Or. Admin. Code § 855-143-0200

Current through Register Vol. 63, No. 10, October 1, 2024

Section 855-143-0200 - Outlet: General Requirements

(1) The PPL Affiliated Pharmacy and its PIC are responsible for all operations and enforcing all policies and procedures of the PPL.

(2) A PPL Affiliated Pharmacy may operate more than one PPL.

(3) A PPL Affiliated Pharmacy must be less than 120 miles apart via the shortest surface street route from the PPL.

(4) A PPL and its PPL Affiliated Pharmacy must:

(a) Have the same owner; or

(b) Have a written contract that specifies:

(A) The services to be provided by each licensee and registrant;

(B) The responsibilities of each licensee and registrant; and

(C) The accountabilities of each licensee and registrant;

(c) Ensure each prescription and non-prescription drugs, devices, and related supplies are dispensed in compliance with OAR 855-041, OAR 855-115, OAR 855-120, OAR 855-125 and OAR 855-143;

(d) Ensure that the PPL Affiliated Pharmacy prevents duplicate dispensing of a prescription;

(e) Comply with all applicable federal and state laws and rules;

(f) Ensure that PPL Affiliated Pharmacy has received and documented consent by the patient or patient's agent for the patient's prescription and non-prescription drugs, devices, and related supplies to be placed in the PPL;

(g) Ensure that there is an Oregon licensed PIC who is responsible for all operations and enforcing all policies and procedures of the PPL;

(h) Designate in writing the Oregon licensed Pharmacists, Interns, Pharmacy Technicians and Certified Oregon Pharmacy Technicians authorized to access the PPL;

(i) Utilize complete chain of custody tracking;

(j) Train the Oregon licensed Pharmacists, Interns, Pharmacy Technicians and Certified Oregon Pharmacy Technicians in the operation of the PPL and document the training;

(k) Develop, implement and enforce a continuous quality improvement program for dispensing services from a PPL designed to objectively and systematically:

(A) Monitor, evaluate, document the quality and appropriateness of patient care;

(B) Improve patient care; and

(C) Identify, resolve and establish the root cause of dispensing and DUR errors and prevent their reoccurrence;

(l) Provide a telephone number that a patient, patient's agent or prescriber may use to contact the Oregon licensed Pharmacist from the PPL Affiliated Pharmacy; and

(m) Develop, implement and enforce a process for an in person physical inspection of the PPL by an Oregon licensed Pharmacist at least once every 28 days or more frequently as deemed necessary by the Oregon licensed PIC of the PPL Affiliated Pharmacy. The inspection must utilize the PPL self-inspection form, be documented, and records retained.

Or. Admin. Code § 855-143-0200

BP 21-2022, adopt filed 04/20/2022, effective 4/20/2022; BP 38-2024, minor correction filed 04/10/2024, effective 4/10/2024

Statutory/Other Authority: ORS 689.205

Statutes/Other Implemented: ORS 689.155 & ORS 689.527