Telehealth giants and compounding pharmacies prepare for FDA peptide reclassification
As the US Food and Drug Administration prepares to discuss loosening rules on peptide production, industry players are investing heavily in testing and infrastructure, despite warnings from scientists and regulators about premature market entry.
The US Food and Drug Administration is scheduled to discuss the reclassification of a group of peptides on July 23 and 24, a move that could allow pharmacies to legally compound custom mixes. This potential regulatory shift would reverse a 2023 decision by the Biden Administration which barred certain peptides from compounding. The decision follows a surge in popularity for peptides, driven by social media influencers, political figures such as US Secretary of Health and Human Services Robert F. Kennedy Jr., and the broader GLP-1 market boom. While telehealth companies and compounding pharmacies are preparing for this change, career scientists at the FDA have recommended against reclassification due to safety concerns.
Telehealth platforms and compounding pharmacies are already positioning themselves for the anticipated regulatory change. Myra Ahmad, chief executive of Mochi Health, stated that partner pharmacies have completed safety testing and are finalising pricing. Hims & Hers Health purchased a peptide manufacturing facility in February 2025 and is developing clinical protocols; its chief medical officer, Anant Vinjamoori, is slated to testify at the FDA hearing. Olympia Pharmaceuticals has invested significant funds to create peptide formulas in anticipation of the change, with president Joshua Fritzler noting that the company is preparing for a significant industry shift.
Biotech firms are also seeing increased demand for validation services. Sapho Bio has been approached to test various peptides, including BPC-157 and MOTS-c, with some pharmacies investing approximately $100,000 into testing before full market release. Cameron Bravo, a research scientist at Sapho Bio, noted that the company runs tests to ensure mixtures are uncontaminated and properly sealed. The GLP-1 boom has normalised home injections and generated significant revenue for pharmacies and virtual clinics, creating a fertile ground for expansion into other peptide categories.
Despite industry optimism, the regulatory process involves significant hurdles. The FDA process involves a review period where proposed rules are subject to public comment, meaning immediate market entry is not guaranteed even if reclassification is approved. Vinjamoori indicated that Hims & Hers Health plans to wait and see rather than rush to market, stating the company aims to be best in market rather than first. However, some clinics are already moving ahead; Amanecia Health has begun tentatively prescribing BPC-157 to a small group of patients, acknowledging the lack of FDA-approved safety and efficacy data.
Industry groups have warned against premature market entry, noting pressure from prescribers and patients. Scott Brunner of the Alliance for Pharmacy Compounding has cautioned member pharmacies against going rogue, highlighting the risks of non-compliance. Meanwhile, a gray market for research-grade peptides remains active, with companies like OnTop Labs selling products such as Melanotan II. The Skin Cancer Foundation has warned that Melanotan II may increase melanoma risk, underscoring the safety concerns raised by career scientists at the FDA who have recommended against reclassifying these peptides.
