{"formats":[{"name":"JSON","format":"json","url":"\/downloads\/2025\/code-json\/54.1-3435.json"},{"name":"Plain Text","format":"text","url":"\/downloads\/2025\/code-text\/54.1-3435.txt"},{"name":"XML","format":"xml","url":"\/downloads\/2025\/code-xml\/54.1-3435.xml"},{"name":"HTML","format":"html","url":"\/downloads\/2025\/code-html\/54.1-3435.html"}],"law_id":86023,"edition_id":1,"section_id":86023,"structure_id":13241,"section_number":"54.1-3435","catch_line":"License to act as wholesale distributor; renewal; fee","history":"1970, c. 650, \u00a7 54-524.44; 1976, c. 614; 1980, c. 288; 1988, c. 765; 1992, c. 737; 2008, c. 320; 2015, c. 299; 2016, c. 221.","full_text":"A\n\nIt shall be unlawful for any person to engage in the wholesale distribution of prescription drugs in the Commonwealth without a valid unrevoked license issued by the Board. The applicant for licensure as a wholesale distributor, as defined in &#xA7; 54.1-3401, in the Commonwealth shall apply to the Board for a license, using such forms as the Board may furnish; renew such license using such forms as the Board may furnish, if granted, annually on a date determined by the Board in regulation; notify the Board within 30 days of any substantive change in the information reported on the application form previously submitted to the Board; and remit a fee as determined by the Board.B\n\nA wholesale distributor that ceases distribution of Schedule II through V drugs to a pharmacy, licensed physician dispenser, or licensed physician dispensing facility located in the Commonwealth due to suspicious orders of controlled substances shall notify the Board within five days of the cessation. For the purposes of this section, &#8220;suspicious orders of controlled substances&#8221; means, relative to the pharmacy&#8217;s, licensed physician dispenser&#8217;s, or licensed physician dispensing facility&#8217;s order history and the order history of similarly situated pharmacies, licensed physician dispensers, or licensed physician dispensing facilities, (i) orders of unusual size, (ii) orders deviating substantially from a normal pattern, and (iii) orders of unusual frequency.C\n\nA wholesale distributor shall be immune from civil liability for giving notice in accordance with subsection B unless the notice was given in bad faith or with malicious intent.D\n\nThe Board shall not impose any disciplinary or enforcement action against any licensee or permit holder solely on the basis of a notice received from a wholesale distributor pursuant to subsection B.E\n\nThe Board may promulgate such regulations relating to the storage, handling, and distribution of prescription drugs by wholesale distributors as it deems necessary to implement this section, to prevent diversion of prescription drugs, and to protect the public.F\n\nEvery wholesale distributor shall comply with federal requirements for an electronic, interoperable system to identify, trace, and verify prescription drugs as they are distributed.","order_by":null,"text":{"0":{"id":308072,"text":"It shall be unlawful for any person to engage in the wholesale distribution of prescription drugs in the Commonwealth without a valid unrevoked license issued by the Board. The applicant for licensure as a wholesale distributor, as defined in &#xA7; 54.1-3401, in the Commonwealth shall apply to the Board for a license, using such forms as the Board may furnish; renew such license using such forms as the Board may furnish, if granted, annually on a date determined by the Board in regulation; notify the Board within 30 days of any substantive change in the information reported on the application form previously submitted to the Board; and remit a fee as determined by the