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
FDA advisory meeting: July 23–24, 2026 — the PCAC reviews nominations for the Category 1 list.
In April 2026, the FDA removed 12 peptides from Category 2 — they are no longer designated a significant safety risk. Removal does not place them on the Category 1 (503A) list or authorize compounding; they sit in a regulatory gray zone pending review. Below are 6of the most in-demand peptides we’re tracking through that process — nothing is confirmed Category 1 yet (the FDA’s official 503A bulk-substances list has not been finalized).
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
Insufficient data. FDA has not received enough information to evaluate the substance for compounding.
In April 2026 the FDA removed the peptides listed below from Category 2; removal does not place them on the Category 1 (503A) list or authorize compounding. Once the FDA finalizes a substance on the Category 1 (503A) list, compounding pharmacies can legally produce it after meeting manufacturing and testing requirements. Until the official list publishes, treat each status as under review, not confirmed — and verify with the FDA or your pharmacist.
Under FDA review in the 2026 compounding process — not yet authorized, pending the FDA’s official Category 1 list.
Healing / Recovery
Skin / Copper Peptide
This page tracks publicly reported regulatory status — it is not legal or medical advice, and statuses can change. Verify current status with the FDA or a licensed pharmacist before acting.
We’ll email you the moment any Category 1 peptide becomes available from a verified compounding pharmacy. No spam. Unsubscribe anytime.
If added to the Category 1 list, these peptides could only be dispensed with a valid prescription from a licensed provider. Find an NPI-verified prescriber who works with compounded peptides — many offer telehealth nationwide.
In April 2026 the FDA removed 12 peptides from Category 2 (the significant-safety-risk list). Removal does not place them on the Category 1 (503A) list or authorize compounding — they sit in a regulatory gray zone. The peptides commonly discussed in this 2026 review include: BPC-157, GHK-Cu, Thymosin Beta-4 (TB-500), DSIP, Selank, GHK. None are confirmed Category 1 yet — the FDA's official 503A Bulk Drug Substances List has not been finalized. The FDA's Pharmacy Compounding Advisory Committee meets July 23–24, 2026 to review nominations and make recommendations.
Category 1 is the FDA list of bulk drug substances that may be used in 503A/503B compounding (with a valid prescription) while under review. Category 2 substances carry a significant safety risk and may not be compounded; Category 3 means the FDA lacks sufficient data to evaluate. As of April 2026, 12 peptides were removed from Category 2 — but removal does not authorize compounding, and none are confirmed on the finalized Category 1 list yet; the advisory PCAC meets July 2026 to review nominations and make recommendations to the FDA.
The FDA's Pharmacy Compounding Advisory Committee (PCAC) is an advisory committee that meets July 23–24, 2026 to review nominations for the 503A Bulk Drug Substances List — the list of bulk substances eligible for compounding by registered 503A pharmacies. The committee makes recommendations; the FDA issues any final rule later. The meeting is open to the public via the FDA's advisory committee calendar.
Disclosed Labs has indexed thousands of publicly available Certificates of Analysis for research peptides including BPC-157, TB-500, and other peptides in the Category 1 reclassification. Browse the full COA corpus at https://www.disclosedlabs.com/coas or view per-peptide testing summaries and current verified pricing on individual peptide pages.
Pharmacies prepare manufacturing
If peptides are added to the Category 1 list, 503A and 503B pharmacies could set up production — 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.
Healing / Recovery
Sleep / Neuropeptide
Anxiolytic / Nootropic
Skin / Wound Healing
Yes. If these peptides — including BPC-157, TB-500, MOTS-c, DSIP, and the others listed below — are added to the Category 1 list, they would require a valid prescription from a licensed provider under 503A and 503B compounding regulations. None are confirmed on the official Category 1 list yet; once the FDA finalizes it, compounding pharmacies could produce and dispense listed peptides to patients who have a prescription. Disclosed Labs maintains an NPI-verified prescriber directory at https://www.disclosedlabs.com/prescribers, including providers who offer telehealth consultations and work with compounded peptides.
Disclosed Labs