{"formats":[{"name":"JSON","format":"json","url":"\/downloads\/2025\/code-json\/54.1-3408.05.json"},{"name":"Plain Text","format":"text","url":"\/downloads\/2025\/code-text\/54.1-3408.05.txt"},{"name":"XML","format":"xml","url":"\/downloads\/2025\/code-xml\/54.1-3408.05.xml"},{"name":"HTML","format":"html","url":"\/downloads\/2025\/code-html\/54.1-3408.05.html"}],"law_id":58824,"edition_id":1,"section_id":58824,"structure_id":13871,"section_number":"54.1-3408.05","catch_line":"Use of FDA-approved substance upon publication of final rule","history":"2017, cc. 416, 432.","full_text":"Except as otherwise provided in this chapter, no person shall be prosecuted under Chapter 7 (\u00a7 18.2-247 et seq.) of Title 18.2 for acting in accordance with \u00a7 54.1-3421 or for prescribing, administering, dispensing, or possessing pursuant to a valid prescription issued by a prescriber any substance that has been approved as a prescription drug by the U.S. Food and Drug Administration pursuant to 21 U.S.C. \u00a7 360bb and 21 U.S.C. \u00a7 355 on or after July 1, 2017, in accordance with any final or interim final order or rule issued pursuant to 21 U.S.C. \u00a7 811(j). Such immunity from prosecution for a particular substance shall remain in effect until the earlier of (i) nine months as calculated from the latter of the date of the publication in the Federal Register of the interim final order or rule scheduling such substance or the final order or rule scheduling such substance, provided that a final order or rule is issued within nine months of the interim final order or rule, or (ii) such substance being added to a schedule in Article 5 (\u00a7 54.1-3443 et seq.) pursuant to \u00a7 54.1-3443 or by enactment into law.","order_by":null,"text":{"0":{"id":215530,"text":"Except as otherwise provided in this chapter, no person shall be prosecuted under Chapter 7 (\u00a7 18.2-247 et seq.) of Title 18.2 for acting in accordance with \u00a7 54.1-3421 or for prescribing, administering, dispensing, or possessing pursuant to a valid prescription issued by a prescriber any substance that has been approved as a prescription drug by the U.S. Food and Drug Administration pursuant to 21 U.S.C. \u00a7 360bb and 21 U.S.C. \u00a7 355 on or after July 1, 2017, in accordance with any final or interim final order or rule issued pursuant to 21 U.S.C. \u00a7 811(j). Such immunity from prosecution for a particular substance shall remain in effect until the earlier of (i) nine months as calculated from the latter of the date of the publication in the Federal Register of the interim final order or rule scheduling such substance or the final order or rule scheduling such substance, provided that a final order or rule is issued within nine months of the interim final order or rule, or (ii) such substance being added to a schedule in Article 5 (\u00a7 54.1-3443 et seq.) pursuant to \u00a7 54.1-3443 or by enactment into law.","type":"section","prefixes":[""],"prefix":"","entire_prefix":"","prefix_anchor":"","level":1}},"ancestry":[{"id":13871,"edition_id":1,"name":"General Provisions","identifier":"1","label":"article","depth":4,"order_by":1,"parent_id":13240,"metadata":{},"date_created":"2026-06-26 03:46:08","date_modified":"2026-06-26 03:46:08","permalink":{"id":243225,"object_type":"structure","relational_id":13871,"identifier":"1","token":"54.1\/III\/34\/1","url":"\/54.1\/III\/34\/1\/","edition_id":1,"permalink":0,"preferred":1}},{"id":13240,"edition_id":1,"name":"Drug Control Act","identifier":"34","label":"chapter","depth":3,"order_by":1,"parent_id":12758,"metadata":{},"date_created":"2026-06-26 