Board.","type":"section","prefixes":["A"],"prefix":"A","entire_prefix":"A","prefix_anchor":"A","level":1,"next_prefix":"B"},"1":{"id":308073,"text":"A wholesale distributor that ceases distribution of Schedule II through V drugs to a pharmacy, licensed physician dispenser, or licensed physician dispensing facility located in the Commonwealth due to suspicious orders of controlled substances shall notify the Board within five days of the cessation. For the purposes of this section, &#8220;suspicious orders of controlled substances&#8221; means, relative to the pharmacy&#8217;s, licensed physician dispenser&#8217;s, or licensed physician dispensing facility&#8217;s order history and the order history of similarly situated pharmacies, licensed physician dispensers, or licensed physician dispensing facilities, (i) orders of unusual size, (ii) orders deviating substantially from a normal pattern, and (iii) orders of unusual frequency.","type":"section","prefixes":["B"],"prefix":"B","entire_prefix":"B","prefix_anchor":"B","level":1,"prior_prefix":"A","next_prefix":"C"},"2":{"id":308074,"text":"A wholesale distributor shall be immune from civil liability for giving notice in accordance with subsection B unless the notice was given in bad faith or with malicious intent.","type":"section","prefixes":["C"],"prefix":"C","entire_prefix":"C","prefix_anchor":"C","level":1,"prior_prefix":"B","next_prefix":"D"},"3":{"id":308075,"text":"The Board shall not impose any disciplinary or enforcement action against any licensee or permit holder solely on the basis of a notice received from a wholesale distributor pursuant to subsection B.","type":"section","prefixes":["D"],"prefix":"D","entire_prefix":"D","prefix_anchor":"D","level":1,"prior_prefix":"C","next_prefix":"E"},"4":{"id":308076,"text":"The Board may promulgate such regulations relating to the storage, handling, and distribution of prescription drugs by wholesale distributors as it deems necessary to implement this section, to prevent diversion of prescription drugs, and to protect the public.","type":"section","prefixes":["E"],"prefix":"E","entire_prefix":"E","prefix_anchor":"E","level":1,"prior_prefix":"D","next_prefix":"F"},"5":{"id":308077,"text":"Every wholesale distributor shall comply with federal requirements for an electronic, interoperable system to identify, trace, and verify prescription drugs as they are distributed.","type":"section","prefixes":["F"],"prefix":"F","entire_prefix":"F","prefix_anchor":"F","level":1,"prior_prefix":"E"}},"ancestry":[{"id":13241,"edition_id":1,"name":"Wholesale Distributors and Medical Equipment Suppliers","identifier":"3","label":"article","depth":4,"order_by":1,"parent_id":13240,"metadata":{},"date_created":"2026-06-26 03:44:30","date_modified":"2026-06-26 03:44:30","permalink":{"id":243495,"object_type":"structure","relational_id":13241,"identifier":"3","token":"54.1\/III\/34\/3","url":"\/54.1\/III\/34\/3\/","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":86023,"structure_id":13241,"section_number":"54.1-3435","catch_line":"License to act as wholesale distributor; renewal; fee","url":"\/54.1-3435\/","token":"54.1\/III\/34\/3\/54.1-3435","metadata":false},{"id":87353,"structure_id":13241,"section_number":"54.1-3435.01","catch_line":"Registration of nonresident wholesale distributors; renewal; fee","url":"\/54.1-3435.01\/","token":"54.1\/III\/34\/3\/54.1-3435.01","metadata":false},{"id":84340,"structure_id":13241,"section_number":"54.1-3435.02","catch_line":"Certain permitted pharmacies and medical equipment suppliers exempted","url":"\/54.1-3435.02\/","token":"54.1\/III\/34\/3\/54.1-3435.02","metadata":false},{"id":78139,"structure_id":13241,"section_number":"54.1-3435.1","catch_line":"Denial, revocation, and suspension of license, permit, or registration of certain