Oct 28 (Reuters) – The US health department will temporarily allow pharmacies and physicians to compound certain peptide ingredients, while regulators decide whether the substances should be formally permitted for use in compounded medicines.
The interim policy covers six peptides including popular tissue-repair compound BPC-157, epitalon used for insomnia, KPV for wound healing and inflammatory conditions, MOTS-c for obesity and osteoporosis, Semax for migraines and chronic pain, and TB-500.
BPC-157 is often taken together with a second peptide, TB-500, in a combination popularly known as the “Wolverine stack.”
An FDA advisory committee earlier recommended that the agency consider allowing all six for use in compounding, but the recommendations did not themselves authorize their use.
The Department of Health and Human Services said it would not take enforcement action against compounders using certain peptide ingredients if they meet requirements on ingredient quality, manufacturing standards, safety reporting, labeling and patient-specific prescriptions.
This policy will discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers that pose a safety risk to US patients, and improve patient access, it said.
HHS said it may reconsider the interim policy if safety signals or product-quality problems emerge. The policy does not constitute FDA approval of the peptides or the compounded medicines made from them.
Peptides, or short chains of amino acids, have boomed in popularity over the past year, driven by endorsements from wellness influencers, for uses ranging from anti-aging to muscle recovery and tissue repair.
Health Secretary Robert F. Kennedy Jr. has publicly supported broader access to peptides, calling himself a “big fan” of the treatments, and has said he has used them with “really good effect.”
Analysts estimate the peptide industry could quickly become a $2 billion to $3 billion market, if legitimized.
Telehealth companies such as Hims & Hers Health have been preparing to roll out peptide offerings once cleared by federal regulators.
(Reporting by Sneha S K and Kamal Choudhury in Bengaluru; Editing by Shilpi Majumdar and Maju Samuel)
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