Tampa firm bets on unapproved peptides: DataMEDS moves into gray market

DataMEDS AI, a Nasdaq-listed healthcare company based in Tampa, has entered a supply agreement for six experimental peptides that lack FDA approval. The company will begin filling prescriptions this month through its subsidiary, Corexa Health. This move places the firm directly into a market where consumers have often purchased these compounds online under research-use-only labels.

The deal follows a policy change announced by the U.S. Department of Health and Human Services on Oct. 30. The new rules create a limited path for licensed pharmacies to compound specific peptides while the FDA continues its review process. The six substances involved, BPC-157, TB-500, KPV, MOTS-c, Epitalon, and Semax, have not yet been evaluated by the FDA for safety or effectiveness.

Gerald Commissiong, the company's interim co-CEO, stated that many patients currently buying from the gray market would prefer to purchase from a licensed pharmacy. The plan is to bring these customers into conventional prescription channels. In this model, physicians prescribe compounded preparations and pharmacists dispense them under federal and state requirements.

DataMEDS will manage the distribution through a warehouse in Lakeland, Florida. The company will handle supplies from manufacturers and make the ingredients available to qualifying compounding pharmacies. It will use its existing third-party logistics business for this operation. The network includes more than 6,500 independent pharmacies, though the announcement did not specify how many will participate.

The FDA's Pharmacy Compounding Advisory Committee considered these six substances during meetings on July 23 and 24. The committee examined proposed uses for wound healing, inflammation, obesity, insomnia, and neurological disorders. These applications remain unproven. The HHS enforcement policy does not grant official FDA approval.

Participating pharmacies must meet specific requirements for ingredient sourcing, testing, and labeling. They must also report adverse events and product-quality problems. Federal officials retain the ability to change or withdraw the policy at any time. DataMEDS plans to use its Health Lives Here mobile application to collect and report safety information under the new rules.

The company has not disclosed the financial terms of the supply agreement, the identity of the supplier, or the expected revenue. The rollout will run through Corexa Pharmacy, which is part of a larger healthcare operation that includes pharmaceutical distribution, technology platforms, and a clinical diagnostics laboratory in Pittsburgh.