entities","url":"\/54.1-3435.1\/","token":"54.1\/III\/34\/3\/54.1-3435.1","metadata":false},{"id":69203,"structure_id":13241,"section_number":"54.1-3435.2","catch_line":"Permit to act as medical equipment supplier; storage; limitation; regulations","url":"\/54.1-3435.2\/","token":"54.1\/III\/34\/3\/54.1-3435.2","metadata":false},{"id":69720,"structure_id":13241,"section_number":"54.1-3435.3","catch_line":"Inspection and audit","url":"\/54.1-3435.3\/","token":"54.1\/III\/34\/3\/54.1-3435.3","metadata":false},{"id":58671,"structure_id":13241,"section_number":"54.1-3435.3:1","catch_line":"Registration of nonresident medical equipment suppliers; renewal; fee","url":"\/54.1-3435.3_1\/","token":"54.1\/III\/34\/3\/54.1-3435.3_1","metadata":false},{"id":78752,"structure_id":13241,"section_number":"54.1-3435.4","catch_line":"Permit to act as warehouser; regulations","url":"\/54.1-3435.4\/","token":"54.1\/III\/34\/3\/54.1-3435.4","metadata":false},{"id":76533,"structure_id":13241,"section_number":"54.1-3435.4:01","catch_line":"Registration to act as a nonresident warehouser; regulations","url":"\/54.1-3435.4_01\/","token":"54.1\/III\/34\/3\/54.1-3435.4_01","metadata":false},{"id":66466,"structure_id":13241,"section_number":"54.1-3435.4:1","catch_line":"Permitting of third-party logistics provider; renewal","url":"\/54.1-3435.4_1\/","token":"54.1\/III\/34\/3\/54.1-3435.4_1","metadata":false},{"id":56810,"structure_id":13241,"section_number":"54.1-3435.4:2","catch_line":"Registration of nonresident third-party logistics provider; renewal","url":"\/54.1-3435.4_2\/","token":"54.1\/III\/34\/3\/54.1-3435.4_2","metadata":false},{"id":54243,"structure_id":13241,"section_number":"54.1-3435.5","catch_line":"Repealed","url":"\/54.1-3435.5\/","token":"54.1\/III\/34\/3\/54.1-3435.5","metadata":false},{"id":73025,"structure_id":13241,"section_number":"54.1-3436","catch_line":"Repealed","url":"\/54.1-3436\/","token":"54.1\/III\/34\/3\/54.1-3436","metadata":false},{"id":81429,"structure_id":13241,"section_number":"54.1-3436.1","catch_line":"Prescription drug price transparency","url":"\/54.1-3436.1\/","token":"54.1\/III\/34\/3\/54.1-3436.1","metadata":false}],"next_section":{"id":87353,"structure_id":13241,"section_number":"54.1-3435.01","catch_line":"Registration of nonresident wholesale distributors; renewal; fee","url":"\/54.1-3435.01\/","token":"54.1\/III\/34\/3\/54.1-3435.01","metadata":false},"metadata":false,"official_url":"https:\/\/law.lis.virginia.gov\/vacode\/54.1-3435\/","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 7 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 1976, chapter 614; in 1980, chapter 288; in 1988, chapter 765; in 1992, chapter 737; in 2008, chapter <a href=\"https:\/\/legacylis.virginia.gov\/cgi-bin\/legp604.exe?081+ful+CHAP0320\">320<\/a>; in 2015, chapter <a href=\"https:\/\/legacylis.virginia.gov\/cgi-bin\/legp604.exe?151+ful+CHAP0299\">299<\/a>; in 2016, chapter <a href=\"https:\/\/legacylis.virginia.gov\/cgi-bin\/legp604.exe?161+ful+CHAP0221\">221<\/a>.<\/p>","references":false,"refers_to":[{"id":59669,"section_number":"54.1-3401","catch_line":"Definitions","order_by":null,"url":"\/54.1-3401\/"}],"permalink":{"id":243497,"object_type":"law","relational_id":86023,"identifier":"54.1-3435","token":"54.1\/III\/34\/3\/54.1-3435","url":"\/54.1-3435\/","edition_id":1,"permalink":0,"preferred":1},"url":"\/54.1-3435\/","token":"54.1\/III\/34\/3\/54.1-3435","dublin_core":{"Title":"License to act as wholesale distributor; renewal; fee","Type":"Text","Format":"text\/html","Identifier":"\u00a7 54.1-3435","Relation":"Code of Virginia"},"html":"\n\t\t\t\t\t\t<section id=\"A\"><p><span class=\"prefix-number\">A.