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.
Popular substances
View allBPC-157
FDA-approved drug product: Not an approved drug
Also known as: 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.
Last verified 2025-03-01Read status →
GHK-Cu
FDA-approved drug product: Not an approved drug
Also known as: 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.
Last verified 2025-03-01Read status →
Ipamorelin
FDA-approved drug product: Not an approved drug
Also known as: 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.
Last verified 2025-03-01Read status →
Melanotan II
FDA-approved drug product: Not an approved drug
Also known as: MT-II, Melanotan 2
A synthetic melanocortin peptide. It is not a component of an FDA-approved drug and has no USP/NF monograph.
Last verified 2025-03-01Read status →
Bremelanotide
FDA-approved drug product: Approved product — specific indication/route
Also known as: PT-141, Vyleesi
A melanocortin receptor agonist peptide. FDA approved it as Vyleesi for a specific premenopausal HSDD indication.
Last verified 2025-03-01Read status →
Retatrutide
FDA-approved drug product: Not an approved drug / investigational
Also known as: 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.
Last verified 2025-03-01Read status →
Semaglutide
FDA-approved drug product: Approved product — specific indication/route
Also known as: Ozempic, Rybelsus, Wegovy
A GLP-1 receptor agonist approved in three FDA-approved products with different routes, indications, and strengths.
Last verified 2025-03-01Read status →
Sermorelin
FDA-approved drug product: Approved product discontinued from marketing
Also known as: 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.
Last verified 2025-03-01Read status →
Tesamorelin
FDA-approved drug product: Approved product — specific indication/route
Also known as: Egrifta, TH9507
A growth hormone-releasing factor analog. FDA has approved it in Egrifta for a specific HIV-associated indication.
Last verified 2025-03-01Read status →
Tirzepatide
FDA-approved drug product: Approved product — specific indication/route
Also known as: 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.
Last verified 2025-03-01Read status →
Claim check
View allmisleadingU.S. federal · 2026-07-23
Does an FDA advisory committee vote approve a peptide?
“The FDA advisory committee voted to approve the peptide.”
An FDA advisory committee vote is a recommendation only. FDA makes the final approval decision, and a recommendation does not change the legal status of a substance.
partly accurateU.S. federal · 2025-02-21
Are compounded GLP-1 products still allowed after shortage resolution?
“Compounded tirzepatide and semaglutide are still legal now that the shortages are over.”
FDA resolved the national shortages of tirzepatide (Dec. 19, 2024) and semaglutide (Feb. 21, 2025). After transition periods, compounded copies are generally subject to the usual 503A/503B copy restrictions; local stock-outs do not create a continuing shortage.
misleadingU.S. federal · 2024-09-27
Is BPC-157 FDA approved?
“BPC-157 is FDA approved / legal to use / a safe peptide.”
As of September 27, 2024, BPC-157 is not an FDA-approved drug, is in Category 2 of the 503A bulk list (significant safety risks), and is prohibited at all times in sport under WADA S0.
misleadingU.S. federal · 2024-12-10
Does 'research use only' mean a peptide is not a drug for human use?
“A product labeled 'research use only' or 'not for human use' is not an FDA-regulated drug.”
FDA looks at intended use, including website claims and marketing context. If the evidence shows the product is intended for human disease treatment, the 'research use only' label does not make it lawful.
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 →