Or. Admin. Code § 855-141-0100

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

Section 855-141-0100 - Security

(1) The PPK Affiliated Pharmacy, the PPK, PIC of the PPK Affiliated Pharmacy and each Pharmacist supervising the PPK is responsible for the security of the PPK including provisions for adequate safeguards against loss, theft or diversion of prescription and non-prescription drugs, devices, and related supplies, and records for such drugs, devices and related supplies.

(2) The PPK Affiliated Pharmacy must ensure the PPK:

(a) Is placed in a secure indoor location that is climate controlled and protected from the elements;

(b) Is securely fastened to a permanent structure so that it cannot be removed;

(c) Stores prescription and non-prescription drugs, devices, and related supplies in compliance with the provisions of OAR 855-141-0125;

(3) The PPK must be secured to prevent access when:

(a) There is no Pharmacist supervising and authorizing access in real-time to the PPK; or

(b) There is no Pharmacist, Intern, Certified Oregon Pharmacy Technician or Pharmacy Technician employed by the PPK Affiliated Pharmacy present at the PPK; or

(c) Any component of the PPK is not functioning.

(4) A record must be maintained with the name and Oregon license number of each person accessing the PPK.

(5) An Intern, Certified Oregon Pharmacy Technician, and Pharmacy Technician must only access the PPK when a Pharmacist is supervising the licensee and has authorized access to the PPK in real-time.

(6) Unlicensed personnel (e.g. service or repair personnel) must only access the PPK when escorted and continuously observed by a licensee who is authorized by the Pharmacist who is supervising and authorizing access to the PPK in real-time.

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

(a) Alarm system at the PPK and real-time notification to a Pharmacist from the PPK Affiliated Pharmacy if unauthorized access occurs;

(b) Electronic entry system that is controlled by a Pharmacist and records the:

(A) Identification of the Pharmacist authorizing each access and securing the PPK;

(B) Identification of the Pharmacist, Intern, Certified Oregon Pharmacy Technician or Pharmacy Technician accessing and securing the PPK; and

(C) Date and time of each activity; and

(c) Surveillance system that utilizes continuously accessible and recorded video between the PPK Affiliated Pharmacy and the PPK. The system must provide a clear view of the entire PPK including its access points.

Or. Admin. Code § 855-141-0100

BP 50-2022, adopt filed 12/20/2022, effective 2/15/2023

Statutory/Other Authority: ORS 689.205

Statutes/Other Implemented: ORS 689.155, ORS 689.527