Or. Admin. Code § 855-139-0460

Current through Register Vol. 63, No. 12, December 1, 2024

Section 855-139-0460 - Drugs and Devices: Take-back Program

(1) A RDSP that operates a drug take-back collection program or that participates in a drug take-back program under ORS 459A.200 to ORS 459A.266 as an authorized collector must be registered with the DEA as an authorized collector to collect controlled and non-controlled drugs for destruction.

(2) A RDSP that operates as a Drug Enforcement Agency (DEA) authorized collector must notify the board within 30 days of initiating or terminating the program and must establish and enforce policies and procedures, including but not limited to:

(a) Provision of a secure location of the collection receptacle inside the retail drug outlet, which is accessible to the public, within view of the pharmacy counter and must not be located behind the pharmacy counter; and

(b) Provision of adequate security measures, including proper installation and maintenance of the collection receptacle, tracking of liners, documentation, and key accountability; and

(c) Personnel training and accountability.

(3) A RDSP must inform consumers to directly deposit drugs into the collection receptacle. Pharmacy personnel must not count, sort, inventory, or otherwise handle drugs collected.

(4) A RDSP must not dispose of drugs from pharmacy stock in a collection receptacle.

(5) The liner must be inserted and removed from a locked collection receptacle only by or under the supervision of two employees of the pharmacy. Upon removal, the liner must be immediately sealed, and the pharmacy employees must document their participation in the insertion and removal of each liner from a collection receptacle on a log. Sealed liners must not be opened, analyzed, or penetrated at any time by the pharmacy or pharmacy personnel.

(6) Liners that have been removed from a collection receptacle and immediately sealed must be directly transferred, or otherwise stored in a secured, locked location in the pharmacy for no longer than 14 days prior to being transferred, by two pharmacy personnel to a registered drug distribution agent (such as registered UPS, FedEx, or USPS) or a reverse wholesaler registered with the DEA and the board.

(7) Any tampering with a collection receptacle, liner or theft of deposited drugs must be reported to the board in writing within one day of discovery.

(8) A RDSP must maintain all drug disposal records for a minimum of 3 years.

(9) Authorized collectors are required to comply with the following federal and state laws:

(a) ORS 459A.200, ORS 459A.203, ORS 459A.206, ORS 459A.209, ORS 459A.212, ORS 459A.215, ORS 459A.218, ORS 459A.221, ORS 459A.224, ORS 459A.227, ORS 459A.230, ORS 459A.233, ORS 459A.236, ORS 459A.239, ORS 459A.242, ORS 459A.245, ORS 459A.248, ORS 459A.251, ORS 459A.254, ORS 459A.257, ORS 459A.260, ORS 459A.263, and ORS 459A.266;

(b) OAR 340-098-0000, OAR 340-098-0010, OAR 340-098-0300, OAR 340-098-0350, OAR 340-098-0370, and OAR 340-098-0390;

(c)21 CFR 1317.30 (04/01/2023), 21 CFR 1317.35 (04/01/2023), 21 CFR 1317.40 (04/01/2023), 21 CFR 1317.55 (04/01/2023), 21 CFR 1317.60 (04/01/2023), 21 CFR 1317.65 (04/01/2023), 21 CFR 1317.70 (04/01/2023), 21 CFR 1317.75 (04/01/2023), 21 CFR 1317.80 (04/01/2023), and 21 CFR 1317.85 (04/01/2023); and

(d)21 USC 822 (03/23/2024) and 21 USC 822a (03/23/2024).

Or. Admin. Code § 855-139-0460

BP 43-2021, adopt filed 12/16/2021, effective 1/1/2022; BP 27-2022, amend filed 06/15/2022, effective 6/16/2022; BP 10-2023, amend filed 06/13/2023, effective 6/13/2023; BP 57-2024, amend filed 06/18/2024, effective 6/20/2024

Publications: Publications referenced are available for review at the agency.

Statutory/Other Authority: ORS 689.205 & ORS 459A.266

Statutes/Other Implemented: ORS 689.305, ORS 459A.203, ORS 459A.215 & ORS 495A.218