Mexico publishes NOM-253-SSA1-2025 to regulate the disposal of human blood

The Ministry of Health published the Official Mexican Standard NOM-253-SSA1-2025, For the disposition of human blood and its components for therapeutic purposes, in the Official Gazette of the Federation on Monday, October 12, 2026. The document, which spans pages 107 to 235 of edition 279/2026, is mandatory throughout the national territory for personnel of public, social, and private establishments that perform blood disposition acts. The standard replaces NOM-253-SSA1-2012 and will enter into force 180 calendar days after its publication.

The standard was issued by Víctor Hugo Borja Aburto, Federal Commissioner for the Protection against Sanitary Risks and president of the National Consultative Committee for Standardization of Sanitary Regulation and Promotion, dated September 4, 2026. Its immediate predecessor is the project NOM-253-SSA1-2024, published on November 8, 2024, for a 60-calendar-day public consultation, the comments of which were addressed before the final version.

According to the recitals, the update responds to the scientific and technological advances recorded since 2012 in the knowledge of blood, its components, and transfusion-transmissible diseases. The stated objective is to guarantee the self-sufficiency, quality, and therapeutic safety of blood components, as well as the maximum reduction of risks, with uniform conditions in the blood services of the National Health System.

Scope and structure

The standard regulates the procurement, collection, analysis, preservation, preparation, supply, use, and final destination of blood and blood products for therapeutic purposes. Blood derivatives—albumin, immunoglobulins, and coagulation factor concentrates, among others—are outside its scope, as they are governed by other provisions of the General Health Law.

The text is organized into 25 chapters and four normative appendices:

• Chapters 1 to 5: objective, references, definitions, and general provisions.
• Chapters 6 to 9: information and informed consent, donor selection, extraction, and processing.
• Chapters 10 to 17: analytical determinations, unit identification, transfusional use, autologous use, transfer, and final destination.
• Chapters 18 to 25: transfusion medicine committee, reports to the Ministry, records, international concordance, compliance, surveillance, and validity.
• Appendices A to D: therapeutic procedures, quality control, packaging and transport, and blood service activities.

New analytical requirements

Chapter 10 mandates that, for every donation and before releasing the unit for therapeutic use, tests for the detection of transfusion-transmissible infectious agents must be performed. These must mandatorily include antigens, antibodies, and viral nucleic acids (DNA and RNA), with the minimum detection limits established by the World Health Organization.

The determinations cover, among other agents:

• Human immunodeficiency virus types 1 and 2 (p24 antigen, antibodies, and RNA).
• Hepatitis B virus (surface antigen and DNA).
• Hepatitis C virus (antibodies and RNA).
• Trypanosoma cruzi.
• Treponema pallidum.

Committees, reports, and deadlines

All establishments performing blood disposition acts must have a Transfusion Medicine Committee, which shall meet at least every three months and audit at least 1% of the records of transfused patients each quarter. The committee shall report five indicators monthly: donor deferral rate, complaints regarding blood products, donor complaints, non-conformities of materials and equipment, and serious adverse events.

Reports shall be submitted to the Secretariat of Health through the SANGRHE platform within the first eight calendar days of the month following the reporting period; non-compliance leaves the blood service subject to sanctions. To obtain access, a current sanitary license and notice of sanitary responsible party before COFEPRIS, as well as the CLUES, are required.

The transitional articles set specific deadlines:

• General entry into force: 180 calendar days after publication.
• Nucleic acid amplification tests and irregular antibody screening: 180 calendar days following the entry into force.
• Sanitary license procedures submitted before the effective date: shall be resolved according to previous provisions.

Institutional participation

The following entities, among others, participated in the drafting of the standard: the General Directorate of Epidemiology, the National Blood Transfusion Center, CENETEC, COFEPRIS, IMSS, ISSSTE, Petróleos Mexicanos, the National Polytechnic Institute, the Mexican Red Cross, the Mexican Association of Transfusion Medicine, and Plasma Que Salva, as well as the state transfusion services of Baja California Sur, Durango, Puebla, San Luis Potosí, and Sonora, and the secretariats of National Defense and the Navy.

Compliance monitoring shall be the responsibility of the Ministry of Health and the governments of the federal entities. With the entry into force of NOM-253-SSA1-2025, blood banks, collection centers, processing centers, and transfusion services throughout the country will have to update their procedures, reinforce the molecular detection of infectious agents, and report their operations monthly to the health authority, in order to increase the safety of the transfusion chain for donors and recipients.

Source: Official Gazette of the Federation, No. 279/2026, Monday, October 12, 2026, Section I (Ministry of Health), p. 107 (official reference: NOM-253-SSA1-2025).