What are Category 2 peptides?

Category 2 is an FDA classification for bulk drug substances that raise significant safety concerns for compounding. In April 2026, FDA also issued notice that several peptide-related substances will be removed from category 2 after a seven-day notice period, so clinicians should use exact dates and official FDA source documents instead of relying on older summaries.

What is the difference between 503A and 503B compounding?

503A pharmacies are traditional compounding pharmacies that prepare patient-specific prescriptions under state regulation. 503B outsourcing facilities are FDA-regulated, operate under cGMP standards, and can prepare larger batches for office stock without patient-specific prescriptions. 503B facilities undergo FDA inspection and must report adverse events.

Can I still prescribe BPC-157?

As of April 19, 2026, FDA has issued notice that BPC-157 will be removed from category 2 after seven calendar days because the nomination was withdrawn, and FDA has also announced a July 23, 2026 PCAC discussion on potential inclusion of related bulk drug substances on the 503A bulks list. That removal notice is not the same thing as final FDA approval or final inclusion on the bulks list, so prescribers should verify the current posture directly from FDA materials.

How do drug shortages affect peptide compounding?

When an FDA-approved drug is in shortage, pharmacies may be permitted to compound versions of that drug under certain conditions. This has been relevant for GLP-1 agonists like semaglutide and tirzepatide. The FDA maintains a Drug Shortage Database that prescribers should monitor for current status updates.

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: April 19, 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 safety-risk entries plus April 2026 removal notices; verify current compounding status.

Peptide	FDA Status	503A	503B	Effective Date	Notes
BPC-157	Removal notice	Check FDA	Check FDA	Apr 22, 2026	FDA issued notice that BPC-157 will be removed from category 2 after seven calendar days because the nomination was withdrawn. FDA also announced a July 23, 2026 PCAC discussion on potential inclusion on the 503A bulks list.
Semax	Removal notice	Check FDA	Check FDA	Apr 22, 2026	FDA issued notice that Semax-related bulk drug substances will be removed from category 2 after seven calendar days. FDA announced a July 24, 2026 PCAC discussion on potential inclusion on the 503A bulks list.
Epithalon (Epitalon)	Removal notice	Check FDA	Check FDA	Apr 22, 2026	FDA issued notice that Epitalon-related bulk drug substances will be removed from category 2 after seven calendar days. FDA announced a July 24, 2026 PCAC discussion on potential inclusion on the 503A bulks list.
Dihexa	Removal notice	Check FDA	Check FDA	Apr 22, 2026	FDA issued notice that Dihexa acetate will be removed from category 2 after seven calendar days. This does not itself equal final inclusion on the 503A bulks list.
Cathelicidin LL-37	Removal notice	Check FDA	Check FDA	Apr 22, 2026	FDA issued notice that Cathelicidin LL-37 will be removed from category 2 after seven calendar days. FDA also announced a future PCAC consultation before the end of February 2027.
GHK-Cu (injectable)	Removal notice	Check FDA	Check FDA	Apr 22, 2026	FDA issued notice that injectable GHK-Cu will be removed from category 2 after seven calendar days. FDA also announced a future PCAC consultation before the end of February 2027.
KPV	Removal notice	Check FDA	Check FDA	Apr 22, 2026	FDA issued notice that KPV will be removed from category 2 after seven calendar days. FDA announced a July 23, 2026 PCAC discussion on potential inclusion on the 503A bulks list.
Melanotan II	Removal notice	Check FDA	Check FDA	Apr 22, 2026	FDA issued notice that Melanotan II will be removed from category 2 after seven calendar days. FDA also announced a future PCAC consultation before the end of February 2027.
MOTS-c	Removal notice	Check FDA	Check FDA	Apr 22, 2026	FDA issued notice that MOTS-c will be removed from category 2 after seven calendar days. FDA announced a July 23, 2026 PCAC discussion on potential inclusion on the 503A bulks list.
TB-500 (LKKTETQ fragment)	Removal notice	Check FDA	Check FDA	Apr 22, 2026	FDA issued notice that TB-500-related bulk drug substances will be removed from category 2 after seven calendar days. FDA announced a July 23, 2026 PCAC discussion on potential inclusion on the 503A bulks list.

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.

Data governance: Last reviewed April 19, 2026. Next scheduled review July 23, 2026.

Interpretation note: A removal notice from category 2 is not the same thing as final inclusion on the 503A bulks list or blanket authorization to compound. Use the linked FDA and Federal Register materials for the exact current posture.

Primary sources: Source 1, Source 2, Source 3

New update

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

A dated list of the peptide-related substances FDA said will be removed from category 2 after the April 2026 notice period.

Meeting preview

What to watch before the July 2026 PCAC meeting

Use the agenda and timing to prepare internal scripts, patient explanations, and staff training before the next FDA milestone.

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.

Read the Sourcing Guide

Official FDA Resources

FDA Bulk Drug Substances ListCategory 1, 2, & 3 lists

FDA Drug Shortage DatabaseCurrent shortage status

503A/503B GuidanceCompounding regulations

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FDA Regulatory Quick Reference

FDA High-Risk Peptides

BPC-157

Semax

Epithalon (Epitalon)

Dihexa

Cathelicidin LL-37

GHK-Cu (injectable)

KPV

Melanotan II

MOTS-c

TB-500 (LKKTETQ fragment)