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Safety Standards in Pharmaceutical Compounding, Part 2: A Closer Look at Agency Information, Oversight, and Assistance

Author(s):  Greeson Nicole MH, Mixon William, Allan W Chris

Issue:  Sep/Oct 2020 - Volume 24, Number 5
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Abstract:  In the U.S., compounding pharmacies are regulated primarily by state boards of pharmacy, which often collaborate with federal agencies such as the Drug Enforcement Administration or the Department of Health and Human Services. Other organizations, such as the U.S. Food and Drug Administration, the Occupat ional Safety and Health Administration, the Environmental Protection Agency, and state departments of agriculture or labor may also have jurisdiction over compounding pharmacies and their employees. In addition, compounding pharmacies are subject to the requirements of Section 503A of the Federal Food, Drug, and Cosmetic Act. Complying with requirements for training and competency and documenting adherence to various agency regulations may seem daunting, but guidance in doing so is available from independent organizations such as the United States Pharmacopeial Convention, Inc., and the Pharmacy Compounding Accreditation Board. In this second article in a series on safety standards in pharmaceutical compounding, we discuss the roles of several of those influential federal organizations and the benefits that guidance from independent agencies provides for compounding pharmacists. Questions of interest to pharmacists who seek to comply with established agency safety standards are also answered.

Related Keywords: Nicole M.H. Greeson, MS, CIH, William Mixon, RPh, MS, FIACP, FACA, W. Chris Allan, MPA, government agencies, state agencies, pharmacy regulation, state boards of pharmacy, drug safety standards, US Food and Drug Administration, FDA, National Institute for Occupational Safety and Health, NIOSH, Occupational Safety and Health Administration, OSHA, Environmental Protection Agency, EPA, United States Pharmacopeial Convention, Inc., USP, Pharmacy Compounding Accreditation Board, PCAB, chemical inventory list, personal protective equipment, PPE, hazardous chemicals


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