<\/span> It shall be unlawful for any <span class=\"dictionary\">person<\/span> to engage in the <span class=\"dictionary\">wholesale distribution<\/span> of <span class=\"dictionary\">prescription drugs<\/span> in the Commonwealth without a valid unrevoked license issued by the <span class=\"dictionary\">Board<\/span>. The applicant for licensure as a <span class=\"dictionary\">wholesale distributor<\/span>, as defined in &#xA7; <a class=\"law\" title=\"Definitions\" href=\"\/54.1-3401\/\">54.1-3401<\/a>, in the Commonwealth shall apply to the <span class=\"dictionary\">Board<\/span> for a license, using such forms as the <span class=\"dictionary\">Board<\/span> may furnish; renew such license using such forms as the <span class=\"dictionary\">Board<\/span> may furnish, if granted, annually on a date determined by the <span class=\"dictionary\">Board<\/span> in regulation; notify the <span class=\"dictionary\">Board<\/span> within 30 days of any substantive change in the information reported on the application form previously submitted to the <span class=\"dictionary\">Board<\/span>; and remit a fee as determined by the <span class=\"dictionary\">Board<\/span>. <a id=\"paragraph-308072\" class=\"section-permalink\" href=\"https:\/\/vacode.org\/54.1-3435\/#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> A <span class=\"dictionary\">wholesale distributor<\/span> that ceases distribution of Schedule II through V drugs to a pharmacy, licensed physician <span class=\"dictionary\">dispenser<\/span>, or licensed physician <span class=\"dictionary\">dispensing<\/span> facility located in the Commonwealth due to suspicious <span class=\"dictionary\">orders<\/span> of <span class=\"dictionary\">controlled substances<\/span> shall notify the <span class=\"dictionary\">Board<\/span> within five days of the cessation. For the purposes of this section, &#8220;suspicious <span class=\"dictionary\">orders<\/span> of <span class=\"dictionary\">controlled substances<\/span>&#8221; means, relative to the pharmacy&#8217;s, licensed physician <span class=\"dictionary\">dispenser<\/span>&#8217;s, or licensed physician <span class=\"dictionary\">dispensing<\/span> facility&#8217;s <span class=\"dictionary\">order<\/span> history and the <span class=\"dictionary\">order<\/span> history of similarly situated pharmacies, licensed physician <span class=\"dictionary\">dispensers<\/span>, or licensed physician <span class=\"dictionary\">dispensing<\/span> facilities, (i) <span class=\"dictionary\">orders<\/span> of unusual size, (ii) <span class=\"dictionary\">orders<\/span> deviating substantially from a normal pattern, and (iii) <span class=\"dictionary\">orders<\/span> of unusual frequency. <a id=\"paragraph-308073\" class=\"section-permalink\" href=\"https:\/\/vacode.org\/54.1-3435\/#B\"><i class=\"fa fa-link\"><\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t<section id=\"C\"><p><span class=\"prefix-number\">C.<\/span> A <span class=\"dictionary\">wholesale distributor<\/span> shall be immune from civil liability for giving notice in accordance with subsection B unless the notice was given in bad faith or with <span class=\"dictionary\">malicious<\/span> <span class=\"dictionary\">intent<\/span>. <a id=\"paragraph-308074\" class=\"section-permalink\" href=\"https:\/\/vacode.org\/54.1-3435\/#C\"><i class=\"fa fa-link\"><\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t<section id=\"D\"><p><span class=\"prefix-number\">D.<\/span> The <span class=\"dictionary\">Board<\/span> shall not impose any disciplinary or enforcement action against any licensee or permit holder solely on the basis of a notice received from a <span class=\"dictionary\">wholesale distributor<\/span> pursuant to subsection B. <a id=\"paragraph-308075\" class=\"section-permalink\" href=\"https:\/\/vacode.org\/54.1-3435\/#D\"><i class=\"fa fa-link\"><\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t<section id=\"E\"><p><span class=\"prefix-number\">E.