FDA Guidance On Compounded Drugs That Are Essentially Copies Of Commercially Available Drugs

To qualify for the exemptions from certain requirements of the Food, Drug and Cosmetics Act (“FDCA”), compounded drugs may not be “essentially copies of commercially available drug products.” On January 18, 2018, the FDA issued new guidance for both traditional 503A compounding pharmacies and 503B outsourcing facilities on the interpretation the term “essentially copies of commercially available drug products” and how it intends to ensure compliance.  The FDCA provides that the term “‘essentially a copy of a commercially available drug product’ does not include a drug product in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug.”  Sec. 502(A)(b)(2).

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Posted in: Pharmacy Law & Regulation