{"id":2857,"date":"2018-03-15T18:10:48","date_gmt":"2018-03-15T18:10:48","guid":{"rendered":"http:\/\/stagewp.westernu.edu\/research\/?page_id=2857"},"modified":"2024-03-07T18:38:25","modified_gmt":"2024-03-07T18:38:25","slug":"controlled-substances","status":"publish","type":"page","link":"https:\/\/stagewp.westernu.edu\/research\/committees\/institutional-animal-care-and-use-committee\/controlled-substances\/","title":{"rendered":"Controlled Substances"},"content":{"rendered":"<section class=\"hero-secondary\">\n  <div class=\"relative bg-black\">\n                <img decoding=\"async\" class=\"adhere object-cover\" src=\"\/media\/westernu\/basic-slider\/slide-default-00.jpg\" alt=\"slide-default-00\">\n      <div class=\"adhere gradient-overlay\"><\/div>\n        <div class=\"relative container pt-56 md:pt-112 pb-144 md:pb-192\">\n      <div class=\"md:flex md:justify-between px-12\">\n        <div class=\"sm:w-8\/12 md:w-6\/12 xl:w-5\/12 px-12\">\n                      <div class=\"mb-20\">\n              <div class=\"block font-sans font-bold text-14 text-white leading-130\">\n  <span class=\"inline-block\">\n    <a href=\"\/\" class=\"block hover:underline\">WesternU<\/a>\n  <\/span>\n      <span class=\"inline-block mx-6\">\/<\/span>\n          <a href=\"https:\/\/stagewp.westernu.edu\/research\" class=\"inline-block hover:underline\">Research and Biotechnology<\/a>\n          <span class=\"inline-block mx-6\">\/<\/span>\n      <a href=\"https:\/\/stagewp.westernu.edu\/research\/committees\/\" class=\"inline-block hover:underline\">Research Regulatory Affairs<\/a>\n    <span class=\"inline-block mx-6\">\/<\/span>\n      <a href=\"https:\/\/stagewp.westernu.edu\/research\/committees\/institutional-animal-care-and-use-committee\/\" class=\"inline-block hover:underline\">Institutional Animal Care and Use Committee<\/a>\n    <span class=\"inline-block mx-6\">\/<\/span>\n    <span class=\"inline-block\"><\/span>\n  <\/div>            <\/div>\n                                        <h1 class=\"t-h1-sans  text-white\"><\/h1>\n        <\/div>\n              <\/div>\n    <\/div>\n  <\/div>\n<\/section>\n\n\n<section class=\"relative my-48 md:my-72\">\n  <div class=\"container\">\n    <div class=\"lg:flex px-12 lg:justify-start\">\n              <div class=\"w-full lg:w-5\/12 2xl:w-4\/12 -mt-80 md:-mt-112 mb-48 px-12 lg:pr-32\">\n                              <nav class=\"py-28 px-40 2xl:px-64 rounded-5 md:rounded-8 bg-gray-darker text-white mb-40\">\n            <ul>\n                                              <li class=\"block my-8\">\n                  <a class=\"text-22 font-normal leading-130 tracking-20 text-white hover:text-yellow transition-default\" href=\"https:\/\/stagewp.westernu.edu\/research\/committees\/citi-training\/\" target=\"_self\" rel=\"noopener\">CITI (Collaborative Institutional Training Initiative)<\/a>\n                <\/li>\n                                              <li class=\"block my-8\">\n                  <a class=\"text-22 font-normal leading-130 tracking-20 text-white hover:text-yellow transition-default\" href=\"https:\/\/stagewp.westernu.edu\/research\/lab-safety-guide\/\" target=\"_self\" rel=\"noopener\">Lab Safety Guide<\/a>\n                <\/li>\n                          <\/ul>\n          <\/nav>\n                            <\/div>\n      \n      \n                  \n                  \n      <div class=\"w-full px-24 wysiwyg-content lg:w-7\/12 2xl:w-7\/12\">\n        <p>Most research involving the use of animals requires the use of controlled substances as part of the experimental design or euthanasia protocol. Institutions that receive federal research funds, such as WesternU, are expected to adhere to the standards set forth in the\u00a0<em>Guide for the Care and Use of Laboratory Animals<\/em>\u00a0which states, \u201cAll those involved in animal care and use must comply with federal laws and regulations regarding human and veterinary drugs and treatments. Drug records and storage procedures should be reviewed during facility inspections.