Or. Admin. Code § 855-139-0100

Current through Register Vol. 63, No. 11, November 1, 2024

Section 855-139-0100 - Security

(1) The area in a registered RDSP where legend and/or controlled substances are stored, possessed, prepared, compounded or repackaged must be restricted in access by utilizing physical barriers to include floor to ceiling walls and a locked separate entrance to ensure the security of those drugs.

(2) The RDSP Affiliated Pharmacy, the RDSP, Oregon licensed Pharmacist-in-charge of the RDSP Affiliated Pharmacy and each Oregon licensed Pharmacist supervising the RDSP is responsible for the security of the prescription area including provisions for adequate safeguards against loss, theft or diversion of prescription drugs, and records for such drugs.

(3) The RDSP must be locked and the alarm system armed to prevent, deter and detect entry when:

(a) There is no Oregon licensed Pharmacist from the RDSP Affiliated Pharmacy actively supervising the RDSP; or

(b) There is no Certified Oregon Pharmacy Technician or Pharmacy Technician present in the RDSP; or

(c) Any component of the surveillance system is not functioning.

(4) A record must be maintained with the name and license number of each person entering the pharmacy area of the RDSP.

(5) No one may be in the prescription area of a RDSP unless authorized in real-time by an Oregon licensed Pharmacist who is supervising the RDSP and from the RDSP Affiliated Pharmacy.

(6) Minimum security methods must include a properly functioning:

(a) Alarm system at the RDSP and real-time notification to a designated licensee of the RDSP Affiliated Pharmacy if unauthorized access occurs;

(b) Electronic entry system that is controlled by an Oregon licensed Pharmacist and records the:

(A) Identification of the Oregon licensed Pharmacist authorizing access and securing the RDSP;

(B) Identification of the Certified Oregon Pharmacy Technician or Pharmacy Technician accessing and securing the RDSP; and

(C) Date and time of each activity.

(c) Surveillance system that utilizes continuously accessible and recorded video between the RDSP Affiliated Pharmacy and the RDSP. The system must provide a clear view of:

(A) Dispensing site entrances;

(B) Preparation areas;

(C) Drug storage areas;

(D) Pick up areas;

(E) Office areas; and

(F) Publicly accessible areas.

Or. Admin. Code § 855-139-0100

BP 43-2021, adopt filed 12/16/2021, effective 1/1/2022; BP 17-2022, amend filed 04/20/2022, effective 4/20/2022; BP 26-2022, temporary amend filed 04/22/2022, effective 4/22/2022 through 10/18/2022; BP 36-2022, amend filed 06/15/2022, effective 6/16/2022

Statutory/Other Authority: ORS 475.035, ORS 689.205 & 2022 HB 4034

Statutes/Other Implemented: ORS 689.155 & 2022 HB 4034