{"id":2289,"date":"2020-10-30T08:30:52","date_gmt":"2020-10-30T12:30:52","guid":{"rendered":"https:\/\/umaine.edu\/research-compliance\/?page_id=2289"},"modified":"2024-06-06T19:16:01","modified_gmt":"2024-06-06T23:16:01","slug":"recordkeeping","status":"publish","type":"page","link":"https:\/\/umaine.edu\/research-compliance\/controlled-substances\/recordkeeping\/","title":{"rendered":"Recordkeeping of Controlled Substances"},"content":{"rendered":"\n

Recordkeeping is a vital part of managing controlled substances (see 21 Code of Federal Regulations (CFR) Title 21 \u00a71304.11 [external link]<\/a>). Complete and accurate records help maintain inventories to avoid diversions and losses. Logbooks and records should be separated from other records and kept near the controlled substance work area. These records must be legible. Events of loss, destruction, or theft must be recorded in detail as well. All records and logbooks must be retained for at least two years from the last entry.<\/p>\n\n\n\n

Records and logbooks should include the following:<\/p>\n\n\n\n

Receipt of Controlled Substances<\/h3>\n\n\n\n

These records should indicate date received, name of supplier, substance name and description, amount received, and authorized person handling the substance. Copies of order forms (Drug Enforcement Administration [DEA] Form 222) must be stored in a securely locked cabinet.<\/p>\n\n\n\n

Use Log of Controlled Substance<\/h3>\n\n\n\n

Each controlled substance should have its own use log. Different substances shouldn\u2019t be recorded interchangeably. Information in the Use Logs should include:<\/p>\n\n\n\n

    \n
  1. Name of Controlled Substance<\/li>\n\n\n\n
  2. Date (i.e. Received, Expired, Each time used)<\/li>\n\n\n\n
  3. Amount (i.e. Initial, Dispensed, Remaining)<\/li>\n\n\n\n
  4. Purpose of use (i.e. Project or Experiment used for)<\/li>\n\n\n\n
  5. Authorized User Name\/Initials<\/li>\n<\/ol>\n\n\n\n

    For administration to animals, also record the following:<\/p>\n\n\n\n

      \n
    1. The individual animal ID of the animal(s) drug was administered to<\/li>\n\n\n\n
    2. A cage or group ID and total number of animals if no individual ID exists<\/li>\n\n\n\n
    3. At minimum, the total number of animals if no cage or group ID exists<\/li>\n<\/ol>\n\n\n\n

      If a volume is removed from a primary bottle to create a dilution\/cocktail in a secondary bottle, the use must be recorded in both bottle logs.<\/p>\n\n\n\n

      Document in the log for the primary bottle:<\/p>\n\n\n\n

        \n
      1. The volume removed to make the secondary dilution\/cocktail<\/li>\n\n\n\n
      2. The identification number for the secondary dilution\/cocktail bottle<\/li>\n<\/ol>\n\n\n\n

        Document in the log for the secondary dilution\/cocktail bottle:<\/p>\n\n\n\n

          \n
        1. The identification number for the originating primary bottle from which the substance was removed<\/li>\n\n\n\n
        2. The volume from the primary bottle used to make the secondary dilution\/cocktail<\/li>\n<\/ol>\n\n\n\n

          Inventory of Controlled Substance<\/h3>\n\n\n\n

          The complete and accurate inventory of controlled substances stocked in each registrant\u2019s lab should be conducted initially when registered and biennially (every two years). These records must be consistent with records of receipt, use, and disposal.<\/p>\n\n\n\n

          The inventory record must contain at a minimum:<\/p>\n\n\n\n

            \n
          1. The date the inventory was completed<\/li>\n\n\n\n
          2. The names of each controlled substance<\/li>\n\n\n\n
          3. The form of the substance (e.g., 20 mg tablet, 50mg\/ml)<\/li>\n\n\n\n
          4. The number of containers of each form and the number of dosage units in each container (e.g. 15.5 mls, 60 pills)<\/li>\n<\/ol>\n\n\n\n

            Note: The information provided above is not intended to cover all of the DEA regulations governing Controlled Substances. Further information on requirements for managing and handling controlled substances can be found on the <\/em>DEA website (external link)<\/a>.<\/em><\/p>\n\n\n\n

            Up Next: Sample Forms for Recordkeeping of Controlled Substances<\/a><\/h3>\n\n\n\n

            Proper Controlled Substance Management Menu<\/h3>\n\n\n\n
              \n
            1. Prior Approval<\/a><\/li>\n\n\n\n
            2. Licensing and Registration for Researchers<\/a><\/li>\n\n\n\n
            3. Storage and Security<\/a><\/li>\n\n\n\n
            4. Disposal<\/a><\/li>\n\n\n\n
            5. Reporting Theft or Loss<\/a><\/li>\n\n\n\n
            6. Recordkeeping [current page]<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

              Recordkeeping is a vital part of managing controlled substances (see 21 Code of Federal Regulations (CFR) Title 21 \u00a71304.11 [external link]). Complete and accurate records help maintain inventories to avoid diversions and losses. Logbooks and records should be separated from other records and kept near the controlled substance work area. These records must be legible. […]<\/p>\n","protected":false},"author":430,"featured_media":0,"parent":2212,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"templates\/page-withsidebar.php","meta":{"_seopress_robots_primary_cat":"","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":"","_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-2289","page","type-page","status-publish","hentry"],"taxonomy_info":[],"featured_image_src_large":false,"author_info":{"display_name":"aashe","author_link":"https:\/\/umaine.edu\/research-compliance\/author\/aashe\/"},"comment_info":"","_links":{"self":[{"href":"https:\/\/umaine.edu\/research-compliance\/wp-json\/wp\/v2\/pages\/2289","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/umaine.edu\/research-compliance\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/umaine.edu\/research-compliance\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/umaine.edu\/research-compliance\/wp-json\/wp\/v2\/users\/430"}],"replies":[{"embeddable":true,"href":"https:\/\/umaine.edu\/research-compliance\/wp-json\/wp\/v2\/comments?post=2289"}],"version-history":[{"count":18,"href":"https:\/\/umaine.edu\/research-compliance\/wp-json\/wp\/v2\/pages\/2289\/revisions"}],"predecessor-version":[{"id":6067,"href":"https:\/\/umaine.edu\/research-compliance\/wp-json\/wp\/v2\/pages\/2289\/revisions\/6067"}],"up":[{"embeddable":true,"href":"https:\/\/umaine.edu\/research-compliance\/wp-json\/wp\/v2\/pages\/2212"}],"wp:attachment":[{"href":"https:\/\/umaine.edu\/research-compliance\/wp-json\/wp\/v2\/media?parent=2289"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}