March 4, 2024

Statement on Law and Regulation Governing Peptide Compounding

The APC Board of Directors has authorized release of a public statement, Understanding Law and Regulation Governing the Compounding of Peptide Products.

The purpose of the statement is to educate pharmacy compounders and prescribers on federal law and FDA guidance on peptides, especially in light of FDA’s September 2023 addition of several peptides to Category 2 of its 503A Interim Bulks Guidance. The statement also describes the proper pathway for renominating substances for reconsideration by the agency. 

Please review the statement carefully and share it with your colleagues and the prescribers you work with. An updated APC Prescriber Brief on compounding of peptide products will also be made available later this week and will be posted with APC’s other Prescriber Briefs.

“We don’t have to agree with FDA’s actions on peptides — and on plenty of other things as well,” said APC Board Chair Joseph P. Navarra, RPh, FACA, FAPC. “But we do have to adhere to laws and regulations. It’s a duty we owe our patients … and the credibility of our profession.”