{"id":2885,"date":"2017-07-13T10:15:42","date_gmt":"2017-07-13T10:15:42","guid":{"rendered":"https:\/\/az.research.umich.edu\/animalcare\/document\/policy-use-non-pharmaceutical-grade-drugs\/"},"modified":"2026-06-02T03:23:05","modified_gmt":"2026-06-02T07:23:05","slug":"policy-use-non-pharmaceutical-grade-drugs","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/animalcare\/policies\/policy-use-non-pharmaceutical-grade-drugs\/","title":{"rendered":"Policy on the Use of Non-Pharmaceutical Grade Drugs"},"template":"","categories":[5,6,7,8,9,10,11,12,13,14,15,16,17,18,19],"tags":[],"content-type":[32],"topic":[34,25],"update-type":[],"class_list":["post-2885","document","type-document","status-publish","hentry","category-cats","category-chickens-avian","category-cows","category-dogs","category-ferrets","category-fish-amphibians-and-reptiles","category-guinea-pigs","category-hamsters","category-mice","category-other-rodents","category-primates","category-rabbits","category-rats","category-sheep","category-swine","content-type-policies","topic-anesthesia-and-analgesia","topic-surgery"],"acf":{"use_legacy_editor":true,"updated_date":"2026-06-01 12:00:00","update_notice":true,"author":"Institutional Animal Care & Use Committee","summary":"","button_links":null,"related_content":[3404,3407,3401,3475,3473],"legacy_path":"policy-use-non-pharmaceutical-grade-drugs","legacy_node_id":30,"legacy_related_nids":"18, 153, 154","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"Purpose","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"This policy defines the expectations for the use of non-pharmaceutical grade substances in animal research. The Guide for the\u00a0Care and Use of Laboratory Animals<\/em>, the Office of Laboratory Animal Welfare (OLAW<\/a>), and the United\u00a0States Department of Agriculture (USDA<\/a>) all state that pharmaceutical-grade chemicals, biologics, and other substances, when available, must be used in laboratory animals. This includes anesthetics, analgesics, and any substances administered experimentally, and apply to non-survival as well as long term studies.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"Applicability","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"This policy is applicable to all animal activities conducted under the auspices of the University and applies to all locations under the purview of the U-M IACUC.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"Glossary Definitions","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"glossary_terms","legacy_heading":"","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":[2726,2725],"legacy_glossary_nids":"1421, 1420","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"Policy","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"
    \r\n \t
  1. Whenever possible, chemicals, biologics, and other substances used in animal research must be pharmaceutical grade.\r\n
      \r\n \t
    1. A database of pharmaceutical grade drugs is available at www.accessdata.fda.gov\/scripts\/cder\/daf<\/a><\/li>\r\n \t
    2. Drug compounds sold by chemical manufacturers (e.g., Sigma-Aldrich\u00ae) are typically reagent grade and NOT pharmaceutical grade.<\/li>\r\n<\/ol>\r\n<\/li>\r\n \t
    3. The use of non-pharmaceutical grade substances in animal-based research requires IACUC\u00a0approval and must be based on either:\r\n
        \r\n \t
      1. Unavailability of an acceptable veterinary or human pharmaceutical-grade compound; or<\/li>\r\n \t
      2. Scientific necessity.<\/li>\r\n<\/ol>\r\n<\/li>\r\n \t
      3. In accordance with the Guide and OLAW, when administering a non-pharmaceutical grade drug to animals, the following must be considered, described, and justified in the animal protocol:\r\n
          \r\n \t
        1. Stability, potency, and sterility of formulation;<\/li>\r\n \t
        2. Storage and preparation procedures; and<\/li>\r\n \t
        3. How expiration or beyond use dates will be determined.<\/li>\r\n<\/ol>\r\n<\/li>\r\n \t
        4. Non-pharmaceutical grade substances are available in a spectrum of quality and consistency. The\u00a0following order of choice should be applied when determining the appropriate substance to use:\r\n
            \r\n \t
          1. Drug formulation prepared using FDA-approved drugs or vehicles (e.g., saline) or acquired from a Pharmacy\u00a0Compounding Accreditation Board or FDA-registered compounding pharmacy.\u200b<\/li>\r\n \t
          2. Drug formulation prepared using USP-NF grade chemicals or substances (generally manufactured under Current Good Manufacturing Practice (CGMP) regulations in an FDA-registered facility with quality control testing.<\/li>\r\n \t
          3. Drug formulations prepared using non-USP grade chemicals or substances.<\/li>\r\n<\/ol>\r\n<\/li>\r\n<\/ol>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"Compliance","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"The provisions of this policy are under the direction and oversight of the U-M\u2019s IACUC. The IACUC will,\u00a0if necessary, suspend research or implement sanctions if policy infractions should occur.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null}],"update_notice_type":[51,53],"update_notice_start":"2026-06-01 22:15:00","update_notice_end":"2026-09-01 22:15:00","update_notice_text_blocks":[{"update_notice_text":"

            Summary of Changes<\/strong><\/span><\/h3>\r\n