Final/effective
Semaglutide injection shortage resolved
FDA's February 2025 order ends the Ozempic and Wegovy shortage. Compounding transition windows are now closing.
Latest updates
View allEffective
WADA 2025 Prohibited List now in force
The updated list, effective January 1, 2025, keeps non-approved peptides such as BPC-157 in S0 and reminds athletes that sport rules differ from drug-approval rules.
Final/effective
Tirzepatide shortage resolved: what changed for compounders
FDA's December 2024 declaratory order ends the national shortage of Mounjaro and Zepbound. Here's what the status change does—and does not—mean.
Enforcement action recorded
FDA warning letter: retatrutide and sermorelin products are unapproved new drugs
The December 2024 Xcel Research warning letter shows how FDA treats 'research use only' labels when website claims indicate intended human use.
Final
FDA places BPC-157 in Category 2 significant safety risks
The September 2024 update to the 503A bulk list keeps BPC-157 off the lawful compounding list because of safety concerns.
Status at a glance
Every tracked peptide across the activities that matter — FDA approval, 503A/503B compounding, shortage, and sport rules. Hover any marker for the qualified detail.
| Substance | FDA | 503A | 503B | Shortage | WADA |
|---|---|---|---|---|---|
| BPC-157 | · | ||||
| Bremelanotide | · | · | · | · | |
| GHK-Cu | · | · | · | ||
| Ipamorelin | · | · | |||
| Melanotan II | · | · | · | ||
| Retatrutide | · | · | |||
| Semaglutide | · | · | |||
| Sermorelin | · | · | · | ||
| Tesamorelin | · | · | · | ||
| Tirzepatide | · | · |
Approved / component-approvedRestricted / route-dependentSafety risk / prohibitedShortage resolvedNot approved / not listed· No determination
Explore substances
Search by name or alias, filter by regulatory status, and select up to three to compare side-by-side.
BPC-157
Not an approved drugFDA503A503BWADA
Also: Body Protection Compound-157, Bepecin, PL-14736
A synthetic 15-amino-acid peptide. It has no USAN, no USP/NF monograph, and is not a component of an FDA-approved drug. Commercial products may be sold as BPC-157 acetate or BPC-157 free base, which are distinct active pharmaceutical ingredients.
Bremelanotide
Approved product — specific indication/routeFDA
Also: PT-141, Vyleesi
A melanocortin receptor agonist peptide. FDA approved it as Vyleesi for a specific premenopausal HSDD indication.
GHK-Cu
Not an approved drugFDA503A
Also: Copper peptide GHK-Cu, glycyl-L-histidyl-L-lysine copper
A tripeptide-copper complex. It is not a component of an FDA-approved drug. FDA's categorization differs by route of administration.
Ipamorelin
Not an approved drugFDA503A503B
Also: Ipamorelin acetate, NNC 26-0091
A synthetic pentapeptide growth hormone secretagogue. No USAN or USP/NF monograph; not a component of an FDA-approved drug.
Melanotan II
Not an approved drugFDA503A
Also: MT-II, Melanotan 2
A synthetic melanocortin peptide. It is not a component of an FDA-approved drug and has no USP/NF monograph.
Retatrutide
Not an approved drug / investigationalFDA503A
Also: LY3437943, RETA
A triple agonist of GIP, GLP-1, and glucagon receptors. It is an investigational drug and is not a component of any FDA-approved product.
Semaglutide
Approved product — specific indication/routeFDAShortage503A
Also: Ozempic, Rybelsus, Wegovy
A GLP-1 receptor agonist approved in three FDA-approved products with different routes, indications, and strengths.
Sermorelin
Approved product discontinued from marketingFDA503B
Also: Sermorelin acetate, Geref
A growth hormone-releasing hormone analog. Geref (sermorelin acetate) was FDA approved but is discontinued from marketing per Drugs@FDA. It remains a component of a previously approved drug.
Tesamorelin
Approved product — specific indication/routeFDA503B
Also: Egrifta, TH9507
A growth hormone-releasing factor analog. FDA has approved it in Egrifta for a specific HIV-associated indication.
Tirzepatide
Approved product — specific indication/routeFDAShortage503A
Also: LY3298176, Mounjaro, Zepbound
A dual GIP/GLP-1 receptor agonist peptide. FDA has approved it as the active ingredient in Mounjaro and Zepbound for specific indications, routes, strengths, and products.
Claim check
View allClaim check · U.S. federal · 2026-07-23
“The FDA advisory committee voted to approve the peptide.”
Think it through first — then check it against the controlling source.
Claim check · U.S. federal · 2025-02-21
“Compounded tirzepatide and semaglutide are still legal now that the shortages are over.”
Think it through first — then check it against the controlling source.
Claim check · U.S. federal · 2024-09-27
“BPC-157 is FDA approved / legal to use / a safe peptide.”
Think it through first — then check it against the controlling source.
Claim check · U.S. federal · 2024-12-10
“A product labeled 'research use only' or 'not for human use' is not an FDA-regulated drug.”
Think it through first — then check it against the controlling source.
Trackers
View allDrug-shortage tracker
National shortage status and effective dates for FDA-approved peptide products.
Enforcement tracker
Selected FDA warning letters and enforcement actions involving peptide products.
FDA peptide compounding tracker
Selected peptides on FDA's 503A and 503B bulk drug substance lists, with category and route restrictions.
What the Rulebook covers
- ✓ FDA approval, compounding, and shortage status for peptides
- ✓ Jurisdiction-specific rules and enforcement actions
- ✓ Source-linked updates with controlling documents
- ✓ Plain-language claim checks on common misconceptions
Methodology
Every status assertion is tied to a controlling source, reviewed by a qualified regulatory reviewer, and dated. We distinguish between an approved drug product, an active ingredient, compounding exemptions, and sport-rule prohibitions.
Read our status methodology →