Executive summary
Mexico's COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) regulates peptides under the Ley General de Salud (General Health Law). Approved peptide medicines require a sanitary registration. Compounding follows NOM-249-SSA1-2010 (with an updated draft PROY-NOM-249-SSA1-2025). Research-use-only peptide marketing may constitute unauthorized drug promotion or supply where human use is implied, depending on the product, claims and transaction facts.
Authorities and legal categories
COFEPRIS: sanitary registration, pharmacovigilance, enforcement, import control.
SSA (Secretaría de Salud): policy direction.
CIPAM (Comisión Interinstitucional para la Protección contra Riesgos Sanitarios): interagency coordination.
Key instruments:
Ley General de Salud (LGS).
Reglamento de Insumos para la Salud (RIS).
NOM-249-SSA1-2010 / PROY-NOM-249-SSA1-2025 — compounding standards.
Fracción IV, Artículo 226 LGS — classification of substances.
Approved medicines
Approved peptide medicines include GLP-1 receptor agonists (semaglutida/Ozempic, Wegovy; liraglutida/Victoza, Saxenda; tirzepatida/Mounjaro), insulin analogues, teriparatida (Forteo), leuprorelina, octreotida, desmopresina, and calcitonina.
Source: COFEPRIS sanitary register, https://www.gob.mx/cofepris
Compounding/manufacturing
NOM-249-SSA1-2010: governs sterile compounding in healthcare settings. Updated draft PROY-NOM-249-SSA1-2025 introduces stricter quality requirements.
The reviewed NOM-249 material does not establish a US-style section 503A “registered API / identified patient / essentially a copy” test. This page therefore does not declare a research-market peptide eligible or ineligible for magistral preparation without an exact Mexican provision and a licensed- establishment/product-specific assessment.
Import
Import requires a sanitary registration held by the importer or the foreign manufacturer's Mexican legal representative.
Personal import: limited to approved medicines for personal use, with a prescription from a Mexican-licensed physician.
The June 11, 2025 Equivalence Decree simplified registration for medicines approved by reference agencies (FDA, EMA, etc.) but does not waive registration for unapproved peptide products.
Research-use-only products
COFEPRIS does not recognise a research-use-only exemption for products sold to consumers. In April 2026, COFEPRIS issued an alert specifically warning against social-media promotion of unapproved peptide products.
Enforcement examples and uncertainty
April 2026: COFEPRIS alert on social-media peptide product promotion.
2025: Equivalence Decree — semaglutide patent expiry analysis suggests potential for generic approvals, subject to biowaiver requirements.
Uncertainty: the scope of the magistral compounding exception for new peptide substances not in the pharmacopoeia remains untested.
Practical interpretation limits
This is general regulatory research, not legal advice. Classification can turn on composition, claims, intended use, route, supplier role, and facts not captured by a product name.
Primary sources
COFEPRIS. https://www.gob.mx/cofepris
Ley General de Salud. https://www.diputados.gob.mx/LeyesBiblio/ref/lgs.htm
NOM-249-SSA1-2010 (searchable via COFEPRIS or DOF).
PROY-NOM-249-SSA1-2025 (searchable via COFEPRIS regulatory agenda).
COFEPRIS April 2026 Alert. https://www.gob.mx/cofepris (comunicados).