{"id":45514,"date":"2026-04-17T12:35:19","date_gmt":"2026-04-17T18:35:19","guid":{"rendered":"http:\/\/10.100.20.231\/normalizacion\/nom-073-ssa1-2015\/"},"modified":"2026-04-17T12:35:19","modified_gmt":"2026-04-17T18:35:19","slug":"nom-073-ssa1-2015","status":"publish","type":"post","link":"http:\/\/10.100.20.231\/normalizacion\/nom-073-ssa1-2015\/","title":{"rendered":"NOM-073-SSA1-2015"},"content":{"rendered":"\r\n<div class=\"wp-container-3 wp-block-group barra intro-interior sin-barra norma-detalles\">\r\n\r\n\r\n<div class=\"wp-block-columns\">\r\n\r\n\r\n\r\n<div class=\"wp-container-2 wp-block-group barra intro-interior sin-barra norma-detalles\">\r\n\r\n\r\n<div class=\"wp-block-columns\">\r\n\r\n\r\n<div class=\"wp-block-column\">\r\n\r\n\r\n<div class=\"wp-container-1 wp-block-group yoast-breadcrumbs\">\r\n\r\n<a href=\"https:\/\/platiica.economia.gob.mx\/\">Inicio<\/a> &gt; <a href=\"https:\/\/platiica.economia.gob.mx\/normalizacion\/\">Normalizaci\u00f3n<\/a> &gt; <a href=\"https:\/\/platiica.economia.gob.mx\/normalizacion\/catalogo-mexicano-de-normas\/\">Cat\u00e1logo Mexicano de Normas<\/a> &gt; NOM-073-SSA1-2015\r\n\r\n<\/div>\r\n\r\n\r\n\r\n<h2 id=\"titulo-blog\">Normas<\/h2>\r\n\r\n\r\n\r\n<h1 class=\"has-medium-font-size\">NOM-073-SSA1-2015<\/h1>\r\n\r\n\r\n<!-- wp:buttons }} -->\r\n<div class=\"wp-block-buttons\">\r\n\r\n\r\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link\" href=\"https:\/\/www.dof.gob.mx\/nota_detalle.php?codigo=5440183&#038;fecha=07\/06\/2016#:~:text=Esta%20Norma%20establece%20las%20especificaciones,aquellos%20medicamentos%20con%20fines%20de&#038;gsc.tab=0\" target=\"_blank\" rel=\"noopener\">Publicaci\u00f3n en el DOF<\/a><\/div>\r\n\r\n\r\n<\/div>\r\n\r\n\r\n\r\n<h3>Informaci\u00f3n principal<\/h3>\r\n\r\n<p style=\"text-align: justify;\"><strong>Clave de la Norma:<\/strong> NOM-073-SSA1-2015<\/p>\r\n<p style=\"text-align: justify;\"><strong>T\u00edtulo de la Norma:<\/strong> Estabilidad de f\u00e1rmacos y medicamentos (modifica a la NOM-073-SSA1-1993, Estabilidad de medicamentos, publicada el 3 de agosto de 1996).<\/p>\r\n<p style=\"text-align: justify;\"><strong>Estado de la Norma:<\/strong> Vigente<\/p>\r\n<p style=\"text-align: justify;\"><strong>Fecha de publicaci\u00f3n en el DOF:<\/strong> 7\/6\/2016<\/p>\r\n<p style=\"text-align: justify;\"><strong>Fecha de entrada en vigor:<\/strong> 4\/12\/2016<\/p>\r\n\r\n<h3>Informaci\u00f3n general<\/h3>\r\n\r\n<p style=\"text-align: justify;\"><strong>Producto, servicio, proceso o sistema:<\/strong> F\u00e1rmacos y medicamentos<\/p>\r\n<p style=\"text-align: justify;\"><strong>Dependencia(s):<\/strong> <ul><li>Secretar\u00eda de Salud<\/li><\/ul><\/p>\r\n<p style=\"text-align: justify;\"><strong>Comit\u00e9 que desarroll\u00f3 la Norma:<\/strong> <ul><li>Comit\u00e9 Consultivo Nacional de Normalizaci\u00f3n de Regulaci\u00f3n y Fomento Sanitario<\/li><\/ul><\/p>\r\n\r\n<h3>Concordancia internacional<\/h3>\r\n\r\n<p style=\"text-align: justify;\"><li><p style=\"text-align: justify;\">Esta Norma es parcialmente equivalente a los est\u00e1ndares internacionales: <\/li><\/p>\n <li><p style=\"text-align: justify;\">European Medicines Agency, Committee for medicinal products for human use &#038; Committee for medicinal products for veterinary use. Guideline on quality of herbal medicinal products\/traditional herbal medicinal products, 2006. <\/li><\/p> \n <li><p style=\"text-align: justify;\">International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Harmonised Tripartite Guideline Q1A (R2): Stability Testing of New Drug Substances and Products <\/li><\/p> \n <li><p style=\"text-align: justify;\">Food and Drug Administration, Center for Drug Evaluation and Research Guidance for Industry: Stability Testing of Drug Substances and Drug Products <\/li><\/p> \n <li><p style=\"text-align: justify;\">International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Harmonised Tripartite Guideline Q1C: Stability Testing for New Dosage Forms <\/li><\/p> \n <li><p style=\"text-align: justify;\">International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Harmonised Tripartite Guideline Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products <\/li><\/p> \n <li><p style=\"text-align: justify;\">International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Harmonised Tripartite Guideline 5C: Quality of Biotechnological Products: Stability Testing of Biotechnological\/Biological Products.<\/li><\/p><\/p>\r\n<p style=\"text-align: justify;\"><strong>Grado:<\/strong> Parcialmente equivalente<\/p>\r\n<p style=\"text-align: justify;\"><h3>Historial Documental de la Norma<\/h3> <ul><li><p style=\"text-align: justify;\"> \n Proyecto de Norma Oficial Mexicana PROY-NOM-073-SSA1-2014, Estabilidad de f\u00e1rmacos y medicamentos, as\u00ed como de remedios herbolarios<\/p> <a target=\"_blank\" href=\"https:\/\/dof.gob.mx\/nota_detalle.php?codigo=5383484&#038;fecha=26\/02\/2015#gsc.tab=0\" rel=\"noopener\"> Enlace<\/a> <\/li><li><p style=\"text-align: justify;\">RESPUESTA a los comentarios recibidos respecto del Proyecto de Norma Oficial Mexicana PROY-NOM-073-SSA1-2014, Estabilidad de f\u00e1rmacos y medicamentos, as\u00ed como de remedios herbolarios, publicado el 26 de febrero de 2015.<\/p> <a target=\"_blank\" href=\"https:\/\/www.dof.gob.mx\/nota_detalle.php?codigo=5437392&#038;fecha=17\/05\/2016#gsc.tab=0\" rel=\"noopener\"> Enlace<\/a> <\/li><li><p style=\"text-align: justify;\">NORMA Oficial Mexicana NOM-073-SSA1-2015, Estabilidad de f\u00e1rmacos y medicamentos, as\u00ed como de remedios herbolarios.<\/p> <a target=\"_blank\" href=\"https:\/\/www.dof.gob.mx\/nota_detalle_popup.php?codigo=5440183\" rel=\"noopener\"> Enlace<\/a> <\/li><\/ul><\/p>\r\n<p style=\"text-align: justify;\"><h3>Referencias Normativas<\/h3> <ul><li><p style=\"text-align: justify;\">NORMA Oficial Mexicana NOM-008-SCFI-2002, Sistema General de Unidades de Medida.<\/p> <a target=\"_blank\" href=\"https:\/\/dof.gob.mx\/nota_detalle.php?codigo=718870&#038;fecha=27\/11\/2002#gsc.tab=0\" rel=\"noopener\"> Enlace<\/a> <\/li>\n <li><p style=\"text-align: justify;\"> \n NORMA Oficial Mexicana NOM-059-SSA1-2013, Buenas pr\u00e1cticas de fabricaci\u00f3n de medicamentos.<\/p> <a target=\"_blank\" href=\"https:\/\/www.dof.gob.mx\/nota_detalle_popup.php?codigo=5307536\" rel=\"noopener\"> Enlace<\/a> <\/li>\n <li><p style=\"text-align: justify;\">NORMA Oficial Mexicana NOM-072-SSA1-2012, Etiquetado de medicamentos y de remedios herbolarios.<\/p> <a target=\"_blank\" href=\"https:\/\/www.dof.gob.mx\/nota_detalle.php?codigo=5278341&#038;fecha=21\/11\/2012#gsc.tab=0\" rel=\"noopener\"> Enlace<\/a> <\/li>\n <li><p style=\"text-align: justify;\">NORMA Oficial Mexicana NOM-164-SSA1-2013, Buenas pr\u00e1cticas de fabricaci\u00f3n para f\u00e1rmacos.