03:44:30","date_modified":"2026-06-26 03:44:30","permalink":{"id":243223,"object_type":"structure","relational_id":13240,"identifier":"34","token":"54.1\/III\/34","url":"\/54.1\/III\/34\/","edition_id":1,"permalink":0,"preferred":1}},{"id":12758,"edition_id":1,"name":"Professions and Occupations Regulated by Boards Within the Department of Health Professions","identifier":"III","label":"subtitle","depth":2,"order_by":1,"parent_id":12754,"metadata":{},"date_created":"2026-06-26 03:43:51","date_modified":"2026-06-26 03:43:51","permalink":{"id":241105,"object_type":"structure","relational_id":12758,"identifier":"III","token":"54.1\/III","url":"\/54.1\/III\/","edition_id":1,"permalink":0,"preferred":1}},{"id":12754,"edition_id":1,"name":"Professions and Occupations","identifier":"54.1","label":"title","depth":1,"order_by":1,"parent_id":null,"metadata":{},"date_created":"2026-06-26 03:43:51","date_modified":"2026-06-26 03:43:51","permalink":{"id":239313,"object_type":"structure","relational_id":12754,"identifier":"54.1","token":"54.1","url":"\/54.1\/","edition_id":1,"permalink":0,"preferred":1}}],"structure_contents":[{"id":77846,"structure_id":13871,"section_number":"54.1-3400","catch_line":"Citation","url":"\/54.1-3400\/","token":"54.1\/III\/34\/1\/54.1-3400","metadata":false},{"id":59669,"structure_id":13871,"section_number":"54.1-3401","catch_line":"Definitions","url":"\/54.1-3401\/","token":"54.1\/III\/34\/1\/54.1-3401","metadata":false},{"id":73061,"structure_id":13871,"section_number":"54.1-3401.1","catch_line":"Repealed","url":"\/54.1-3401.1\/","token":"54.1\/III\/34\/1\/54.1-3401.1","metadata":false},{"id":67762,"structure_id":13871,"section_number":"54.1-3402","catch_line":"Repealed","url":"\/54.1-3402\/","token":"54.1\/III\/34\/1\/54.1-3402","metadata":false},{"id":66637,"structure_id":13871,"section_number":"54.1-3403","catch_line":"Chapter not applicable to economic poisons","url":"\/54.1-3403\/","token":"54.1\/III\/34\/1\/54.1-3403","metadata":false},{"id":64371,"structure_id":13871,"section_number":"54.1-3404","catch_line":"Inventories of controlled substances required of certain persons; contents and form of record","url":"\/54.1-3404\/","token":"54.1\/III\/34\/1\/54.1-3404","metadata":false},{"id":55711,"structure_id":13871,"section_number":"54.1-3405","catch_line":"Access to and copies of records; inspections","url":"\/54.1-3405\/","token":"54.1\/III\/34\/1\/54.1-3405","metadata":false},{"id":69269,"structure_id":13871,"section_number":"54.1-3406","catch_line":"Records confidential; disclosure of information about violations of federal law","url":"\/54.1-3406\/","token":"54.1\/III\/34\/1\/54.1-3406","metadata":false},{"id":62600,"structure_id":13871,"section_number":"54.1-3407","catch_line":"Analysis of controlled substances","url":"\/54.1-3407\/","token":"54.1\/III\/34\/1\/54.1-3407","metadata":false},{"id":77665,"structure_id":13871,"section_number":"54.1-3408","catch_line":"Professional use by practitioners","url":"\/54.1-3408\/","token":"54.1\/III\/34\/1\/54.1-3408","metadata":false},{"id":68723,"structure_id":13871,"section_number":"54.1-3408.01","catch_line":"Requirements for prescriptions","url":"\/54.1-3408.01\/","token":"54.1\/III\/34\/1\/54.1-3408.01","metadata":false},{"id":69355,"structure_id":13871,"section_number":"54.1-3408.02","catch_line":"Transmission of prescriptions","url":"\/54.1-3408.02\/","token":"54.1\/III\/34\/1\/54.1-3408.02","metadata":false},{"id":81842,"structure_id":13871,"section_number":"54.1-3408.03","catch_line":"Dispensing of therapeutically equivalent drug product