Farmacopea de los Estados Unidos Mexicanos (FEUM) is the official regulatory document that defines the standards for identity, purity, and quality of medicines and health supplies in Mexico. It is legally mandated by the General Health Law and issued by the Ministry of Health through Legal and Operational Foundation Mandatory Compliance
: The FEUM is compulsory for all establishments involved in the manufacturing, distribution, and sale of medicines and health supplies in Mexico. Governing Body : It is maintained by the Permanent Commission of the FEUM (CPFEUM) , a technical advisory body established in 1984. Regulatory Standard NOM-001-SSA1-2020
dictates the structure and procedures for its continuous revision and update. Transparencia COFEPRIS Current Editions and Supplements
As of recent updates, the FEUM consists of several specialized volumes to address different sectors of the healthcare industry: FEUM - Sitio Web
The Farmacopea de los Estados Unidos Mexicanos (FEUM) is the official mandatory document that establishes the identity, purity, and quality standards for medicines, medical devices, and other healthcare products in Mexico. Core Purpose and Function farmacopea de los estados unidos mexicanos
Official Authority: It is issued by the Secretaría de Salud (Ministry of Health) and serves as the primary legal and technical reference for pharmaceutical quality.
Standardization: The FEUM defines general analysis methods and specific requirements for pharmaceuticals, including additives, biologicals, and biotechnological products.
Public Health Protection: Its central goal is to ensure that all health supplies used by the public meet consistent, high-quality safety standards. Governance and Updates
Supervision: The COFEPRIS (Federal Commission for Protection Against Sanitary Risks) oversees its application. Farmacopea de los Estados Unidos Mexicanos (FEUM) is
Maintenance: The Permanent Commission of the Farmacopea de los Estados Unidos Mexicanos (CPFEUM) acts as the technical advisory body responsible for regular updates and revisions.
Current Editions: The most recent general edition as of late 2021 is FEUM 13.0, alongside the Herbal Pharmacopoeia 3.0 (FHEUM). Structure and Supplements
The FEUM is not a single book but a collection of specialized volumes and supplements designed for different sectors of the healthcare industry: FEUM - Sitio Web
Con el aumento del cáncer en México, la FEUM ha priorizado monografías de quimioterapias como carboplatino, paclitaxel y doxorrubicina liposomal. Responsible Body : Comisión Permanente de la Farmacopea
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.
| Edition | Year | Key Features | |---------|------|---------------| | 1st | 1930 | First official edition; basic analytical methods. | | 2nd–4th | 1939–1952 | Expanded monographs and inclusion of biological products. | | 5th | 1962 | Introduction of modern instrumental analysis (spectrophotometry, chromatography). | | 6th–8th | 1975–1999 | Harmonization efforts with USP and Ph. Eur. standards. | | 9th | 2005 | Major revision; separate supplements for herbal and homeopathic medicines. | | 10th | 2011 | Inclusion of medical devices and raw materials for cosmetics. | | 11th | 2016 | Digital edition; stricter impurity limits (ICH Q3 guidelines). | | 12th | 2021 | Current edition; focus on elemental impurities, genotoxic impurities, and pharmacopoeial harmonization with USP–NF and Ph. Eur. |
Supplements: Published every 6–12 months to keep pace with new drugs and technologies.