<\/span> The <span class=\"dictionary\">Board<\/span> may promulgate such regulations relating to the storage, handling, and distribution of <span class=\"dictionary\">prescription drugs<\/span> by <span class=\"dictionary\">wholesale distributors<\/span> as it deems necessary to implement this section, to prevent <span class=\"dictionary\">diversion<\/span> of <span class=\"dictionary\">prescription drugs<\/span>, and to protect the public. <a id=\"paragraph-308076\" class=\"section-permalink\" href=\"https:\/\/vacode.org\/54.1-3435\/#E\"><i class=\"fa fa-link\"><\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t<section id=\"F\"><p><span class=\"prefix-number\">F.<\/span> Every <span class=\"dictionary\">wholesale distributor<\/span> shall comply with federal requirements for an electronic, interoperable system to identify, trace, and verify <span class=\"dictionary\">prescription drugs<\/span> as they are distributed. <a id=\"paragraph-308077\" class=\"section-permalink\" href=\"https:\/\/vacode.org\/54.1-3435\/#F\"><i class=\"fa fa-link\"><\/i><\/a><\/p><\/section>","plain_text":"                                 CODE OF VIRGINIA\n\nLICENSE TO ACT AS WHOLESALE DISTRIBUTOR; RENEWAL; FEE (\u00a7 54.1-3435)\n\nA. It shall be unlawful for any person to engage in the wholesale distribution\nof prescription drugs in the Commonwealth without a valid unrevoked license\nissued by the Board. The applicant for licensure as a wholesale distributor, as\ndefined in &#xA7; 54.1-3401, in the Commonwealth shall apply to the Board for a\nlicense, using such forms as the Board may furnish; renew such license using\nsuch forms as the Board may furnish, if granted, annually on a date determined\nby the Board in regulation; notify the Board within 30 days of any substantive\nchange in the information reported on the application form previously submitted\nto the Board; and remit a fee as determined by the Board.\n\nB. A wholesale distributor that ceases distribution of Schedule II through V\ndrugs to a pharmacy, licensed physician dispenser, or licensed physician\ndispensing facility located in the Commonwealth due to suspicious orders of\ncontrolled substances shall notify the Board within five days of the cessation.\nFor the purposes of this section, &#8220;suspicious orders of controlled\nsubstances&#8221; means, relative to the pharmacy&#8217;s, licensed physician\ndispenser&#8217;s, or licensed physician dispensing facility&#8217;s order\nhistory and the order history of similarly situated pharmacies, licensed\nphysician dispensers, or licensed physician dispensing facilities, (i) orders of\nunusual size, (ii) orders deviating substantially from a normal pattern, and\n(iii) orders of unusual frequency.\n\nC. A wholesale distributor shall be immune from civil liability for giving\nnotice in accordance with subsection B unless the notice was given in bad faith\nor with malicious intent.\n\nD. The Board shall not impose any disciplinary or enforcement action against any\nlicensee or permit holder solely on the basis of a notice received from a\nwholesale distributor pursuant to subsection B.\n\nE. The Board may promulgate such regulations relating to the storage, handling,\nand distribution of prescription drugs by wholesale distributors as it deems\nnecessary to implement this section, to prevent diversion of prescription drugs,\nand to protect the public.\n\nF. Every wholesale distributor shall comply with federal requirements for an\nelectronic, interoperable system to identify, trace, and verify prescription\ndrugs as they are distributed.\n\nHISTORY: 1970, c. 650, \u00a7 54-524.44; 1976, c. 614; 1980, c. 288; 1988, c. 765;\n1992, c. 737; 2008, c. 320; 2015, c. 299; 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}}