Article, Compounding Remains an FDA Priority: Agency Announces 2018 ‘Compounding Priorities Plan’ and Several Compounding Guidances, Including Guidance on ‘Essentially Copies’ and Repackaging

March 27, 2018By: Karla Palmer Download PDF

In January, FDA announced the release of its 2018 “Compounding Priorities Plan.”1 FDA also released several guidance documents in the wake of its announcement, such as its final guidance on essentially copies of commercially available drug products for Section 503A and 503B facilities, and guidance on repackaging of biologic products outside of an approved BLA.

FDA notes that “Our 2018 compounding policy priorities plan lays out how the agency will implement certain key provisions of the Drug Quality and Security Act and other provisions of the law relevant to compounders over the course of the coming year. Our policy will be part of a series of draft and final guidance documents, proposed and final rules and a revised draft memorandum of understanding (MOU) between the FDA and the states.”

Article appeared in Mar. 13 edition of Westlaw Journal Pharmaceuticals.

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