Olympia Pharmaceuticals to Compound Select Peptides Under HHS Interim Enforcement Policy
503A pharmacy will begin compounding BPC-157, with plans to expand across eligible peptides
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ORLANDO, Fla., Nov. 12, 2026 (GLOBE NEWSWIRE) — Olympia Pharmaceuticals, a premier FDA-registered 503B outsourcing facility and 503A pharmacy, today announced that its 503A pharmacy will begin compounding select peptides following the U.S. Department of Health and Human Services’ (HHS) issuance of its Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances. Under the conditions outlined in the policy, Olympia plans to initially launch compounding for BPC-157 for patients with a valid prescription. The 503A pharmacy plans to evaluate and roll out additional authorized peptides, including KPV, TB-500, MOTS-c, semax, and epitalon.
According to the HHS, the interim policy is intended to discourage the use of research-use-only peptides supplied by foreign manufacturers and to give patients a more controlled alternative while the FDA reviews these substances. The policy applies until each peptide is addressed in a final rule, and HHS may revisit it if safety or quality concerns arise.
“Patients who want these peptides should be getting them from a pharmacy with a prescription, and our state-regulated pharmacy will soon be ready to compound them,” said Joshua Fritzler, president of Olympia Pharmaceuticals. “Given the significant patient demand for these therapies, expanding this pathway to also include 503B outsourcing facilities is the natural next step. The large-scale manufacturing capacity and cGMP standards of 503B facilities are what will ultimately allow the industry to meet demand and move patients away from unverified research-use-only channels.”
To qualify under the HHS policy, compounded formulations must contain only a single active ingredient, must be dispensed pursuant to a patient-specific prescription, and must be labeled as compounded drug products not for resale. The policy also limits each peptide to specific authorized routes of administration and dosage forms, and mandates the use of FDA 510(k)-cleared delivery devices.
“This policy is an important step toward redirecting patients away from the gray market and toward pharmacies that are accountable for what they dispense,” said David Flynn, senior director of legal and regulatory affairs at Olympia Pharmaceuticals. “It establishes strict requirements for verified sourcing from FDA-registered manufacturers, rigorous ingredient testing, and direct adverse-event reporting to FDA MedWatch. Olympia will compound in strict accordance with each condition outlined by HHS and will adapt as federal and state regulatory guidance evolves.”
Olympia holds active licenses in 49 states and plans to make the peptides covered by the policy available to patients by December. For more information about Olympia Pharmaceuticals, visit olympiapharmacy.com.
About Olympia Pharmaceuticals
Olympia Pharmaceuticals is a state-of-the-art, FDA-registered 503B pharmaceutical outsourcing facility and 503A pharmacy supporting both patient-specific and office-use needs across the U.S. Co-founded by Stan and Naomi Loomis, the team is made up of pharmacy technicians, pharmacists, quality personnel, and engineers, creating an educated and experienced staff knowledgeable in all facets of pharmacy production. As an FDA-registered outsourcing facility, Olympia offers compounded medications to 49 states for both office use and patient prescriptions. Olympia specializes in weight loss, dermatology, IV nutritional therapy, erectile dysfunction, and more.
Media Contact
Daniele Spring
Uproar by Moburst for Olympia Pharmaceuticals
daniele.spring@moburst.com
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