Informational only. Not medical advice.INFORMATIONAL PLATFORM ONLY — NOT MEDICAL ADVICE, DIAGNOSIS, OR TREATMENT
Informational only. Not medical advice.INFORMATIONAL PLATFORM ONLY — NOT MEDICAL ADVICE, DIAGNOSIS, OR TREATMENT
Regulatory changes are active now. Get notified before these peptides hit the market.
The FDA has reclassified 14 peptides as Category 1, meaning they are eligible to return to legal compounding by registered 503A and 503B pharmacies. This is the biggest regulatory shift in the peptide industry in over a decade.
The FDA categorizes bulk drug substances (BDS) into three categories for compounding eligibility:
Category 1
Eligible for compounding. FDA has determined these substances can be safely compounded under current regulations.
Category 2
Under review. FDA is evaluating whether these substances should be permitted for compounding.
Category 3
Not eligible. FDA has determined these substances should not be compounded due to safety concerns.
The 14 peptides listed below were recently reclassified from Category 2 to Category 1, meaning compounding pharmacies can legally produce them once they meet manufacturing and testing requirements.
All reclassified to Category 1 — eligible for legal compounding.
Healing / Recovery
Skin / Copper Peptide
Growth Hormone Secretagogue
Growth Hormone Secretagogue
Immune Modulation
Healing / Recovery
Growth Hormone Releasing
Anti-Aging / Telomere
Sleep / Neuropeptide
Anxiolytic / Nootropic
Nootropic / Cognitive
Metabolic / Fat Loss
Hair Growth
Skin / Wound Healing
We’ll email you the moment any Category 1 peptide becomes available from a verified compounding pharmacy. No spam. Unsubscribe anytime.
Pharmacies prepare manufacturing
503A and 503B pharmacies are now setting up production for Category 1 peptides, including sourcing active ingredients and establishing quality testing protocols.
Quality testing begins
Each batch must pass identity, purity, potency, endotoxin, and sterility testing before it can be dispensed.
Prescribers start ordering
Once available, prescribers can order compounded versions of these peptides for their patients through verified pharmacies.
We verify and list
Disclosed Labs will independently test early batches from compounding pharmacies and publish results for transparency.
Regulatory information is for informational purposes only. Not medical or legal advice. Consult qualified professionals for guidance.
Disclosed Labs