Patient access to compounded peptides has taken an important step forward. HHS has announced a draft enforcement discretion policy for certain peptide bulk drug substances used in 503A compounding, following the FDA Pharmacy Compounding Advisory Committee’s vote in July to recommend six peptides for the 503A bulks list: BPC-157, TB-500, KPV, MOTS-c, Epitalon, and Semax. We’ve been anticipating this moment since the committee’s review, and we’re encouraged by the draft policy’s potential to help more patients access personalized care through licensed healthcare providers and regulated pathways.
Demand for peptides hasn’t waited for policy, and too many people have turned to unregulated sources to find them. This interim pathway offers a more controlled route through licensed pharmacies and patient-specific prescriptions. For patients, this means a prescription, a provider, and a quality system are behind every product.
What Comes Next
With this policy now providing a clearer path forward, Empower is preparing eligible products for first availability, which we expect around mid-November based on the FDA’s indicated timeline. All products will be dispensed consistent with applicable requirements and prescriptions from licensed healthcare providers.
Every prescribed peptide Empower compounds moves through the same quality system behind everything we make. These controls help us verify what we make and support accountability for every batch. Our focus remains on quality and on supporting individualized patient care through responsible compounding.
We appreciate HHS’ consideration of patient access and the continued work of regulators, healthcare providers, and the broader healthcare community.
Empower is ready to move forward, and we remain committed to the high standards of quality our patients and providers count on as the regulatory process continues.
