Or. Admin. Code § 855-045-0220 - Personnel and Responsibilities

(1) All personnel who prepare and supervise the preparation of a compound must complete appropriate training and be capable and qualified to perform assigned duties.

(2) The Pharmacist-in-Charge (PIC) and the drug outlet must establish, maintain and enforce policies and procedures in accordance with the standards required in OAR 855-045-0200(3) for all aspects of the compounding operation according to the type of compounding performed and must include written procedures for:

(a) Personnel qualifications, to include training, evaluation and requalification;

(b) Hand hygiene;

(c) Garbing;

(d) Engineering and environmental controls, to include equipment certification and calibration, air and surface sampling, and viable particles;

(e) Cleaning activities, to include sanitizing and disinfecting, including those compounding personnel and other staff responsible for cleaning;

(f) Components, to include selection, handling, and storage;

(g) Creating master formulation records, with documented pharmacist approval;

(h) Creating compounding records;

(i) Establishing beyond-use dates (BUDs);

(j) Continuous quality assurance program and quality controls, to include release testing, end-product evaluation, and quantitative/qualitative testing;

(k) Completed compounded preparations, to include handling, packaging, storage and transport;

(l) Adverse event reporting process and recall procedure. The recall procedure must include notification to the board within 10 working days in the event of a patient-level recall of a compounded drug.

Notes

Or. Admin. Code § 855-045-0220

BP 2-2008, f. & cert. ef. 2-20-08; BP 3-2011, f. & cert. ef. 4-18-11; BP 12-2019, amend filed 12/20/2019, effective 12/20/2019; BP 45-2021, amend filed 12/16/2021, effective 12/16/2021; BP 12-2023, amend filed 06/13/2023, effective 8/1/2023

Statutory/Other Authority: ORS 689.205

Statutes/Other Implemented: ORS 689.155