Regulatory Compliance
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.
Last updated: February 13, 2026
Important Disclaimer: This information is provided for educational purposes only and does not constitute legal or regulatory advice. FDA regulations change frequently. Always verify current status directly with FDA sources and consult with legal counsel for compliance decisions. Compounding regulations may also vary by state.
FDA High-Risk Peptides
Includes Category 2 and other FDA safety-risk listings; verify current compounding status
| Peptide | FDA Status | 503A | 503B | Effective Date | Notes |
|---|---|---|---|---|---|
| BPC-157 | Category 2 | Prohibited | Prohibited | Sept 2023 | FDA cited insufficient safety data for human use |
| AOD-9604 | Removed from Cat 2 | Evaluate | Evaluate | Sept 2024 | Removed from Category 2; may be eligible for compounding |
| Selank | Safety-risk list | Check FDA | Check FDA | Jul 2025 | Listed by FDA as a substance that may present significant safety risks; verify current compounding status |
| Semax | Category 2 | Prohibited | Prohibited | Sept 2023 | Insufficient safety evidence |
| Epithalon | Category 2 | Prohibited | Prohibited | Sept 2023 | Lacks adequate safety and efficacy data |
| Dihexa | Category 2 | Prohibited | Prohibited | Sept 2023 | No human safety data available |
Drug Shortage Status
Compounding eligibility during shortages
| Drug | Shortage Status | 503A Allowed | 503B Allowed | Notes |
|---|---|---|---|---|
| Semaglutide | Shortage Resolved | Check FDA | Check FDA | Novo Nordisk supply restored; compounding eligibility changing |
| Tirzepatide | Shortage Resolved | Check FDA | Check FDA | FDA announced shortage resolution in Dec 2024; monitor FDA list for updates and policy changes |
| Dulaglutide | Currently Available | Check FDA | Check FDA | Not currently on FDA shortage list |
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, compounding eligibility typically ends. Always check the FDA Drug Shortage Database for the most current status before prescribing compounded versions.
503A vs 503B Compounding Explained
A
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
B
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
Frequently Asked Questions
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