BREAKING NEWS
APRIL 15, 2026 - In a welcome announcement to the SSRP community, the FDA reported today that it will imminently remove the following bulk drug substances from category 2: BPC-157, LL-37, DiHexa, DSIP, Epitalon, *GHK-Cu (injectable only), KPV, PEG-MGF, Melanotan II, MOTs-C, Semax, and TB-500. Originally nominated for Category 2 (Bulk Substances that Raise Significant Safety Concerns), the withdrawal of these nominations would indicate that the FDA is reconsidering the validity of respective safety concerns. Removal from Category 2 also lessens restrictions on US compounding pharmacies ability to produce these peptides. The FDA announcement also suggests that its July 2026 meeting will, in short order, explore giving these peptides full approval. *Non-injectibile GHK-Cu has also been singled out for further consideration by February 2027.
William Seeds, MD, Founder of the SSRP Institute and recognized globally as the pioneer and leading authority on peptide therapy, points out, “this is not just exciting news; it’s also a testament to the power of what we know are effective agents that have been shown to accelerate healing, protect immunity, and restore cellular function when applied under the care of a trained provider. It’s about time.”
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Click here to read the FDA announcement. For future updates like this, education, training, and support, explore what the SSRP community has to offer.