{"formats":[{"name":"JSON","format":"json","url":"\/downloads\/2025\/code-json\/54.1-3434.5.json"},{"name":"Plain Text","format":"text","url":"\/downloads\/2025\/code-text\/54.1-3434.5.txt"},{"name":"XML","format":"xml","url":"\/downloads\/2025\/code-xml\/54.1-3434.5.xml"},{"name":"HTML","format":"html","url":"\/downloads\/2025\/code-html\/54.1-3434.5.html"}],"law_id":85801,"edition_id":1,"section_id":85801,"structure_id":15723,"section_number":"54.1-3434.5","catch_line":"Nonresident outsourcing facilities to register with the Board","history":"2015, c. 300.","full_text":"A\n\nAny outsourcing facility located outside the Commonwealth that ships, mails, or delivers in any manner Schedule II through VI drugs or devices into the Commonwealth shall be considered a nonresident outsourcing facility and shall be registered with the Board.B\n\nApplications for registration to act as a non-resident outsourcing facility shall be made on a form provided by the Board and signed by a pharmacist who is licensed as a pharmacist in Virginia and who is in full and actual charge of the outsourcing facility, is fully engaged in the compounding performed at the location stated on the application, and is fully responsible for the outsourcing facility’s compliance with state and federal law and regulations. Such application shall be accompanied by a fee determined by the Board in regulation. All registrations shall expire annually on a date determined by the Board in regulation.C\n\nAs a prerequisite to registering or renewing a registration with the Board, the outsourcing facility shall (i) register as an outsourcing facility with the U.S. Secretary of Health and Human Services in accordance with 21 U.S.C. § 353b and (ii) submit a copy of a current inspection report resulting from an inspection conducted by the U.S. Food and Drug Administration that indicates compliance with the requirements of state and federal law and regulations, including all applicable guidance documents and Current Good Manufacturing Practices published by the U.S. Food and Drug Administration.\n\t\t\tThe inspection report required pursuant to clause (ii) shall be deemed current for the purposes of this section if the inspection was conducted (a) no more than one year prior to the date of submission of an application for registration with the Board or (b) no more than two years prior to the date of submission of an application for renewal of a registration with the Board. However, if the outsourcing facility has not been inspected by the U.S. Food and Drug Administration within the required period, the Board may accept an inspection report or other documentation from another entity that is satisfactory to the Board, or the Board may cause an inspection to be conducted by its duly authorized agent and may charge an inspection fee in an amount sufficient to cover the costs of the inspection.D\n\nA nonresident outsourcing facility shall not engage in compounding of drug products to be dispensed pursuant to a valid prescription for a specific patient without first obtaining a registration to operate a nonresident pharmacy. The nonresident pharmacy shall comply with all state and federal laws, regulations, and requirements except § 54.1-3410.2.","order_by":null,"text":{"0":{"id":307269,"text":"Any outsourcing facility located outside the Commonwealth that ships, mails, or delivers in any manner Schedule II through VI drugs or devices into the Commonwealth shall be considered a nonresident outsourcing facility and shall be registered with the Board.","type":"section","prefixes":["A"],"prefix":"A","entire_prefix":"A","prefix_anchor":"A","level":1,"next_prefix":"B"},"1":{"id":307270,"text":"Applications for registration to act as a non-resident outsourcing facility shall be made on a form provided by the Board and signed by a pharmacist who is licensed as a pharmacist in Virginia and who is in full and actual charge of the outsourcing facility, is fully engaged in the compounding performed at the location stated on the application, and is fully responsible for the outsourcing facility’s compliance with state and federal law and regulations. Such