{"formats":[{"name":"JSON","format":"json","url":"\/downloads\/2025\/code-json\/54.1-3442.01.json"},{"name":"Plain Text","format":"text","url":"\/downloads\/2025\/code-text\/54.1-3442.01.txt"},{"name":"XML","format":"xml","url":"\/downloads\/2025\/code-xml\/54.1-3442.01.xml"},{"name":"HTML","format":"html","url":"\/downloads\/2025\/code-html\/54.1-3442.01.html"}],"law_id":62677,"edition_id":1,"section_id":62677,"structure_id":14166,"section_number":"54.1-3442.01","catch_line":"Registration of nonresident manufacturer; renewal","history":"2016, c. 221.","full_text":"A\n\nAny manufacturer located outside the Commonwealth who ships prescription drugs into the Commonwealth shall be registered with the Board. The nonresident manufacturer shall renew such registration annually on a date determined by the Board in regulation and shall notify the Board within 30 days of any substantive change in the information previously submitted.B\n\nThe nonresident manufacturer shall at all times maintain a valid, unexpired license, permit, or registration in the state in which it is located or current registration as a manufacturer or repackager with the federal Food and Drug Administration and shall furnish proof of such upon application and at each renewal.C\n\nRecords of prescription drugs distributed into the Commonwealth shall be maintained in such a manner that they are readily retrievable from records of shipments into other jurisdictions and shall be provided to the Board, its authorized agent, or any agent designated by the Superintendent of the Department of State Police upon request within seven days of receipt of such request.","order_by":null,"text":{"0":{"id":228530,"text":"Any manufacturer located outside the Commonwealth who ships prescription drugs into the Commonwealth shall be registered with the Board. The nonresident manufacturer shall renew such registration annually on a date determined by the Board in regulation and shall notify the Board within 30 days of any substantive change in the information previously submitted.","type":"section","prefixes":["A"],"prefix":"A","entire_prefix":"A","prefix_anchor":"A","level":1,"next_prefix":"B"},"1":{"id":228531,"text":"The nonresident manufacturer shall at all times maintain a valid, unexpired license, permit, or registration in the state in which it is located or current registration as a manufacturer or repackager with the federal Food and Drug Administration and shall furnish proof of such upon application and at each renewal.","type":"section","prefixes":["B"],"prefix":"B","entire_prefix":"B","prefix_anchor":"B","level":1,"prior_prefix":"A","next_prefix":"C"},"2":{"id":228532,"text":"Records of prescription drugs distributed into the Commonwealth shall be maintained in such a manner that they are readily retrievable from records of shipments into other jurisdictions and shall be provided to the Board, its authorized agent, or any agent designated by the Superintendent of the Department of State Police upon request within seven days of receipt of such request.","type":"section","prefixes":["C"],"prefix":"C","entire_prefix":"C","prefix_anchor":"C","level":1,"prior_prefix":"B"}},"ancestry":[{"id":14166,"edition_id":1,"name":"Permitting of Manufacturers","identifier":"4","label":"article","depth":4,"order_by":1,"parent_id":13240,"metadata":{},"date_created":"2026-06-26 03:47:06","date_modified":"2026-06-26 03:47:06","permalink":{"id":243553,"object_type":"structure","relational_id":14166,"identifier":"4","token":"54.1\/III\/34\/4","url":"\/54.1\/III\/34\/4\/","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":55332,"structure_id":14166,"section_number":"54.1-3437","catch_line":"Permit to manufacture drugs","url":"\/54.1-3437\/","token":"54.1\/III\/34\/4\/54.1-3437","metadata":false},{"id":84440,"structure_id":14166,"section_number":"54.1-3437.1","catch_line":"Limited permit for repackaging drugs","url":"\/54.1-3437.1\/","token":"54.1\/III\/34\/4\/54.1-3437.1","metadata":false},{"id":68991,"structure_id":14166,"section_number":"54.1-3438","catch_line":"Manufacturing, etc., of drugs or proprietary medicines, to be supervised by pharmacist","url":"\/54.1-3438\/","token":"54.1\/III\/34\/4\/54.1-3438","metadata":false},{"id":82036,"structure_id":14166,"section_number":"54.1-3439","catch_line":"Application for nonrestricted manufacturing permit; fee","url":"\/54.1-3439\/","token":"54.1\/III\/34\/4\/54.1-3439","metadata":false},{"id":78693,"structure_id":14166,"section_number":"54.1-3440","catch_line":"Persons to whom nonrestricted permit is granted","url":"\/54.1-3440\/","token":"54.1\/III\/34\/4\/54.1-3440","metadata":false},{"id":74824,"structure_id":14166,"section_number":"54.1-3441","catch_line":"Restricted manufacturing permit; application; fee; separate application and permit for each place of manufacturing","url":"\/54.1-3441\/","token":"54.1\/III\/34\/4\/54.1-3441","metadata":false},{"id":84721,"structure_id":14166,"section_number":"54.1-3442","catch_line":"When permit not to be granted; regulations","url":"\/54.1-3442\/","token":"54.1\/III\/34\/4\/54.1-3442","metadata":false},{"id":62677,"structure_id":14166,"section_number":"54.1-3442.01","catch_line":"Registration of nonresident manufacturer; renewal","url":"\/54.1-3442.01\/","token":"54.1\/III\/34\/4\/54.1-3442.01","metadata":false},{"id":75222,"structure_id":14166,"section_number":"54.1-3442.02","catch_line":"Prescription drug price transparency","url":"\/54.1-3442.02\/","token":"54.1\/III\/34\/4\/54.1-3442.02","metadata":false}],"previous_section":{"id":84721,"structure_id":14166,"section_number":"54.1-3442","catch_line":"When permit not to be granted; regulations","url":"\/54.1-3442\/","token":"54.1\/III\/34\/4\/54.1-3442","metadata":false},"next_section":{"id":75222,"structure_id":14166,"section_number":"54.1-3442.02","catch_line":"Prescription drug price transparency","url":"\/54.1-3442.02\/","token":"54.1\/III\/34\/4\/54.1-3442.02","metadata":false},"metadata":false,"official_url":"https:\/\/law.lis.virginia.gov\/vacode\/54.1-3442.01\/","history_text":"

