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Sterile Compounding Pharmacies: States That Do and Do Not Require Compliance With USP <797> Versus FDA 483s

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Abstract

Traditional pharmacy compounding involves the modification of a dosage form to fit the needs of a patient, as prescribed by the patient’s physician, and serves a vital need within the health community. Unites States Pharmacopeia–National Formulary (USP-NF) General Chapter <797>, titled “Pharmaceutical Compounding—Sterile Preparations,” is the gold standard to which modern-day pharmacists compounding sterile products are held. In this article, the FDA 483 inspection reports received by sterile compounding pharmacies were divided into 2 categories: facilities in the United States that require compliance with USP <797> and those that do not require compliance with USP <797>. Results revealed no association between the number or category of 483 comments and state requirements to comply with USP <797>. The impact of voluntary registration of compounding pharmacies with FDA in accordance with the 2013 Drug Quality and Security Act (DQSA) has yet to be determined. The author recommends a national database of all pharmacy compounding facilities that lists the types of manufacturing in each facility to increase transparency and target audits, as well as the institution of rewards for quality in the generic industry to help avoid drug shortages.

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Authors and Affiliations

  1. Expert Regulatory Strategist, Virtual Regulatory Solutions Inc, PO Box 28, Hamilton, OH, 45012, USA

    Michelle Wilson PhD

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  1. Michelle Wilson PhD
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Correspondence to Michelle Wilson PhD.

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Wilson, M. Sterile Compounding Pharmacies: States That Do and Do Not Require Compliance With USP <797> Versus FDA 483s. Ther Innov Regul Sci 50, 279–303 (2016). https://doi.org/10.1177/2168479016636417

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  • DOI: https://doi.org/10.1177/2168479016636417

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