<\/p> <a target=\"_blank\" href=\"https:\/\/dof.gob.mx\/nota_detalle.php?codigo=5303768&#038;fecha=25\/06\/2013#gsc.tab=0\" rel=\"noopener\"> Enlace<\/a> <\/li>\n <li><p style=\"text-align: justify;\">NORMA Oficial Mexicana NOM-248-SSA1-2011, Buenas pr\u00e1cticas de fabricaci\u00f3n para establecimientos dedicados a la fabricaci\u00f3n de remedios herbolarios.<\/p> <a target=\"_blank\" href=\"https:\/\/www.dof.gob.mx\/normasOficiales\/4676\/salud\/salud.htm\" rel=\"noopener\"> Enlace<\/a> <\/li>\n <li><p style=\"text-align: justify;\">Farmacopea de los Estados Unidos Mexicanos, edici\u00f3n vigente y sus Suplementos.<\/li><\/p>\n <li><p style=\"text-align: justify;\">International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Harmonised Tripartite Guideline Q1B. Stability Testing: Photo stability Testing of New Drug Substances and Products<\/p> <a target=\"_blank\" href=\"http:www.cofepris.gob.mx\/AS\/Documents\/RegistroSanitarioMedicamentos\/Guias\/Q1B_Guideline%20DEF_ES%20(0).pdf\" rel=\"noopener\"> Enlace<\/a> <\/li>\n <li><p style=\"text-align: justify;\">International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products <\/li><\/p>.\n <li><p style=\"text-align: justify;\">International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q5C Stability testing of biotechnological \/biological products<\/p> <a target=\"_blank\" href=\"International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonized Tripartite Guideline Q5C Stability testing of biotechnological \/ biological products.\" rel=\"noopener\"> Enlace<\/a> <\/li>\n <li><p style=\"text-align: justify;\">International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q1E: Evaluation for Stability Data. <\/p> <a target=\"_blank\" href=\"Evaluation for Stability Data\" rel=\"noopener\"> Enlace<\/a> <\/li> \n <li><p style=\"text-align: justify;\">WHO. Guidelines on stability evaluation of vaccines<\/li><\/p> \n <li><p style=\"text-align: justify;\">WHO. Technical Report Series, No. 992. Annex 4. General guidance on hold-time studies, 2015.<\/li><\/p><\/ul><\/p>\r\n<p style=\"text-align: justify;\"><h3>Bibliograf\u00eda<\/h3> <ul><li><p style=\"text-align: justify;\">Ley General de Salud.<\/p> <a target=\"_blank\" href=\"https:\/\/www.diputados.gob.mx\/LeyesBiblio\/pdf\/LGS.pdf\" rel=\"noopener\"> Enlace<\/a> <\/li>\n <li><p style=\"text-align: justify;\">Ley Federal sobre Metrolog\u00eda y Normalizaci\u00f3n.<\/p> <a target=\"_blank\" href=\"\/\/www.gob.mx\/cms\/uploads\/attachment\/file\/107522\/LEYFEDERALSOBREMETROLOGIAYNORMALIZACION.pdf\" rel=\"noopener\"> Enlace<\/a> <\/li>\n <li><p style=\"text-align: justify;\">Reglamento de Insumos para la Salud.<\/p> <a target=\"_blank\" href=\"https:\/\/salud.gob.mx\/unidades\/cdi\/nom\/compi\/ris.html\" rel=\"noopener\"> Enlace<\/a> <\/li>\n <li><p style=\"text-align: justify;\">Reglamento de la Ley Federal sobre Metrolog\u00eda y Normalizaci\u00f3n.<\/p> <a target=\"_blank\" href=\"https:\/\/www.diputados.gob.mx\/LeyesBiblio\/regley\/Reg_LFMN.pdf\" rel=\"noopener\"> Enlace<\/a> <\/li>\n <li><p style=\"text-align: justify;\">Reglamento de la Comisi\u00f3n Federal para la Protecci\u00f3n contra Riesgos Sanitarios.