Duane Morris Alert

On June 9, 2016, the U.S. Food and Drug Administration (“FDA”) published two final guidance documents on drug compounding under Sections 503A and 503B of the Food, Drug, and Cosmetic Act (“FDCA”).[1] These guidance documents cover two topics:

Authors: Emily L. Hussey

Type: Articles Published

  • Interim Policy On Compounding Using Bulk Substances Under Section 503A
  • Interim Policy On Compounding Using Bulk Substances Under Section 503B

Through these topics, the FDA provides further insight into its current thinking on certain areas of drug compounding.

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