OAR 855-183-0015. Requirements: General

(1) All drug compounding must adhere to the following standards of the United States Pharmacopeia (USP) and the National Formulary (NF) including: (a) USP <795> Pharmaceutical Compounding- Non-Sterile Preparations (11/01/2023); (b) USP <797> Pharmaceutical Compounding - Sterile Preparations (02/01/2026); (c) USP <800> Hazardous Drugs - Handling in Healthcare Settings (11/01/2023); and (d) USP <825> Radiopharmaceuticals - Preparation, Compounding, Dispensing, and Repackaging (01/01/2024). (2) In addition to completing the appropriate drug outlet self-inspection form by July 1 of each year and within 15 days of becoming the Pharmacist-in-Charge (PIC), the PIC must also complete the Compounding Self-Inspection form provided by the board. (3) All compounding records must be maintained for 3 years in accordance with OAR 855-104-0055. (4) A pharmacist for a pharmacy or prescriber with prescribing and dispensing privileges for a Dispensing Practitioner Drug Outlet, Correctional Facility or Community Health Clinic must; (a) Supervise compounding; (b) Ensure only authorized personnel are in the compounding area; and (c) Verify and document verification of all compounded products, compounding records and master formulation records. (5) Comply with all state and federal laws and rules. (6) Effective November 1, 2027, Non-Resident Drug Outlets that prepare compounded products must be inspected and be in compliance with current USP standards. If a Drug Outlet’s home state does not inspect and require compliance with current USP standards, the Drug Outlet, prior to obtaining or renewing a license, must provide evidence to the board that the Drug Outlet is accredited, certified or received an approved inspection within the last two years as follows: (a) Pharmacy Compounding Accreditation Board (PCAB) provided by the Accreditation Commission for Health Care (ACHC); (b) Coalition for Compounding Excellence (CCE); (c) National Association of Boards of Pharmacy (NABP); (d) The Joint Commission; or (e) As otherwise approved by the board. (7) The following is prohibited in the compounding area: (a) Animal(s); and (b) For non-sterile compounding, flooring that is not easily cleanable, is porous or particle generating. [Publications: Publications referenced are available for review at the agency or from the United States Pharmacopoeia.]