Farmacopea De Los - Estados Unidos Mexicanos
Includes standards for:
Una de las contribuciones más valiosas y distintivas de la FEUM es su tratamiento de la herbolaria mexicana. Mientras que farmacopeas de países desarrollados ignoran plantas como el Galphimia glauca (micrópalo) o el Hintonia latiflora (copalchi), la FEUM ha desarrollado monografías específicas para estos recursos terapéuticos tradicionales.
Esto permite que los laboratorios mexicanos produzcan fitofármacos con rigurosidad científica, estandarizando compuestos marcadores (por ejemplo, arbutina para la gayuba). Así, se valida la medicina tradicional dentro del marco de la medicina basada en evidencia.
The Farmacopea de los Estados Unidos Mexicanos is a cornerstone of Mexican pharmaceutical regulation. It functions simultaneously as a scientific reference and a legal instrument, with binding force equal to health laws. For any company or professional involved in medicines in Mexico — from R&D to pharmacy shelves — understanding and applying FEUM is essential.
While challenges like update lag and resource constraints persist, ongoing harmonization with international pharmacopoeias and digital modernization are strengthening its role in ensuring safe, effective, and high-quality medicines for the Mexican population.
The Farmacopea de los Estados Unidos Mexicanos (FEUM) is the official document issued by the Mexican Ministry of Health through COFEPRIS that establishes the quality standards for medicines and health supplies in Mexico. Core Features of the FEUM farmacopea de los estados unidos mexicanos
Official Legal Status: It is a legally binding compendium mandated by the General Health Law (Ley General de Salud) to regulate the identity, purity, and quality of pharmaceutical products.
Comprehensive Monographs: Detailed descriptions for active pharmaceutical ingredients (APIs), excipients, and finished dosage forms, including requirements for:
Qualitative/Quantitative Analysis: Standards for identification and potency. Purity: Limits for contaminants and impurities.
Packaging: Requirements for primary and secondary containers.
Diverse Specialized Publications: Beyond the main allopathic volume, the FEUM includes specialized compendiums: Includes standards for: Una de las contribuciones más
Herbal Pharmacopoeia (Farmacopea Herbolaria): Standards for medicinal plants and traditional remedies.
Homeopathic Pharmacopoeia: Specific rules for homeopathic preparations.
Medical Devices Supplement: Extensive guidelines for equipment, prosthetics, and diagnostic agents.
Establishment Supplement: Standards for pharmacies and storage/distribution facilities.
Standardized Analytical Methods: Provides universal General Methods of Analysis (MGA) to ensure consistency in testing across the industry. Con el aumento del cáncer en México, la
Regular Updates: The publication is periodically revised; the 13th Edition was launched in 2022, followed by Supplement 13.1 in 2023. Key Regulatory Functions Perspectives for licensing vaccines in Mexico - PMC
4. Pharmacopoeia of the united states of Mexico. The Pharmacopoeia of the United States of Mexico (FEUM as abbreviated in Spanish) PubMed Central (PMC) (.gov)
Con el aumento del cáncer en México, la FEUM ha priorizado monografías de quimioterapias como carboplatino, paclitaxel y doxorrubicina liposomal.
The Farmacopea de los Estados Unidos Mexicanos (FEUM) is the official compendium of pharmaceutical standards in Mexico. It establishes mandatory quality, purity, identity, and analytical specifications for pharmaceutical ingredients, medicines, and medical devices. Legally enforced by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) and the Ministry of Health, the FEUM ensures the safety, efficacy, and quality of health supplies for the Mexican population.
Un medicamento puede ser perfecto, pero si el envase lo contamina o degrada, es inútil. La FEUM incluye monografías para frascos de vidrio tipo I, II y III, tapones de hule, blísteres de aluminio y plásticos.