permitted","url":"\/54.1-3408.03\/","token":"54.1\/III\/34\/1\/54.1-3408.03","metadata":false},{"id":61115,"structure_id":13871,"section_number":"54.1-3408.04","catch_line":"Dispensing of interchangeable biosimilars permitted","url":"\/54.1-3408.04\/","token":"54.1\/III\/34\/1\/54.1-3408.04","metadata":false},{"id":58824,"structure_id":13871,"section_number":"54.1-3408.05","catch_line":"Use of FDA-approved substance upon publication of final rule","url":"\/54.1-3408.05\/","token":"54.1\/III\/34\/1\/54.1-3408.05","metadata":false},{"id":82403,"structure_id":13871,"section_number":"54.1-3408.1","catch_line":"Prescription in excess of recommended dosage in certain cases","url":"\/54.1-3408.1\/","token":"54.1\/III\/34\/1\/54.1-3408.1","metadata":false},{"id":54900,"structure_id":13871,"section_number":"54.1-3408.2","catch_line":"Failure to report administration or dispensing of or prescription for controlled substances; report required; penalty","url":"\/54.1-3408.2\/","token":"54.1\/III\/34\/1\/54.1-3408.2","metadata":false},{"id":66341,"structure_id":13871,"section_number":"54.1-3408.3","catch_line":"Certification for use of cannabis for treatment","url":"\/54.1-3408.3\/","token":"54.1\/III\/34\/1\/54.1-3408.3","metadata":false},{"id":84329,"structure_id":13871,"section_number":"54.1-3408.4","catch_line":"Expired","url":"\/54.1-3408.4\/","token":"54.1\/III\/34\/1\/54.1-3408.4","metadata":false},{"id":64050,"structure_id":13871,"section_number":"54.1-3408.5","catch_line":"Epinephrine required in certain places of public accommodation","url":"\/54.1-3408.5\/","token":"54.1\/III\/34\/1\/54.1-3408.5","metadata":false},{"id":86191,"structure_id":13871,"section_number":"54.1-3409","catch_line":"Professional use by veterinarians","url":"\/54.1-3409\/","token":"54.1\/III\/34\/1\/54.1-3409","metadata":false},{"id":83740,"structure_id":13871,"section_number":"54.1-3410","catch_line":"When pharmacist may sell and dispense drugs","url":"\/54.1-3410\/","token":"54.1\/III\/34\/1\/54.1-3410","metadata":false},{"id":56420,"structure_id":13871,"section_number":"54.1-3410.1","catch_line":"Requirements for radiopharmaceuticals","url":"\/54.1-3410.1\/","token":"54.1\/III\/34\/1\/54.1-3410.1","metadata":false},{"id":84268,"structure_id":13871,"section_number":"54.1-3410.2","catch_line":"Compounding; pharmacists' authority to compound under certain conditions; labeling and record maintenance requirements","url":"\/54.1-3410.2\/","token":"54.1\/III\/34\/1\/54.1-3410.2","metadata":false},{"id":70552,"structure_id":13871,"section_number":"54.1-3410.3","catch_line":"Accessible prescription labels","url":"\/54.1-3410.3\/","token":"54.1\/III\/34\/1\/54.1-3410.3","metadata":false},{"id":77643,"structure_id":13871,"section_number":"54.1-3411","catch_line":"When prescriptions may be refilled","url":"\/54.1-3411\/","token":"54.1\/III\/34\/1\/54.1-3411","metadata":false},{"id":61132,"structure_id":13871,"section_number":"54.1-3411.1","catch_line":"Prohibition on returns, exchanges, or re-dispensing of drugs; exceptions","url":"\/54.1-3411.1\/","token":"54.1\/III\/34\/1\/54.1-3411.1","metadata":false},{"id":65473,"structure_id":13871,"section_number":"54.1-3411.2","catch_line":"Prescription drug disposal programs","url":"\/54.1-3411.2\/","token":"54.1\/III\/34\/1\/54.1-3411.2","metadata":false},{"id":86720,"structure_id":13871,"section_number":"54.1-3411.2:1","catch_line":"Guidelines for disposal of unused drugs","url":"\/54.1-3411.2_1\/","token":"54.1\/III\/34\/1\/54.1-3411.2_1","metadata":false},{"id":79333,"structure_id":13871,"section_number":"54.1-3412","catch_line":"Date of