HHS Announces Interim Enforcement Discretion for Six Peptides
The U.S. Department of Health and Human Services (HHS) has announced an interim enforcement-discretion policy on certain compounded peptides while the U.S. Food and Drug Administration (FDA) considers whether the substances should ultimately be permitted for compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act. This policy was only recently announced as being sent to the White House for review and it now appears to be in effect.
Under the policy, which can be read in PDF form here, HHS states that it does not intend to take enforcement action against 503A compounding pharmacies such as state-licensed pharmacies, federal facilities or licensed physicians for compounding products using six specified peptide bulk drug substances: BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500, provided that detailed safeguards and other applicable Section 503A requirements are satisfied.
Those safeguards include sourcing the peptide from an FDA-registered manufacturer that complies with CGMP requirements; obtaining appropriate certificates of analysis addressing identity, purity, potency and contaminants; reporting serious adverse events and product-quality issues; using only a single listed active ingredient in the compounded product; meeting specified labeling and delivery-device requirements; and compounding pursuant to a valid patient-specific prescription.
Importantly, the policy does not mean these peptides are FDA-approved or that FDA has formally added them to the 503A Bulks List. Rather, it establishes a period of temporary enforcement discretion while FDA conducts rulemaking regarding their status. HHS also reserves the ability to revisit the policy if safety signals or product-quality concerns emerge.
What This Means for Medical Spas
Practices should not interpret the announcement as a blanket authorization to prescribe, dispense or administer these peptides. Compounders must satisfy all of the policy’s specific conditions, and prescribers and medical spas must continue to comply with applicable federal and state prescribing, compounding, scope-of-practice and pharmacy requirements. But this new policy eases one of the main barriers to employing these treatments.
This is a rapidly evolving area, and the details or status of these peptides may continue to evolve. We will continue to follow this story. Become an AmSpa Member to keep up with must-know med spa regulations.
