Health Law Update

Home | Health Law Update

The Food and Drug Administration (FDA) recently announced a new docket for public comments on the compounding of human drug products under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FFDCA). The FDA hopes that these public comments will provide insight on stakeholders’ experience and views regarding drug compounding as the FDA implements these sections of the FFDCA.

While the FDA has previously requested public comments on quite a few particular compounding issues, stakeholders have expressed interest in providing comments to the FDA on issues that are not related to specific regulations, guidance documents or FDA notices. As such, this docket is intended to allow anyone to “share information, research, and ideas on any matters related to human drug compounding that are not specific to the documents or issues addressed in other dockets.”

The FDA issued a <a class="js-autopdflink" href="https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-05376.pdf" target="_blank" rel="noopener">notice</a> in the Federal Register on March 6, 2015, announcing the docket. The docket shall remain open until further notice.

FDA Establishes Docket for Public Comments on Drug Compounding