dispensing; initials of pharmacist; automated data processing system","url":"\/54.1-3412\/","token":"54.1\/III\/34\/1\/54.1-3412","metadata":false},{"id":84967,"structure_id":13871,"section_number":"54.1-3413","catch_line":"Manufacturing and administering Schedule I drugs","url":"\/54.1-3413\/","token":"54.1\/III\/34\/1\/54.1-3413","metadata":false},{"id":72920,"structure_id":13871,"section_number":"54.1-3414","catch_line":"Official orders for Schedule II drugs","url":"\/54.1-3414\/","token":"54.1\/III\/34\/1\/54.1-3414","metadata":false},{"id":75448,"structure_id":13871,"section_number":"54.1-3415","catch_line":"Distribution of drugs in Schedules II through VI by manufacturers and wholesalers","url":"\/54.1-3415\/","token":"54.1\/III\/34\/1\/54.1-3415","metadata":false},{"id":65722,"structure_id":13871,"section_number":"54.1-3415.1","catch_line":"Delivery of medical devices on behalf of a medical equipment supplier","url":"\/54.1-3415.1\/","token":"54.1\/III\/34\/1\/54.1-3415.1","metadata":false},{"id":81317,"structure_id":13871,"section_number":"54.1-3416","catch_line":"No prescription for preparations listed pursuant to Schedule V","url":"\/54.1-3416\/","token":"54.1\/III\/34\/1\/54.1-3416","metadata":false},{"id":85551,"structure_id":13871,"section_number":"54.1-3417","catch_line":"Disposing of stocks of Schedules II through V drugs","url":"\/54.1-3417\/","token":"54.1\/III\/34\/1\/54.1-3417","metadata":false},{"id":57515,"structure_id":13871,"section_number":"54.1-3418","catch_line":"Sale of aqueous or oleaginous solutions","url":"\/54.1-3418\/","token":"54.1\/III\/34\/1\/54.1-3418","metadata":false},{"id":72600,"structure_id":13871,"section_number":"54.1-3419","catch_line":"Dispensing of insulin preparations","url":"\/54.1-3419\/","token":"54.1\/III\/34\/1\/54.1-3419","metadata":false},{"id":83366,"structure_id":13871,"section_number":"54.1-3420","catch_line":"Distribution of certain drugs; written request or confirmation of receipt","url":"\/54.1-3420\/","token":"54.1\/III\/34\/1\/54.1-3420","metadata":false},{"id":79253,"structure_id":13871,"section_number":"54.1-3420.1","catch_line":"Identification required for filling prescriptions","url":"\/54.1-3420.1\/","token":"54.1\/III\/34\/1\/54.1-3420.1","metadata":false},{"id":56483,"structure_id":13871,"section_number":"54.1-3420.2","catch_line":"Delivery of prescription drug order","url":"\/54.1-3420.2\/","token":"54.1\/III\/34\/1\/54.1-3420.2","metadata":false},{"id":55265,"structure_id":13871,"section_number":"54.1-3420.3","catch_line":"Prohibition on refusing to fill prescription from telemedicine provider","url":"\/54.1-3420.3\/","token":"54.1\/III\/34\/1\/54.1-3420.3","metadata":false},{"id":55995,"structure_id":13871,"section_number":"54.1-3421","catch_line":"New drugs","url":"\/54.1-3421\/","token":"54.1\/III\/34\/1\/54.1-3421","metadata":false},{"id":73818,"structure_id":13871,"section_number":"54.1-3422","catch_line":"Controlled substances registration certificate required in addition to other requirements; exemptions","url":"\/54.1-3422\/","token":"54.1\/III\/34\/1\/54.1-3422","metadata":false},{"id":87135,"structure_id":13871,"section_number":"54.1-3423","catch_line":"Board to issue registration unless inconsistent with public interest; authorization to conduct research; application and fees","url":"\/54.1-3423\/","token":"54.1\/III\/34\/1\/54.1-3423","metadata":false},{"id":59124,"structure_id":13871,"section_number":"54.1-3424","catch_line":"Suspension or revocation of registration, license or permit; limitation to particular controlled substance; controlled substances placed