FDA Regulatory Quick Reference
Navigate FDA regulations on peptide compounding with confidence. This reference guide helps prescribers stay compliant with current Category 2 designations, drug shortage status, and 503A/503B compounding requirements.
What PCAC recommended — and what FDA has done
On July 23–24, 2026, PCAC voted to recommend adding six peptides to the 503A bulks list and voted against DSIP. FDA has not added these seven peptides to the final list.
The votes cover the free base and acetate forms. A committee recommendation does not authorize compounding or approve a drug. Vote counts below are reported by McDermott Will & Schulte; the FDA meeting record and current final list are linked under Sources.
| Peptide | July 2026 PCAC vote | FDA final 503A list | What this means |
|---|---|---|---|
| BPC-157 | PCAC voted to add 8 for, 6 against, 1 abstention | Not on final list | PCAC recommended adding the free base and acetate forms. FDA has not added them to the final 503A bulks list. |
| KPV | PCAC voted to add 8 for, 6 against, 1 abstention | Not on final list | PCAC recommended adding the free base and acetate forms. FDA has not added them to the final 503A bulks list. |
| TB-500 | PCAC voted to add 8 for, 6 against, 1 abstention | Not on final list | PCAC recommended adding the free base and acetate forms. FDA has not added them to the final 503A bulks list. Verify the exact substance; TB-500 is not interchangeable with full-length thymosin beta-4. |
| MOTS-c | PCAC voted to add 7 for, 5 against, 2 abstentions | Not on final list | PCAC recommended adding the free base and acetate forms. FDA has not added them to the final 503A bulks list. |
| Semax | PCAC voted to add 8 for, 5 against, 1 abstention | Not on final list | PCAC recommended adding the free base and acetate forms. FDA has not added them to the final 503A bulks list. |
| Epitalon (Epithalon) | PCAC voted to add 7 for, 4 against, 1 abstention | Not on final list | PCAC recommended adding the free base and acetate forms. FDA has not added them to the final 503A bulks list. |
| Emideltide (DSIP) | PCAC voted against 6 for, 7 against, 1 abstention | Not on final list | PCAC recommended against adding the free base and acetate forms. Neither is on the final 503A bulks list. |
| Dihexa | No July PCAC vote Not reviewed at the July 23–24 meeting | Not on final list | The July committee did not vote on Dihexa. FDA continues to publish safety concerns about dihexa acetate. |
| Cathelicidin LL-37 | No July PCAC vote Not reviewed at the July 23–24 meeting | Not on final list | The July committee did not vote on LL-37. FDA continues to publish safety concerns about it. |
| GHK-Cu (injectable) | No July PCAC vote Not reviewed at the July 23–24 meeting | Not on final list | The July committee did not vote on injectable GHK-Cu. Non-injectable GHK-Cu is in Category 1; that status does not cover injectable routes. |
| Melanotan II | No July PCAC vote Not reviewed at the July 23–24 meeting | Not on final list | The July committee did not vote on Melanotan II. FDA continues to publish safety concerns about it. |
Drug Shortage Status
Published shortage determinations and compounding considerations. Check the live FDA database before relying on a status.
| Drug | Shortage Status | 503A Status | 503B Status | Notes |
|---|---|---|---|---|
| Semaglutide | Shortage Resolved | Check FDA | Check FDA | FDA resolved the semaglutide injection shortage on February 21, 2025. Shortage-related enforcement discretion ended in 2025; current 503A and 503B requirements still apply. |
| Tirzepatide | Shortage Resolved | Check FDA | Check FDA | FDA reaffirmed resolution of the tirzepatide injection shortage on December 19, 2024. Shortage-related enforcement discretion ended in 2025; current 503A and 503B requirements still apply. |
| Dulaglutide | Check FDA | Check FDA | Check FDA | Verify the current FDA shortage record. Manufacturer-reported availability does not itself mean FDA has resolved a shortage. |
Note on drug shortages: When a drug is on the FDA shortage list, 503A and 503B pharmacies may have expanded ability to compound that medication. When a shortage is resolved, shortage-based exceptions and enforcement discretion may end; other statutory conditions still apply. Always check the FDA Drug Shortage Database for the most current status before prescribing compounded versions.
Data governance: Sources checked October 3, 2026. Next review target October 10, 2026.
Interpretation note: Removal from Category 2 and a PCAC recommendation do not establish inclusion on the final 503A bulks list or FDA approval. The peptides above are not listed in 21 CFR 216.23 as checked on the review date. The 503A and 503B requirements must be evaluated separately.
Sources: Reported PCAC vote results — McDermott Will & Schulte, FDA 503A nomination categories (May 14, 2026), FDA safety information for withdrawn nominations, July 23–24, 2026 PCAC meeting materials, Current 503A bulks list — 21 CFR 216.23, FDA 503A bulk substance requirements and interim policy, FDA GLP-1 compounding policy, FDA Drug Shortage Database
April 2026 background
What the April 2026 503A category changes mean
The clinician version of the April 15, 2026 FDA update, including what changed and what still requires caution.
Quick reference
Peptides removed from category 2
Background on the April 2026 withdrawal notices. Use the table above and current FDA sources for the latest status.
FDA meeting record
PCAC recommended six peptides; FDA has not added them
BPC-157, KPV, TB-500, MOTS-c, Semax, and Epitalon received favorable recommendations. DSIP did not. Read the FDA meeting materials.
503A vs 503B Compounding Explained
503A Pharmacy
Traditional compounding pharmacy operating under state board of pharmacy oversight.
- •Patient-specific: Requires a valid prescription for an identified patient
- •No office stock: Cannot prepare medications in advance without a prescription
- •State regulated: Licensed by state board of pharmacy; requirements vary by state
- •Best for: Individual patient prescriptions, customized formulations
503B Outsourcing Facility
FDA-registered outsourcing facility operating under cGMP standards with federal oversight.
- •Office stock allowed: Can produce medications without a patient-specific prescription
- •Larger batches: Can compound larger quantities for healthcare facilities
- •FDA regulated: Subject to FDA inspection and current Good Manufacturing Practice (cGMP)
- •Best for: Clinics needing office stock, standardized preparations
For supplier evaluation, COA review, and patient counseling on the “Research Use Only” label, see the sourcing guide.
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