\u201d<\/p>\n<p>&nbsp;<\/p>\n\n      <\/div>\n    <\/div>\n  <\/div>\n<\/section>\n\n\n<section class=\"relative my-48 md:my-72\">\n  <div class=\"container\">\n    <div class=\"lg:flex px-12 lg:justify-center\">\n      \n      \n                  \n                  \n      <div class=\"w-full px-24 wysiwyg-content xl:w-10\/12 2xl:w-9\/12\">\n        <p>The IACUC has, therefore, established a written\u00a0policy <a href=\"https:\/\/westernu-83220a1bb607c8.sharepoint.com\/sites\/policies\/PolicyPortal\/Pages\/TreeView.aspx\">(IACUC Policy 2014-050)<\/a>\u00a0governing the acquisition, use, storage and disposal of controlled substances used in teaching or research activities involving animals at any WesternU owned or operated facility. Please take note of\u00a0<strong>Section B<\/strong>\u00a0of the Policy which restricts the use of controlled substances in research to persons registered with the DEA and authorized persons under the direct supervision of a registered investigator. This means that <strong>a\u00a0<\/strong><strong>Principal Investigator, or a collaborator, on a protocol that requires the use of a controlled substance, must obtain their own DEA registration.<\/strong>\u00a0They may not piggyback on the registration of an investigator who is not a key participant in the protocol.<\/p>\n<p>DEA Registrants must\u00a0<em>provide a copy of their registration to the IACUC Office.<\/em><em> Registrants must then complete the <\/em><a href=\"\/media\/research\/docs\/Controlled-Subs-Authorized-Users-Form-1.docx\">Controlled Substances Authorized Users form<\/a>.\u00a0A copy of the completed form must be kept with the Registrant\u2019s Controlled Substances Usage Log and another copy must be submitted to the Controlled Substances Program Manager at <a href=\"mailto:IACUCOffice@westernu.edu\">IACUCOffice@westernu.edu<\/a>. A new copy of the form must be submitted to the Program Manager whenever there is a change in Authorized Users. <a href=\"https:\/\/westernu.sharepoint.com\/:b:\/r\/sites\/ResearchandBiotechnology\/Forms\/Non-public%20Documents\/Safety_Compliance\/A_SOP-Controlled-Substances-Program-Manager.pdf?csf=1&amp;web=1&amp;e=5xqS6O\" target=\"_blank\" rel=\"noopener\">Description of the responsibilities of the Program Manager<\/a>.<\/p>\n<p style=\"text-align: left;\"><em><strong>All animal users listed on an IACUC-approved protocol must complete the on-line Controlled Substances training on <\/strong><\/em><a href=\"https:\/\/elearning.westernu.edu\/\"><strong>eLearning<\/strong><\/a><em>. A user name and password is required to access this site<\/em>. Newly submitted IACUC protocols that involve the use of controlled substances will not be reviewed, and active protocols could be suspended, in the absence of proof of DEA registration by the investigator and completion of the required training.<\/p>\n<p>The IACUC\u2019s standardized controlled substances usage and inventory forms are\u00a0<strong>required<\/strong>\u00a0to be used by all registered investigators who use controlled substances in research. These forms must be produced on demand by the IACUC during an inspection or by appropriate government officials. Copies of these forms may be obtained by clicking on the links below.