under seal; sale of perishables and forfeiture; notification to DEA","url":"\/54.1-3424\/","token":"54.1\/III\/34\/1\/54.1-3424","metadata":false},{"id":83858,"structure_id":13871,"section_number":"54.1-3425","catch_line":"Repealed","url":"\/54.1-3425\/","token":"54.1\/III\/34\/1\/54.1-3425","metadata":false},{"id":86762,"structure_id":13871,"section_number":"54.1-3426","catch_line":"Regulations for special packaging","url":"\/54.1-3426\/","token":"54.1\/III\/34\/1\/54.1-3426","metadata":false},{"id":85278,"structure_id":13871,"section_number":"54.1-3427","catch_line":"Dispensing drugs without safety closure container","url":"\/54.1-3427\/","token":"54.1\/III\/34\/1\/54.1-3427","metadata":false},{"id":68396,"structure_id":13871,"section_number":"54.1-3428","catch_line":"Dissemination of information","url":"\/54.1-3428\/","token":"54.1\/III\/34\/1\/54.1-3428","metadata":false},{"id":74207,"structure_id":13871,"section_number":"54.1-3429","catch_line":"Revocation of permit issued to manufacturer, wholesaler or distributor","url":"\/54.1-3429\/","token":"54.1\/III\/34\/1\/54.1-3429","metadata":false},{"id":73141,"structure_id":13871,"section_number":"54.1-3430","catch_line":"Display of permit; permits nontransferable; renewal","url":"\/54.1-3430\/","token":"54.1\/III\/34\/1\/54.1-3430","metadata":false},{"id":76001,"structure_id":13871,"section_number":"54.1-3431","catch_line":"Admission into evidence of certain certificates of analysis","url":"\/54.1-3431\/","token":"54.1\/III\/34\/1\/54.1-3431","metadata":false}],"previous_section":{"id":61115,"structure_id":13871,"section_number":"54.1-3408.04","catch_line":"Dispensing of interchangeable biosimilars permitted","url":"\/54.1-3408.04\/","token":"54.1\/III\/34\/1\/54.1-3408.04","metadata":false},"next_section":{"id":82403,"structure_id":13871,"section_number":"54.1-3408.1","catch_line":"Prescription in excess of recommended dosage in certain cases","url":"\/54.1-3408.1\/","token":"54.1\/III\/34\/1\/54.1-3408.1","metadata":false},"metadata":false,"official_url":"https:\/\/law.lis.virginia.gov\/vacode\/54.1-3408.05\/","history_text":"<p>This law was first created in 2017. The record of its establishment is cataloged in chapters <a href=\"https:\/\/legacylis.virginia.gov\/cgi-bin\/legp604.exe?171+ful+CHAP0416\">416<\/a> and <a href=\"https:\/\/legacylis.virginia.gov\/cgi-bin\/legp604.exe?171+ful+CHAP0432\">432<\/a> of that year\u2019s edition of \u201cActs of Assembly,\u201d the annual state publication listing all changes made to the Code of Virginia in that year.<\/p>","references":false,"refers_to":[{"id":84070,"section_number":"18.2-247","catch_line":"Use of terms \"controlled substances,\" \"marijuana,\" \"Schedules I, II, III, IV, V, and VI,\" \"imitation controlled substance,\" and \"counterfeit controlled substance\" in Title 18.2","order_by":null,"url":"\/18.2-247\/"},{"id":55995,"section_number":"54.1-3421","catch_line":"New drugs","order_by":null,"url":"\/54.1-3421\/"},{"id":66818,"section_number":"54.1-3443","catch_line":"Board to administer article","order_by":null,"url":"\/54.1-3443\/"}],"permalink":{"id":243283,"object_type":"law","relational_id":58824,"identifier":"54.1-3408.05","token":"54.1\/III\/34\/1\/54.1-3408.05","url":"\/54.1-3408.05\/","edition_id":1,"permalink":0,"preferred":1},"url":"\/54.1-3408.05\/","token":"54.1\/III\/34\/1\/54.1-3408.05","dublin_core":{"Title":"Use of FDA-approved substance upon publication of final rule","Type":"Text","Format":"text\/html","Identifier":"\u00a7 54.1-3408.05","Relation":"Code of Virginia"},"html":"\n\t\t\t\t\t\t<section><p>Except as