On October 28, 2026, FDA issued a landmark 'enforcement discretion policy' temporarily permitting 503A compounding pharmacies to compound and dispense six peptides pursuant to a patient prescription. The six peptides: BPC-157, TB-500, Epitalon, KPV, MOTS-C and Semax were supported in July 2026 by the Pharmacy Compounding Advisory Committee (PCAC). These six peptides are currently undergoing the lengthy Notice and Comment Rulemaking process to add them to the 503A Bulk List. FDA's enforcement discretion policy is clearly an attempt to thwart the 'research use only' ('RUO') online grey area for direct to consumer sales of peptides. FDA's action greenlights sale by wholesalers, advertising (pursuant to the existing very restrictive advertising limits for compounds), compounding by 503A, physicians and Federal facilities (but not 503B outsourcing facilities).

The peptides must still be sourced from an FDA-registered manufacturer (not on the Red List), must be pharmaceutical (not RUO) grade, and be accompanied by a valid Certificate of Analysis. Robust patient informed consent, waivers, and clinical record documentation are warranted. Indemnification, recall, adverse event reporting, quality issue handling take even greater importance in contracts between parties, whether it be telehealth platforms, central fill agreements as these peptides remain FDA unapproved and without USP monographs.

This move by FDA conflicts with the growing number of State Boards of Pharmacy (and Medicine) who issued aggressive warnings to compounders and physicians backed up by recent enforcement efforts. Boards of Pharmacy took a restrictive stance even after the July 2026 FDA PCAC decision. It remains to be seen whether the Boards will ease up on these efforts in view of FDA's enforcement discretion policy.

FDA's decision, signed and spearheaded by HHS Secretary Robert F. Kennedy, Jr., keeps his 2024 promise to the public to increase availability of peptides.

How Health Law Alliance Can Help

Health Law Alliance can help you navigate state rules and the federal regulatory framework governing peptides to proactively mitigate exposure. Our legal team works with pharmacists, prescribers, telehealth companies, and wholesalers to analyze state-specific restrictions, including advertising, vetting pharmaceutical grade sourcing, prescribing, delegation models, patient consent and waivers, documentation, and protocols to support your goals. Confirm current requirements with counsel before marketing, sourcing, prescribing or compounding peptides to ensure solid legal standing. If your practice has already received an FDA Warning, subpoena, or state board inquiry, contact counsel before taking action.