application shall be accompanied by a fee determined by the Board in regulation. All registrations shall expire annually on a date determined by the Board in regulation.","type":"section","prefixes":["B"],"prefix":"B","entire_prefix":"B","prefix_anchor":"B","level":1,"prior_prefix":"A","next_prefix":"C"},"2":{"id":307271,"text":"As a prerequisite to registering or renewing a registration with the Board, the outsourcing facility shall (i) register as an outsourcing facility with the U.S. Secretary of Health and Human Services in accordance with 21 U.S.C. § 353b and (ii) submit a copy of a current inspection report resulting from an inspection conducted by the U.S. Food and Drug Administration that indicates compliance with the requirements of state and federal law and regulations, including all applicable guidance documents and Current Good Manufacturing Practices published by the U.S. Food and Drug Administration.\n\t\t\tThe inspection report required pursuant to clause (ii) shall be deemed current for the purposes of this section if the inspection was conducted (a) no more than one year prior to the date of submission of an application for registration with the Board or (b) no more than two years prior to the date of submission of an application for renewal of a registration with the Board. However, if the outsourcing facility has not been inspected by the U.S. Food and Drug Administration within the required period, the Board may accept an inspection report or other documentation from another entity that is satisfactory to the Board, or the Board may cause an inspection to be conducted by its duly authorized agent and may charge an inspection fee in an amount sufficient to cover the costs of the inspection.","type":"section","prefixes":["C"],"prefix":"C","entire_prefix":"C","prefix_anchor":"C","level":1,"prior_prefix":"B","next_prefix":"D"},"3":{"id":307272,"text":"A nonresident outsourcing facility shall not engage in compounding of drug products to be dispensed pursuant to a valid prescription for a specific patient without first obtaining a registration to operate a nonresident pharmacy. The nonresident pharmacy shall comply with all state and federal laws, regulations, and requirements except § 54.1-3410.2.","type":"section","prefixes":["D"],"prefix":"D","entire_prefix":"D","prefix_anchor":"D","level":1,"prior_prefix":"C"}},"ancestry":[{"id":15723,"edition_id":1,"name":"Registration of Nonresident Pharmacies","identifier":"2.1","label":"article","depth":4,"order_by":1,"parent_id":13240,"metadata":{},"date_created":"2026-06-26 03:58:22","date_modified":"2026-06-26 03:58:22","permalink":{"id":243473,"object_type":"structure","relational_id":15723,"identifier":"2.1","token":"54.1\/III\/34\/2.1","url":"\/54.1\/III\/34\/2.1\/","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":77369,"structure_id":15723,"section_number":"54.1-3434.1","catch_line":"Nonresident pharmacies to register with Board","url":"\/54.1-3434.1\/","token":"54.1\/III\/34\/2.1\/54.1-3434.1","metadata":false},{"id":61468,"structure_id":15723,"section_number":"54.1-3434.2","catch_line":"Permit to be issued","url":"\/54.1-3434.2\/","token":"54.1\/III\/34\/2.1\/54.1-3434.2","metadata":false},{"id":87354,"structure_id":15723,"section_number":"54.1-3434.3","catch_line":"Denial, revocation, suspension of registration, summary proceedings","url":"\/54.1-3434.3\/","token":"54.1\/III\/34\/2.1\/54.1-3434.3","metadata":false},{"id":60281,"structure_id":15723,"section_number":"54.1-3434.4","catch_line":"Prohibited acts","url":"\/54.1-3434.4\/","token":"54.1\/III\/34\/2.1\/54.1-3434.4","metadata":false},{"id":85801,"structure_id":15723,"section_number":"54.1-3434.5","catch_line":"Nonresident outsourcing facilities to register with the Board","url":"\/54.1-3434.5\/","token":"54.1\/III\/34\/2.1\/54.1-3434.5","metadata":false}],"previous_section":{"id":60281,"structure_id":15723,"section_number":"54.1-3434.4","catch_line":"Prohibited acts","url":"\/54.1-3434.4\/","token":"54.1\/III\/34\/2.1\/54.1-3434.4","metadata":false},"metadata":false,"official_url":"https:\/\/law.lis.virginia.gov\/vacode\/54.1-3434.5\/","history_text":"