<\/p> <a target=\"_blank\" href=\"https:\/\/www.diputados.gob.mx\/LeyesBiblio\/regla\/29.PDF\" rel=\"noopener\"> Enlace<\/a> <\/li>\n <li><p style=\"text-align: justify;\">Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Stability Testing of Drug Substances and Drug Products <\/li><\/p>\n <li><p style=\"text-align: justify;\">European Medicines Agency, Committee for medicinal products for human use &#038; Committee for medicinal products for veterinary use. Guideline on quality of herbal medicinal products\/traditional herbal medicinal products<\/li><\/p>\n <li><p style=\"text-align: justify;\">International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q1A (R2): Stability Testing of New Drug Substances and Products <\/li><\/p> \n <li><p style=\"text-align: justify;\">International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q1C: Stability Testing for New Dosage Forms <\/li><\/p> \n <li><p style=\"text-align: justify;\">Health Canada. Guidance for Industry: Stability Testing of Existing Drug Substances and Products, 2003.<\/li><\/p>\n <li><p style=\"text-align: justify;\">Health Canada. Guidance for Industry: Identification, Qualification, and Control of related impurities in Existing Drugs <\/li><\/p> \n <li><p style=\"text-align: justify;\">International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline 5C: Quality of Biotechnological Products: Stability Testing of Biotechnological\/Biological Products.<\/li><\/p>\n <li><p style=\"text-align: justify;\">Scale-up and Post-Approval Changes (SUPAC) Guidance, Immediate Release Solid Oral Dosage Forms: Chemistry, Manufacturing and Controls, In Vitro 1 Dissolution Testing, and In Vivo Bioequivalence Documentation.<\/li><\/p>\n <li><p style=\"text-align: justify;\">Drug Stability: Principles and Practices, Carstensen and Rhodes, Third Edition, USA 2000.<\/li><\/p> <li><p style=\"text-align: justify;\">International Pharmaceutical Product Registration: Stability Data, Cartwright &#038; Matthews, USA 1995.<\/li><\/p> <li><p style=\"text-align: justify;\">International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q3A(R): Impurities in New Drug Substances <\/li><\/p> <li><p style=\"text-align: justify;\">International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q3B(R): Impurities in New Drug Products <\/li><\/p> <li><p style=\"text-align: justify;\">International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q3C: Impurities Residual Solvents<\/li><\/p> \n <li><p style=\"text-align: justify;\">Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry.<\/li><\/p>\n <li><p style=\"text-align: justify;\">ANDAs: Impurities in Drug Products (Dec. 1998).<\/li><\/p>\n <li><p style=\"text-align: justify;\">ANDAs: Impurities in Drug Substances (Nov. 1999).<\/li><\/p> <li><p style=\"text-align: justify;\">Chemical Stability of Pharmaceuticals: A Handbook for Pharmacists, 2nd Edition, Connors K. A., Amidon G. L. and Stella V. J., J. Wiley and Sons, USA (1986).<\/li><\/p> <li><p style=\"text-align: justify;\">World Health Organization. Guidelines on stability evaluation of vaccines Annex_3_WHO_TRS_962-3.<\/li><\/p> \n <li><p style=\"text-align: justify;\">World Health Organization. Technical Report Series, No. 953, 2009. Annex 2, Guidelines for stability testing of active pharmaceutical ingredients and finished pharmaceutical products.