<\/p>\n<p>Inventory form for\u00a0<a href=\"https:\/\/stagewp.westernu.edu\/mediafiles\/research\/iacuc\/cONTROLLED_sUBS_iNVENTORY_I.docx\">Schedule I<\/a>\u00a0Controlled Substances<br \/>\nInventory form for\u00a0<a href=\"https:\/\/stagewp.westernu.edu\/mediafiles\/research\/iacuc\/cONTROLLED_sUBS_iNVENTORY_II.docx\">Schedule II<\/a>\u00a0Controlled Substances<br \/>\nInventory form for\u00a0<a href=\"https:\/\/stagewp.westernu.edu\/mediafiles\/research\/iacuc\/cONTROLLED_sUBS_iNVENTORY_III_V.docx\">Schedules III, IV &amp; V<\/a>\u00a0Controlled Substances<br \/>\nControlled Substances\u00a0<a href=\"https:\/\/stagewp.westernu.edu\/mediafiles\/research\/iacuc\/cONTROLLED_sUBS_uSAGE_lOG.docx\">Usage Log<\/a><\/p>\n<p><strong>Controlled substances that are beyond the expiration date printed on the container label by the manufacturer<\/strong>\u00a0<strong>may not, under any circumstances, be used in animals used in teaching or research activities<\/strong>\u00a0at WesternU.\u00a0Disposal of expired or unwanted controlled substances should be returned, if possible, to the vendor from whom they were acquired. Otherwise, investigators must contact a <strong>Reverse Distributor<\/strong> for disposal.<\/p>\n<p>A Reverse Distributor is defined as \u201ca person or entity registered with the DEA as a reverse distributor to acquire controlled substances from another registrant for the purpose of return or destruction of controlled substances\u201d. If returning controlled substances to the distributor from whom they were acquired is not an option, the registrant must contact one of the companies on the following list of DEA\u00a0<a href=\"\/media\/research\/pdfs\/Controlled-Subs-Reverse-Distributors.pdf\">Registered Reverse Distributors<\/a>\u00a0or contact the DEA directly for instructions.<\/p>\n<p>A DEA registrant may authorize one or more individuals to issue orders for Schedule I and II controlled substances on the Registrant\u2019s behalf by executing a\u00a0<a href=\"\/media\/research\/docs\/Controlled-Subs-Power-of-Atty-1.docx\">Power of Attorney form<\/a> for each individual.\u00a0Registrants wishing to do so must follow the instructions provided on the form.\u00a0A copy of each completed form must be kept with the Registrant\u2019s Usage Log and another copy must be submitted to the IACUC Office at <a href=\"mailto:IACUCOffice@westernu.edu\">IACUCOffice@westernu.edu<\/a>.\u00a0A registrant may revoke any power of attorney at any time by following the instructions on the form.\u00a0These form must be available for inspection by the IACUC and authorized persons from appropriate regulatory agencies along with other controlled substances records.<\/p>\n\n      <\/div>\n    <\/div>\n  <\/div>\n<\/section>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":5,"featured_media":0,"parent":17,"menu_order":8,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-2857","page","type-page","status-publish","hentry"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/stagewp.westernu.edu\/research\/wp-json\/wp\/v2\/pages\/2857","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stagewp.westernu.edu\/research\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/stagewp.westernu.edu\/research\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/stagewp.westernu.edu\/research\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/stagewp.westernu.edu\/research\/wp-json\/wp\/v2\/comments?post=2857"}],"version-history":[{"count":21,"href":"https:\/\/stagewp.westernu.edu\/research\/wp-json\/wp\/v2\/pages\/2857\/revisions"}],"predecessor-version":[{"id":5841,"href":"https:\/\/stagewp.westernu.edu\/research\/wp-json\/wp\/v2\/pages\/2857\/revisions\/5841"}],"up":[{"embeddable":true,"href":"https:\/\/stagewp.westernu.edu\/research\/wp-json\/wp\/v2\/pages\/17"}],"wp:attachment":[{"href":"https:\/\/stagewp.westernu.edu\/research\/wp-json\/wp\/v2\/media?parent=2857"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}