Or. Admin. R. 855-041-1060

Current through Register Vol. 63, No. 8, August 1, 2024

Section 855-041-1060 - Non-Resident Pharmacies

(1) For the purpose of these rules, a non-resident pharmacy is any establishment located out of Oregon that engages in the dispensing, delivery or distribution of drugs to Oregon. A non-resident pharmacy also includes entities that provide pharmacy services to Oregon, such as drugless/consulting outlets, even if the entity is not dispensing, delivering or distributing drugs into Oregon.

(2) Every non-resident pharmacy that provides drugs, devices or services to a resident in this state must be registered with the Oregon Board of Pharmacy.

(3) To qualify for registration under these rules, every non-resident pharmacy must be registered and in good standing with the Board of Pharmacy in the pharmacy's state of residence.

(4) Every out-of-state non-resident pharmacy must designate an Oregon licensed Pharmacist-in-Charge (PIC), who must be responsible for all pharmacy services provided to residents in Oregon, and to provide supervision and control in the pharmacy. To qualify for this designation, the person must:

(a) Hold a license to practice pharmacy in the resident state;

(b) Be normally present in the pharmacy for a minimum of 20 hours per week;

(c) Annually complete a self-inspection form using the board's Non-Resident Retail Drug Outlet Self-Inspection Form prior to July 1; and

(d) Provide the PIC Self-Inspection Form as requested by the board.

(5) Every non-resident pharmacy will have a pharmacist-in-charge (PIC) who is licensed in Oregon within four months of initial licensure of the pharmacy.

(6) When a change of Pharmacist-in-Charge (PIC) occurs, the non-resident pharmacy will notify the board within ten business days and identify a contact person. The pharmacy will have an Oregon licensed PIC employed within 90 days. The contact person must be a licensed pharmacist in the pharmacy's state of residence and is responsible for the following:

(a) Supervision of pharmacy staff and ensuring compliance with laws and rules; and

(b) Responding to board correspondence and inquiries.

(7) A new Pharmacist-in-Charge must be appointed, and communication made to the board within 90 days, or the non-resident pharmacy will cease drug distribution and provision of pharmacy services in Oregon.

Or. Admin. R. 855-041-1060

PB 1-1994, f. & cert. ef. 2-2-94; BP 2-2008, f. & cert. ef. 2-20-08; Renumbered from 855-041-0300, BP 7-2012, f. & cert. ef. 12-17-12; BP 4-2015, f. & cert. ef. 7/1/2015; BP 37-2021, amend filed 12/16/2021, effective 12/16/2021; BP 12-2023, amend filed 06/13/2023, effective 8/1/2023; BP 34-2023, amend filed 12/19/2023, effective 3/1/2024

Statutory/Other Authority: ORS 689.205

Statutes/Other Implemented: ORS 689.151, ORS 689.155 & ORS 689.225