Statement on the FDA and HHS enforcement discretion policy for 503a compounding with certain peptides

October 28, 2026 (Washington, D.C.) — Partnership for Safe Medicines Executive Director Shabbir Imber Safdar released the following statement regarding the Food and Drug Administration (FDA) and Department of Health and Human Services’ (HHS) Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances.

"Today's decision leaves Americans in a grey area as to whether peptides are safe or not, even though the FDA’s own scientists recommended against voting in favor of these substances due to concerns with evidence.

“The Administration’s decision comes after a vote from the FDA’s Pharmacy Compounding Advisory Committee in support of compounding six ‘wellness’ peptides. However, overlooked in this vote is that many newly appointed PCAC members appear to have conflicts of interest directly related to the peptide substances under consideration. This outcome shreds any sense of credibility and transparency, placing their interests above the safety of the American people.

“Last week, PSM filed a citizen petition urging the FDA to disregard the vote and block compounding of unapproved peptides. The petition argues that there is insufficient scientific evidence to support the safety of these peptide products and that the committee was constituted in violation of the Federal Advisory Committee Act (FACA) and the Ethics in Government Act (EIGA), federal laws that govern conflicts of interest in agency advisory proceedings.

“The Administration should change course and focus on prosecuting the bad actors who have been illegally producing and distributing dangerous products to the public.”