FDA Approved
8
Prescription access available
Investigational
5
Active clinical trials
Research Only
33
Not approved for human use
At-Risk / Crackdown
6
Active FDA enforcement
Regulatory Alerts
FDA Compounding Crackdown on GLP-1 Agonists
FDA removing compounded semaglutide and tirzepatide from shortage list. 503A pharmacies ordered to cease compounding. Multiple legal challenges pending.
Updated: 2026-03-15
Semaglutide Shortage Status Update
Novo Nordisk reports improved supply for Ozempic/Wegovy. FDA shortage resolution impacts compounding pharmacy availability. Transition periods being enforced.
Updated: 2026-02-28
FDA Warning Letters: Research Peptide Vendors
FDA issued warning letters to multiple vendors marketing BPC-157, TB-500, and other unapproved peptides for human use. Increased enforcement expected.
Updated: 2026-02-10
Retatrutide Phase 3 Results Expected
Eli Lilly's triple agonist retatrutide nearing Phase 3 completion. Potential FDA submission anticipated. May reshape GLP-1 market landscape.
Updated: 2026-01-20
Australia TGA Reclassification of Peptides
TGA reviewing Schedule 4 classification for several research peptides. Potential impact on availability for Australian researchers and clinicians.
Updated: 2026-01-08
Regulatory Timeline
Mar 2026 — FDA orders 503A pharmacies to stop compounding semaglutide2026-03-15
Feb 2026 — Semaglutide shortage status officially resolved by FDA2026-02-28
Feb 2026 — FDA issues warning letters to 12 peptide vendors2026-02-10
Jan 2026 — Retatrutide Phase 3 data readout expected2026-01-20
Jan 2026 — Australia TGA begins peptide reclassification review2026-01-08
Nov 2025 — Survodutide Phase 3 positive results announced (Boehringer)2025-11-12
Sep 2025 — Orforglipron oral GLP-1 Phase 3 enrollment completed2025-09-05
May 2025 — CagriSema (semaglutide+cagrilintide) NDA submitted2025-05-18
Mar 2025 — FDA crackdown on Melanotan II distribution2025-03-22
Dec 2024 — Tirzepatide approved for additional obesity indications2024-12-10
All
FDA Approved
Investigational
Research Only
Restricted
All Categories
GLP-1 / Metabolic
Growth Hormone
Repair / Recovery
Neuropeptides
Immune / Antimicrobial
Cosmetic / Anti-Aging
Hormonal
Other
Compound Registry
Country Availability Matrix
| Compound | FDA Status | US | UK | EU | CA | AU |
|---|
Frequently Asked Questions
Are peptides legal to buy in the United States?▼
It depends on the specific peptide. FDA-approved peptides like semaglutide and tirzepatide are legal with a valid prescription from a licensed provider. Research peptides such as BPC-157 and TB-500 can be purchased for laboratory research purposes but are not approved for human use by the FDA. The FDA has been increasing enforcement actions against companies marketing unapproved peptides for human consumption. Individual state laws may also apply.
What is the difference between 503A and 503B compounding pharmacies?▼
Section 503A pharmacies compound medications based on individual patient prescriptions from a licensed healthcare provider. They operate under state pharmacy board oversight. Section 503B outsourcing facilities can produce larger batches without individual prescriptions but must register with the FDA and comply with current Good Manufacturing Practice (cGMP) standards. The FDA has been scrutinizing both pathways for peptide compounding, particularly for GLP-1 receptor agonists during shortage periods.
Can I legally import peptides from overseas?▼
Importing prescription drugs or unapproved substances into the United States is generally prohibited under FDA regulations (21 USC 331). The FDA's personal importation policy allows limited exceptions but is not a legal right. Some countries like the UK and Australia have different regulatory frameworks. Enforcement varies by country and compound classification. Always verify current regulations in both the exporting and importing jurisdictions before attempting any import.
Will the FDA ban compounded semaglutide and tirzepatide?▼
The FDA has been actively working to restrict compounded versions of semaglutide and tirzepatide as brand-name drug shortages resolve. When a drug is removed from the FDA drug shortage list, 503A pharmacies generally must stop compounding copies of that drug. 503B outsourcing facilities may have additional transition periods. Multiple legal challenges from compounding pharmacies and trade associations are pending in federal courts. The situation is fluid and evolving rapidly.