H-120.945 AMA Action on Non FDA-Approved Compounded Medications

Our American Medication Association:

1. recognizes that compounding pharmacies must comply with current United States Pharmacopeia and National Formulary (USP-NF) compounding monographs, when available, and recommends that they be required to conform with USP-NF General Chapters on pharmaceutical compounding to ensure the uniformity, quality, and safety of compounded medications;
2. recognizes the accreditation program of the Pharmacy Compounding Accreditation Board (PCAB™) and the PCAB™ Seal of Accreditation as a means to identify compounding pharmacies that adhere to quality and practice standards, including those set forth in the USP-NF, for the preparation of individualized medications for specific patients;
3. encourages all state boards of pharmacy to require compounding pharmacies in their states to obtain the PCAB™ Seal of Accreditation or, alternatively, to satisfy comparable standards that have been promulgated by the state in its laws and regulations governing pharmacy practice; and
4. encourages state boards of pharmacy and the National Association of Boards of Pharmacy (NABP), the umbrella organization for state boards of pharmacy, to work with the United States Food and Drug Administration (FDA) to identify and take appropriate enforcement action against entities that are illegally manufacturing medications under the guise of pharmacy compounding. (BOT Action in response to referred for decision Res. 521, A-06)

American Medical Association: http://www.ama-assn.org/