This law was first created in 2015. The record of its establishment is cataloged in chapter 300<\/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":84268,"section_number":"54.1-3410.2","catch_line":"Compounding; pharmacists' authority to compound under certain conditions; labeling and record maintenance requirements","order_by":null,"url":"\/54.1-3410.2\/"}],"permalink":{"id":243491,"object_type":"law","relational_id":85801,"identifier":"54.1-3434.5","token":"54.1\/III\/34\/2.1\/54.1-3434.5","url":"\/54.1-3434.5\/","edition_id":1,"permalink":0,"preferred":1},"url":"\/54.1-3434.5\/","token":"54.1\/III\/34\/2.1\/54.1-3434.5","dublin_core":{"Title":"Nonresident outsourcing facilities to register with the Board","Type":"Text","Format":"text\/html","Identifier":"\u00a7 54.1-3434.5","Relation":"Code of Virginia"},"html":"\n\t\t\t\t\t\t

A.<\/span> Any outsourcing facility<\/span> located outside the Commonwealth that ships, mails, or delivers<\/span> in any manner Schedule II through VI drugs<\/span> or devices<\/span> into the Commonwealth shall be considered a nonresident outsourcing facility<\/span> and shall be registered with the Board<\/span>. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

B.<\/span> Applications for registration to act as a non-resident outsourcing facility<\/span> shall be made on a form provided by the Board<\/span> and signed by a pharmacist who is licensed as a pharmacist in Virginia and who is in full and actual charge of the outsourcing facility<\/span>, is fully engaged in the compounding<\/span> performed at the location stated on the application, and is fully responsible for the outsourcing facility<\/span>’s compliance with state and federal law<\/span> and regulations. Such application shall be accompanied by a fee determined by the Board<\/span> in regulation. All registrations shall expire annually on a date determined by the Board<\/span> in regulation. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

C.<\/span> As a prerequisite to registering or renewing a registration with the Board<\/span>, the outsourcing facility<\/span> shall (i) register as an outsourcing facility<\/span> with the U.S. Secretary of Health and Human Services in accordance with 21 U.S.C. § 353b and (ii) submit a copy of a current inspection report resulting from an inspection conducted by the U.S. Food and Drug<\/span> Administration that indicates compliance with the requirements of state and federal law<\/span> and regulations, including all applicable guidance documents and Current Good Manufacturing Practices published by the U.S. Food and Drug<\/span> Administration.\n\t\t\tThe inspection report required pursuant to clause (ii) shall be deemed current for the purposes of this section if the inspection was conducted (a) no more than one year prior to the date of submission of an application for registration with the Board<\/span> or (b) no more than two years prior to the date of submission of an application for renewal of a registration with the Board<\/span>. However, if the outsourcing facility<\/span> has not been inspected by the U.S. Food and Drug<\/span> Administration within the required period, the Board<\/span> may accept an inspection report or other documentation from another entity that is satisfactory to the Board<\/span>, or the Board<\/span> may cause an inspection to be conducted by its duly authorized agent<\/span> and may charge an inspection fee in an amount sufficient to cover the costs of the inspection. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

D.<\/span> A nonresident outsourcing facility<\/span> shall not engage in compounding<\/span> of drug products<\/span> to be dispensed pursuant to a valid prescription<\/span> for a specific patient without first obtaining a registration to operate a nonresident pharmacy. The nonresident pharmacy shall comply with all state and federal laws<\/span>, regulations, and requirements except § 54.1-3410.2<\/a>. <\/i><\/a><\/p><\/section>","plain_text":" CODE OF VIRGINIA\n\nNONRESIDENT OUTSOURCING FACILITIES TO REGISTER WITH THE BOARD (\u00a7 54.1-3434.5)\n\nA. Any outsourcing facility located outside the Commonwealth that ships, mails,\nor delivers in any manner Schedule II through VI drugs or devices into the\nCommonwealth shall be considered a nonresident outsourcing facility and shall be\nregistered with the Board.\n\nB. Applications for registration to act as a non-resident outsourcing facility\nshall be made on a form provided by the Board and signed by a pharmacist who is\nlicensed as a pharmacist in Virginia and who is in full and actual charge of the\noutsourcing facility, is fully engaged in the compounding performed at the\nlocation stated on the application, and is fully responsible for the outsourcing\nfacility’s compliance with state and federal law and regulations. Such\napplication shall be accompanied by a fee determined by the Board in regulation.\nAll registrations shall expire annually on a date determined by the Board in\nregulation.\n\nC. As a prerequisite to registering or renewing a registration with the Board,\nthe outsourcing facility shall (i) register as an outsourcing facility with the\nU.S. Secretary of Health and Human Services in accordance with 21 U.S.C. §\n353b and (ii) submit a copy of a current inspection report resulting from an\ninspection conducted by the U.S. Food and Drug Administration that indicates\ncompliance with the requirements of state and federal law and regulations,\nincluding all applicable guidance documents and Current Good Manufacturing\nPractices published by the U.S. Food and Drug Administration.\n\t\t\tThe inspection report required pursuant to clause (ii) shall be deemed\ncurrent for the purposes of this section if the inspection was conducted (a) no\nmore than one year prior to the date of submission of an application for\nregistration with the Board or (b) no more than two years prior to the date of\nsubmission of an application for renewal of a registration with the Board.\nHowever, if the outsourcing facility has not been inspected by the U.S. Food and\nDrug Administration within the required period, the Board may accept an\ninspection report or other documentation from another entity that is\nsatisfactory to the Board, or the Board may cause an inspection to be conducted\nby its duly authorized agent and may charge an inspection fee in an amount\nsufficient to cover the costs of the inspection.\n\nD. A nonresident outsourcing facility shall not engage in compounding of drug\nproducts to be dispensed pursuant to a valid prescription for a specific patient\nwithout first obtaining a registration to operate a nonresident pharmacy. The\nnonresident pharmacy shall comply with all state and federal laws, regulations,\nand requirements except § 54.1-3410.2.\n\nHISTORY: 2015, c. 300.","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}}