage or theft of a removed liner shall be reported to the board in writing within 14 days.
(j) If the pharmacy ceases to maintain a registered collection receptacle, the pharmacy must notify the DEA within 30 days.
(k) A pharmacy shall not provide take-back services to consumers if, in the professional judgment of the pharmacist-in-charge, the pharmacy cannot comply with the provisions of this article or the DEA rules.
(l) A pharmacy shall not provide take-back services to consumers if the pharmacy or the pharmacist-in-charge is on probation with the board, and, if the pharmacy had previously provided take-back services, the pharmacist-in-charge shall notify the board and the DEA as required in subsections (i) and (j), above.

Cal. Code Regs. Tit. 16, § 1776.1

1. New section filed 6-6-2017; operative 6-6-2017 pursuant to Government Code section 11343.4(b)(3) (Register 2017, No. 23).

Note: Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4005 and 4022, Business and Professions Code; and Sections 1301.71, 1317.30 and 1317.40, Title 21, Code of Federal Regulations.

1. New section filed 6-6-2017; operative 6/6/2017 pursuant to Government Code section 11343.4(b)(3) (Register 2017, No. 23).