otherwise provided in this chapter, no <span class=\"dictionary\">person<\/span> shall be prosecuted under Chapter 7 (\u00a7&nbsp;<a class=\"law\" title=\"Use of terms &quot;controlled substances,&quot; &quot;marijuana,&quot; &quot;Schedules I, II, III, IV, V, and VI,&quot; &quot;imitation controlled substance,&quot; and &quot;counterfeit controlled substance&quot; in Title 18.2\" href=\"\/18.2-247\/\">18.2-247<\/a> et seq.) of Title 18.2 for acting in accordance with \u00a7&nbsp;<a class=\"law\" title=\"New drugs\" href=\"\/54.1-3421\/\">54.1-3421<\/a> or for prescribing, administering, <span class=\"dictionary\">dispensing<\/span>, or possessing pursuant to a valid prescription issued by a <span class=\"dictionary\">prescriber<\/span> any substance that has been approved as a <span class=\"dictionary\">prescription drug<\/span> by the U.S. Food and Drug Administration pursuant to 21 U.S.C. \u00a7&nbsp;360bb and 21 U.S.C. \u00a7&nbsp;355 on or after July 1, 2017, in accordance with any final or interim <span class=\"dictionary\">final order<\/span> or rule issued pursuant to 21 U.S.C. \u00a7&nbsp;811(j). Such immunity from <span class=\"dictionary\">prosecution<\/span> for a particular substance shall remain in effect until the earlier of (i) nine months as calculated from the latter of the date of the publication in the Federal Register of the interim <span class=\"dictionary\">final order<\/span> or rule scheduling such substance or the <span class=\"dictionary\">final order<\/span> or rule scheduling such substance, provided that a <span class=\"dictionary\">final order<\/span> or rule is issued within nine months of the interim <span class=\"dictionary\">final order<\/span> or rule, or (ii) such substance being added to a schedule in Article 5 (\u00a7&nbsp;<a class=\"law\" title=\"Board to administer article\" href=\"\/54.1-3443\/\">54.1-3443<\/a> et seq.) pursuant to \u00a7&nbsp;<a class=\"law\" title=\"Board to administer article\" href=\"\/54.1-3443\/\">54.1-3443<\/a> or by enactment into <span class=\"dictionary\">law<\/span>.<\/p><\/section>","plain_text":"                                 CODE OF VIRGINIA\n\nUSE OF FDA-APPROVED SUBSTANCE UPON PUBLICATION OF FINAL RULE (\u00a7 54.1-3408.05)\n\nExcept as otherwise provided in this chapter, no person shall be prosecuted\nunder Chapter 7 (\u00a7 18.2-247 et seq.) of Title 18.2 for acting in accordance\nwith \u00a7 54.1-3421 or for prescribing, administering, dispensing, or possessing\npursuant to a valid prescription issued by a prescriber any substance that has\nbeen approved as a prescription drug by the U.S. Food and Drug Administration\npursuant to 21 U.S.C. \u00a7 360bb and 21 U.S.C. \u00a7 355 on or after July 1, 2017, in\naccordance with any final or interim final order or rule issued pursuant to 21\nU.S.C. \u00a7 811(j). Such immunity from prosecution for a particular substance\nshall remain in effect until the earlier of (i) nine months as calculated from\nthe latter of the date of the publication in the Federal Register of the interim\nfinal order or rule scheduling such substance or the final order or rule\nscheduling such substance, provided that a final order or rule is issued within\nnine months of the interim final order or rule, or (ii) such substance being\nadded to a schedule in Article 5 (\u00a7 54.1-3443 et seq.) pursuant to \u00a7 54.1-3443\nor by enactment into law.\n\nHISTORY: 2017, cc. 416, 432.","edition":{"id":1,"name":"2025","slug":"2025","date_created":"2026-06-21 22:39:22","date_modified":"2026-06-21 22:39:22","current":1,"order_by":1,"last_import":null}}