This law was first created in 2016. The record of its establishment is cataloged in chapter 221<\/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":false,"permalink":{"id":243583,"object_type":"law","relational_id":62677,"identifier":"54.1-3442.01","token":"54.1\/III\/34\/4\/54.1-3442.01","url":"\/54.1-3442.01\/","edition_id":1,"permalink":0,"preferred":1},"url":"\/54.1-3442.01\/","token":"54.1\/III\/34\/4\/54.1-3442.01","dublin_core":{"Title":"Registration of nonresident manufacturer; renewal","Type":"Text","Format":"text\/html","Identifier":"\u00a7 54.1-3442.01","Relation":"Code of Virginia"},"html":"\n\t\t\t\t\t\t

A.<\/span> Any manufacturer<\/span> located outside the Commonwealth who ships prescription drugs<\/span> into the Commonwealth shall be registered with the Board<\/span>. The nonresident manufacturer<\/span> shall renew such registration annually on a date determined by the Board<\/span> in regulation and shall notify the Board<\/span> within 30 days of any substantive change in the information previously submitted. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

B.<\/span> The nonresident manufacturer<\/span> shall at all times maintain a valid, unexpired license, permit, or registration in the state in which it is located or current registration as a manufacturer<\/span> or repackager with the federal Food and Drug<\/span> Administration and shall furnish proof of such upon application and at each renewal. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

C.<\/span> Records of prescription drugs<\/span> distributed into the Commonwealth shall be maintained in such a manner that they are readily retrievable from records of shipments into other jurisdictions<\/span> and shall be provided to the Board<\/span>, its authorized agent<\/span>, or any agent<\/span> designated by the Superintendent of the Department of State Police upon request within seven days of receipt of such request. <\/i><\/a><\/p><\/section>","plain_text":" CODE OF VIRGINIA\n\nREGISTRATION OF NONRESIDENT MANUFACTURER; RENEWAL (\u00a7 54.1-3442.01)\n\nA. Any manufacturer located outside the Commonwealth who ships prescription\ndrugs into the Commonwealth shall be registered with the Board. The nonresident\nmanufacturer shall renew such registration annually on a date determined by the\nBoard in regulation and shall notify the Board within 30 days of any substantive\nchange in the information previously submitted.\n\nB. The nonresident manufacturer shall at all times maintain a valid, unexpired\nlicense, permit, or registration in the state in which it is located or current\nregistration as a manufacturer or repackager with the federal Food and Drug\nAdministration and shall furnish proof of such upon application and at each\nrenewal.\n\nC. Records of prescription drugs distributed into the Commonwealth shall be\nmaintained in such a manner that they are readily retrievable from records of\nshipments into other jurisdictions and shall be provided to the Board, its\nauthorized agent, or any agent designated by the Superintendent of the\nDepartment of State Police upon request within seven days of receipt of such\nrequest.\n\nHISTORY: 2016, c. 221.","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}}