Or. Admin. Code § 855-143-0100

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

Section 855-143-0100 - Security

(1) The PPL Affiliated Pharmacy, the PPL, Oregon licensed PIC of the PPL Affiliated Pharmacy and each Oregon licensed Pharmacist supervising the PPL is responsible for the security of the PPL 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 PPL Affiliated Pharmacy must ensure the PPL:

(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 855-143-0125;

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

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

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

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

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

(5) An Intern, Certified Oregon Pharmacy Technician, and Pharmacy Technician may only access the PPL when an Oregon licensed Pharmacist is supervising the licensee and has authorized access to the PPL in real-time.

(6) Unlicensed personnel (e.g. vendor) may only access the PPL when escorted and continuously observed by a licensee who is authorized by the Oregon licensed Pharmacist who is supervising and authorizing access to the PPL in real-time.

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

(a) Alarm system at the PPL and real-time notification to an Oregon licensed Pharmacist of the PPL 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 PPL;

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

(C) Date and time of each activity; and

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

Or. Admin. Code § 855-143-0100

BP 21-2022, adopt filed 04/20/2022, effective 4/20/2022

Statutory/Other Authority: ORS 689.205

Statutes/Other Implemented: ORS 689.155 & ORS 689.527