White Papers

Top 3 Strategies for Complying with USP <795> & USP <797>

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White Paper 1 MasterControl eTMF Manager | Go Beyond Document Management In the aftermath of a fungal meningitis outbreak in the United States 1 , the compounding industry is facing a regulatory landscape that has changed drastically. The U.S. Congress passed the Drug Quality and Security Act (H.R. 3204) to amend Section 503A of the Federal Food, Drug, and Cosmetic Act. 2 The bill clarifies the authority of the U.S. Food and Drug Administration (FDA) over compounding pharmacies that act as "outsourcing facilities," a term referring to companies that produce sterile compounded preparations in certain quantities, usually to anticipate needs of patients, which are shipped in interstate commerce. The Drug Quality and Security Act covers compounded formulations that comply with USP <795> and USP <797>, the guidelines designed to help ensure quality compounded preparations and patient safety. This white paper will discuss common compliance issues and offer effective strategies for compliance. 4 Common Compliance Issues Under the Drug Quality and Security Act, outsourcing facilities can register with the FDA on a voluntary basis and submit reports twice a year to identify compounded formulations they produce. Companies that register will be subject to inspections, cGMP compliance, labeling, adverse event reporting requirements, and user fees 3 . Under the bill, traditional compounding pharmacies (small operations that produce compounded formulations based on specific patient prescriptions) will remain under the jurisdiction of state pharmacy boards and remain exempt from FDA's manufacturing authority. Whether your company is a traditional compounding pharmacy or one that falls under the FDA's definition of an outsourcing facility, the key to compliance with USP <795> and USP <797> is quality control. A majority of compounding pharmacies that have received Form FDA-483s (list of inspection observations) and warning letters recently were cited for quality-related issues. Outside of violations pertaining to cleanliness and adequacy or appropriateness of equipment and facilities, here are some of the common quality issues cited in FDA Form 483s: Corrective Action and Preventive Action Issues: In a 483 to a company that voluntarily recalled its compounded formulation, the FDA cited a lack of CAPA investigation, saying: "No investigations were conducted for any of the failed lots." It also noted that "no root cause was identified." 4 Similarly, the FDA noted in another case that the company failed to investigate potency failures of failed batches and failed to determine the root cause of the problem 5 .

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