{"formats":[{"name":"JSON","format":"json","url":"\/downloads\/2025\/code-json\/54.1-3421.json"},{"name":"Plain Text","format":"text","url":"\/downloads\/2025\/code-text\/54.1-3421.txt"},{"name":"XML","format":"xml","url":"\/downloads\/2025\/code-xml\/54.1-3421.xml"},{"name":"HTML","format":"html","url":"\/downloads\/2025\/code-html\/54.1-3421.html"}],"law_id":55995,"edition_id":1,"section_id":55995,"structure_id":13871,"section_number":"54.1-3421","catch_line":"New drugs","history":"1970, c. 650, \u00a7 54-524.95; 1988, c. 765; 2000, c. 135.","full_text":"A\n\nNo person shall sell, deliver, offer for sale, hold for sale or give away any new drug unless an application with respect to the drug has been approved and the approval has not been withdrawn under &#xA7; 505 of the federal Food, Drug, and Cosmetic Act (21 U.S.C. &#xA7; 355).B\n\nThis section shall not apply to a drug subject to the federal act intended solely for investigational use and for which a notice of claimed investigational exemption for a new drug has been filed with the U.S. Food and Drug Administration in accordance with 21 C.F.R. Part 312.","order_by":null,"text":{"0":{"id":205183,"text":"No person shall sell, deliver, offer for sale, hold for sale or give away any new drug unless an application with respect to the drug has been approved and the approval has not been withdrawn under &#xA7; 505 of the federal Food, Drug, and Cosmetic Act (21 U.S.C. &#xA7; 355).","type":"section","prefixes":["A"],"prefix":"A","entire_prefix":"A","prefix_anchor":"A","level":1,"next_prefix":"B"},"1":{"id":205184,"text":"This section shall not apply to a drug subject to the federal act intended solely for investigational use and for which a notice of claimed investigational exemption for a new drug has been filed with the U.S. Food and Drug Administration in accordance with 21 C.F.R. Part 312.","type":"section","prefixes":["B"],"prefix":"B","entire_prefix":"B","prefix_anchor":"B","level":1,"prior_prefix":"A"}},"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":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},"next_section":{"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},"metadata":false,"official_url":"https:\/\/law.lis.virginia.gov\/vacode\/54.1-3421\/","history_text":"<p>This law was first created in 1970. The record of its establishment is cataloged in chapter 650 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. Unfortunately, the 1970 \u201cActs\u201d aren\u2019t available online. It has been modified 2 times. Those modifications are cataloged by \u201cThe Acts of Assembly,\u201d a state publication, by year and chapter. Those modifications that can be read on the General Assembly\u2019s website will be linked accordingly. Those modifications are as follows: in 1988, chapter 765; in 2000, chapter <a href=\"https:\/\/legacylis.virginia.gov\/cgi-bin\/legp604.exe?001+ful+CHAP0135\">135<\/a>.<\/p>","references":[{"id":58824,"section_number":"54.1-3408.05","catch_line":"Use of FDA-approved substance upon publication of final rule","order_by":null,"url":"\/54.1-3408.05\/"},{"id":83286,"section_number":"54.1-3457","catch_line":"Prohibited acts","order_by":null,"url":"\/54.1-3457\/"},{"id":82436,"section_number":"54.1-3459","catch_line":"Tagging of adulterated or misbranded drugs, devices, or cosmetics; condemnation; destruction; expenses","order_by":null,"url":"\/54.1-3459\/"}],"refers_to":false,"permalink":{"id":243395,"object_type":"law","relational_id":55995,"identifier":"54.1-3421","token":"54.1\/III\/34\/1\/54.1-3421","url":"\/54.1-3421\/","edition_id":1,"permalink":0,"preferred":1},"url":"\/54.1-3421\/","token":"54.1\/III\/34\/1\/54.1-3421","dublin_core":{"Title":"New drugs","Type":"Text","Format":"text\/html","Identifier":"\u00a7 54.1-3421","Relation":"Code of Virginia"},"html":"\n\t\t\t\t\t\t<section id=\"A\"><p><span class=\"prefix-number\">A.<\/span> No <span class=\"dictionary\">person<\/span> shall sell, <span class=\"dictionary\">deliver<\/span>, offer for <span class=\"dictionary\">sale<\/span>, hold for <span class=\"dictionary\">sale<\/span> or give away any <span class=\"dictionary\">new drug<\/span> unless an application with respect to the drug has been approved and the approval has not been withdrawn under &#xA7; 505 of the federal Food, Drug, and Cosmetic Act (21 U.S.C. &#xA7; 355). <a id=\"paragraph-205183\" class=\"section-permalink\" href=\"https:\/\/vacode.org\/54.1-3421\/#A\"><i class=\"fa fa-link\"><\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t<section id=\"B\"><p><span class=\"prefix-number\">B.<\/span> This section shall not apply to a drug subject to the federal act intended solely for investigational use and for which a notice of claimed investigational exemption for a <span class=\"dictionary\">new drug<\/span> has been filed with the U.S. Food and Drug Administration in accordance with 21 C.F.R. Part 312. <a id=\"paragraph-205184\" class=\"section-permalink\" href=\"https:\/\/vacode.org\/54.1-3421\/#B\"><i class=\"fa fa-link\"><\/i><\/a><\/p><\/section>","plain_text":"                                 CODE OF VIRGINIA\n\nNEW DRUGS (\u00a7 54.1-3421)\n\nA. No person shall sell, deliver, offer for sale, hold for sale or give away any\nnew drug unless an application with respect to the drug has been approved and\nthe approval has not been withdrawn under &#xA7; 505 of the federal Food, Drug,\nand Cosmetic Act (21 U.S.C. &#xA7; 355).\n\nB. This section shall not apply to a drug subject to the federal act intended\nsolely for investigational use and for which a notice of claimed investigational\nexemption for a new drug has been filed with the U.S. Food and Drug\nAdministration in accordance with 21 C.F.R. Part 312.\n\nHISTORY: 1970, c. 650, \u00a7 54-524.95; 1988, c. 765; 2000, c. 135.","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}}