OAR 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 shall establish, maintain and enforce policies and procedures in accordance with the standards in USP Chapters for all aspects of the compounding operation according to the type of compounding performed and shall 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.
Source:
Rule 855-045-0220 — Personnel and Responsibilities, https://secure.sos.state.or.us/oard/view.action?ruleNumber=855-045-0220.