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§ 1776.5. Reverse Distributors.

16 CA ADC § 1776.5Barclays Official California Code of Regulations

Barclays California Code of Regulations
Title 16. Professional and Vocational Regulations
Division 17. California State Board of Pharmacy (Refs & Annos)
Article 9.1. Prescription Drug Take-Back Services
16 CCR § 1776.5
§ 1776.5. Reverse Distributors.
(a) A licensed reverse distributor (either a reverse wholesaler or a reverse third-party logistics provider) registered with the DEA may accept the sealed inner liners of collection receptacles at the reverse distributor's registered location by common or contract carrier pick-up, or by reverse distributor pick-up at the collector's authorized collection location. Once received, the reverse distributor shall establish records required by this section.
(b) A licensed reverse distributor may not open, survey, or otherwise analyze the contents of inner liners. All liners shall be destroyed by an appropriately licensed and registered DEA reverse distributor in a manner that makes the drugs irretrievable.
(c) If a reverse distributor picks up the sealed inner liners from the collector's authorized location, at least two employees of the reverse distributor shall be present. If the sealed inner liners are delivered to the reverse distributor via common or contract carrier, at least one employee of the reverse distributor shall accept the receipt of the inner liners at the reverse distributor's registered location.
(d) A reverse distributor shall not employ as an agent or employee anyone who has access to or influence over controlled substances, any person who has been convicted of any felony offense related to controlled substances or who at any time had a DEA registration revoked or suspended, or has surrendered a DEA registration for cause.
(e) For each sealed liner or mail back envelopes or packages received pursuant to federal Title 21 CFR section 1317.55, the reverse distributor shall maintain records of the number of sealed inner liners or mail back envelopes or packages, including the:
(1) Date of acquisition;
(2) Number and the size (e.g., five 10-gallon liners, etc.);
(3) Unique Identification number of each liner or envelope/package;
(4) The method of delivery to the reverse distributor, the signature of the individuals delivering the liners to the reverse distributor, and the reverse distributor's employees who received the sealed liner;
(5) The date, place and method of destruction;
(6) Number of packages and inner liners received;
(7) Number of packages and inner liners destroyed;
(8) The name and signature of the two employees of the registrant that witnessed the destruction.
(e) For liners only, the information specified in subsection (e)(1)-(8) above shall be created at the time of receipt and at the time of destruction.

Credits

Note: Authority cited: Section 4005, Business and Professions Code. Reference: Section 4005, Business and Professions Code; and Section 1301.71, 1304.21, 1304.22, 1317.15, 1317.55 and 1317.95, Title 21, Code of Federal Regulations.
History
1. New section filed 6-6-2017; operative 6-6-2017 pursuant to Government Code section 11343.4(b)(3) (Register 2017, No. 23).
This database is current through 5/10/24 Register 2024, No. 19.
Cal. Admin. Code tit. 16, § 1776.5, 16 CA ADC § 1776.5
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