<\/li><\/p> <li><p style=\"text-align: justify;\">WHO Technical Report Series, No. 953, 2009. Annex 2, Guidelines for stability testing of active pharmaceutical ingredientes and finished pharmaceutical products, que se ha incluido en la bibliograf\u00eda de la norma. La misma OMS emiti\u00f3 una tabla de las condiciones de temperatura y humedad por pa\u00eds (table 2, stability conditions for WHO Member States by Region)<\/li><\/p><\/ul><\/p>\r\n<p style=\"text-align: justify;\"><h3>Hist\u00f3rico de cancelaciones<\/h3> <ul>NOM-073-SSA1-2005<\/ul><\/p>\r\n<h3>Revisi\u00f3n Sistem\u00e1tica<\/h3> <ul><li>\n  <div class=\"fecha-oficial\"> Fecha de \u00faltima revisi\u00f3n sistem\u00e1tica: <\/div>\n  <div class=\"dato-fecha-oficial\">08 de enero de 2026<\/div>\n  <div class=\"tipo\"> Resultado del informe: <\/div>\n  <div class=\"resolucion\"> Modificaci\u00f3n<\/div>\n  <a target=\"_blank\" href=\"https:\/\/platiica.economia.gob.mx\/wp-content\/uploads\/sites\/2\/InformedeRevision\/NOM-073-SSA1-2015_2026_ultima%20revisi%C3%B3n.pdf?_t=1768580743\" rel=\"noopener\"> Descarga el informe de revisi\u00f3n <\/a> \n <\/li><\/ul>\r\n\r\n<p><strong><a href=\"https:\/\/platiica.economia.gob.mx\/wp-content\/uploads\/sites\/2\/InformedeRevision\/NOM-073-SSA1-2015 _2021_ultima_revision.pdf\"> > Enlace al \u00faltimo Informe de revisi\u00f3n<\/a><\/strong><\/p>\r\n\r\n\r\n\r\n<!-- wp:buttons }} -->\r\n<div class=\"wp-block-buttons\">\r\n\r\n\r\n<div class=\"wp-block-button outline\"><a class=\"wp-block-button__link\" href=\"https:\/\/platiica.economia.gob.mx\/evaluacion-de-la-conformidad\/busqueda-avanzada\/?asp_s=NOM-073-SSA1-2015\">Organismos de Evaluaci\u00f3n de la Conformidad<\/a><\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-button outline\"><a class=\"wp-block-button__link\" href=\"https:\/\/platiica.economia.gob.mx\/verificacion-y-vigilancia\/busqueda-avanzada\/?asp_s=NOM-073-SSA1-2015\">Verificaciones<\/a><\/div>\r\n\r\n\r\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link\" target=\"_blank\" href=\"https:\/\/platiica.economia.gob.mx\/wp-content\/uploads\/sites\/2\/PDF_Normas_Publicas\/073ssa12016.pdf\" rel=\"noopener\">PDF de la Norma<\/a><\/div>\r\n\r\n<\/div>\r\n\r\n\r\n\r\n\r\n\r\n\r\n<\/div>\r\n\r\n\r\n<\/div>\r\n\r\n\r\n<\/div>\r\n\r\n\r\n<\/div>\r\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Estabilidad de f\u00e1rmacos y medicamentos (modifica a la NOM-073-SSA1-1993, Estabilidad de medicamentos, publicada el 3 de agosto de 1996).<\/p>\n","protected":false},"author":40,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_links_to":"","_links_to_target":""},"categories":[328],"tags":[],"_links":{"self":[{"href":"http:\/\/10.100.20.231\/normalizacion\/wp-json\/wp\/v2\/posts\/45514"}],"collection":[{"href":"http:\/\/10.100.20.231\/normalizacion\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/10.100.20.231\/normalizacion\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/10.100.20.231\/normalizacion\/wp-json\/wp\/v2\/users\/40"}],"replies":[{"embeddable":true,"href":"http:\/\/10.100.20.231\/normalizacion\/wp-json\/wp\/v2\/comments?post=45514"}],"version-history":[{"count":0,"href":"http:\/\/10.100.20.231\/normalizacion\/wp-json\/wp\/v2\/posts\/45514\/revisions"}],"wp:attachment":[{"href":"http:\/\/10.100.20.231\/normalizacion\/wp-json\/wp\/v2\/media?parent=45514"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/10.100.20.231\/normalizacion\/wp-json\/wp\/v2\/categories?post=45514"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/10.100.20.231\/normalizacion\/wp-json\/wp\/v2\/tags?post=45514"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}