Overview
Mexico has no peptide-specific statute; peptides intended for human use are handled under the general medicines framework of the Ley General de Salud, which requires a sanitary registration (registro sanitario) from the health authority before any medicine may be sold or supplied, and channels most injectables through prescription-only categories. Approved peptide drugs such as semaglutide-class products and growth hormone are legally available only as registered products dispensed on prescription. Research peptides such as BPC-157 and TB-500 have no COFEPRIS approval, so selling or supplying them for human use in Mexico is outside the legal registration system, and COFEPRIS has repeatedly issued sanitary alerts against unregistered or falsified weight-loss and hormone products sold online. Personal importation is possible only under COFEPRIS's personal-use import procedure, where the quantity must match a valid medical prescription.
Key Points
- Under Article 376 of the Ley General de Salud, medicines and products containing narcotics or psychotropics require a sanitary registration granted only by the Secretaría de Salud, which is the gateway any peptide drug must pass to be lawfully marketed in Mexico. [1]
- Article 226 of the Ley General de Salud classifies medicines for sale and supply to the public into categories defined by how they may be dispensed, including categories that may only be acquired with a medical prescription. [2]
- COFEPRIS, a decentralized body of the Secretariat of Health formed in 2001, is the federal regulator responsible for health-risk regulation including medicines. [3]
- Research-grade peptides promoted online, including BPC-157, have not been approved for general human use by COFEPRIS or any other health authority, and are commonly sourced from unregulated overseas suppliers. [4]
- In February 2026 COFEPRIS issued a sanitary alert over the illegal marketing of tirzepatide-containing products that lack sanitary registration in Mexico, urging the public not to buy medicines through social media or unauthorized digital platforms. [5]
- COFEPRIS has also issued a sanitary alert regarding falsification and irregular commercialization of the GLP-1 products Ozempic, Wegovy and Saxenda. [6]
- COFEPRIS has separately warned the public about falsified human growth hormone products circulating in Mexico. [7]
- For personal importation, COFEPRIS operates a dedicated procedure in which the imported quantity must correspond to what is covered by the medical prescription, and the filing must be made by the person who purchased the product and is named in the customs pedimento. [8]
- No Mexican statute, scheduling annex, or official COFEPRIS bulletin naming BPC-157 or TB-500 specifically was located in this research; the treatment of those research peptides above is inferred from the general registro sanitario and prescription rules plus press-verified statements that they are unapproved, not from a peptide-specific legal instrument. (No reliable source found for this point -- flagged as unverified rather than stated as fact.)