{"formats":[{"name":"JSON","format":"json","url":"\/downloads\/2025\/code-json\/54.1-3435.01.json"},{"name":"Plain Text","format":"text","url":"\/downloads\/2025\/code-text\/54.1-3435.01.txt"},{"name":"XML","format":"xml","url":"\/downloads\/2025\/code-xml\/54.1-3435.01.xml"},{"name":"HTML","format":"html","url":"\/downloads\/2025\/code-html\/54.1-3435.01.html"}],"law_id":87353,"edition_id":1,"section_id":87353,"structure_id":13241,"section_number":"54.1-3435.01","catch_line":"Registration of nonresident wholesale distributors; renewal; fee","history":"1994, c. 300; 2008, c. 320; 2015, c. 299; 2016, c. 221.","full_text":"A\n\nAny person located outside the Commonwealth who engages in the wholesale distribution of prescription drugs into the Commonwealth shall be registered with the Board. The applicant for registration as a nonresident wholesale distributor shall apply to the Board using such forms as the Board may furnish; renew such registration, if granted, using such forms as the Board may furnish, annually on a date determined by the Board in regulation; notify the Board within 30 days of any substantive change in the information previously submitted to the Board; and remit a fee, which shall be the fee specified for wholesale distributors located within the Commonwealth.B\n\nThe nonresident wholesale distributor shall at all times maintain a valid, unexpired license, permit, or registration in the state in which it is located 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 distributions into other jurisdictions and shall be provided to the Board, its authorized agent, or any agent designated by the Superintendent of State Police upon request within seven days of receipt of such request.D\n\nA nonresident 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, “suspicious orders of controlled substances” means, relative to the pharmacy’s, licensed physician dispenser’s, or licensed physician dispensing facility’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.E\n\nA nonresident wholesale distributor shall be immune from civil liability for giving notice in accordance with subsection D unless the notice was given in bad faith or with malicious intent.F\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 nonresident wholesale distributor pursuant to subsection D.G\n\nThis section shall not apply to persons who distribute prescription drugs directly to a licensed wholesale distributor located within the Commonwealth.H\n\nEvery nonresident 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":312802,"text":"Any person located outside the Commonwealth who engages in the wholesale distribution of prescription drugs into the Commonwealth shall be registered with the Board. The applicant for registration as a nonresident wholesale distributor shall apply to the Board using such forms as the Board may furnish; renew such registration, if granted, using such forms as the Board may furnish, annually on a date determined by the Board in regulation; notify the Board within 30 days of any substantive change in the information previously submitted to the Board; and remit a fee, which shall be the fee specified for wholesale distributors located within the Commonwealth.","type":"section","prefixes":["A"],"prefix":"A","entire_prefix":"A","prefix_anchor":"A","level":1,"next_prefix":"B"},"1":{"id":312803,"text":"The nonresident wholesale distributor shall at all times maintain a valid, unexpired license, permit, or registration in the state in which it is located 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":312804,"text":"Records of prescription drugs distributed into the Commonwealth shall be maintained in such a manner that they are readily retrievable from records of distributions into other jurisdictions and shall be provided to the Board, its authorized agent, or any agent designated by the Superintendent 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","next_prefix":"D"},"3":{"id":312805,"text":"A nonresident 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, “suspicious orders of controlled substances” means, relative to the pharmacy’s, licensed physician dispenser’s, or licensed physician dispensing facility’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":["D"],"prefix":"D","entire_prefix":"D","prefix_anchor":"D","level":1,"prior_prefix":"C","next_prefix":"E"},"4":{"id":312806,"text":"A nonresident wholesale distributor shall be immune from civil liability for giving notice in accordance with subsection D unless the notice was given in bad faith or with malicious intent.","type":"section","prefixes":["E"],"prefix":"E","entire_prefix":"E","prefix_anchor":"E","level":1,"prior_prefix":"D","next_prefix":"F"},"5":{"id":312807,"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 nonresident wholesale distributor pursuant to subsection D.","type":"section","prefixes":["F"],"prefix":"F","entire_prefix":"F","prefix_anchor":"F","level":1,"prior_prefix":"E","next_prefix":"G"},"6":{"id":312808,"text":"This section shall not apply to persons who distribute prescription drugs directly to a licensed wholesale distributor located within the Commonwealth.","type":"section","prefixes":["G"],"prefix":"G","entire_prefix":"G","prefix_anchor":"G","level":1,"prior_prefix":"F","next_prefix":"H"},"7":{"id":312809,"text":"Every nonresident 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":["H"],"prefix":"H","entire_prefix":"H","prefix_anchor":"H","level":1,"prior_prefix":"G"}},"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}],"previous_section":{"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},"next_section":{"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},"metadata":false,"official_url":"https:\/\/law.lis.virginia.gov\/vacode\/54.1-3435.01\/","history_text":"

This law was first created in 1994. 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. It has been modified 3 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 2008, chapter 320<\/a>; in 2015, chapter 299<\/a>; in 2016, chapter 221<\/a>.<\/p>","references":false,"refers_to":false,"permalink":{"id":243501,"object_type":"law","relational_id":87353,"identifier":"54.1-3435.01","token":"54.1\/III\/34\/3\/54.1-3435.01","url":"\/54.1-3435.01\/","edition_id":1,"permalink":0,"preferred":1},"url":"\/54.1-3435.01\/","token":"54.1\/III\/34\/3\/54.1-3435.01","dublin_core":{"Title":"Registration of nonresident wholesale distributors; renewal; fee","Type":"Text","Format":"text\/html","Identifier":"\u00a7 54.1-3435.01","Relation":"Code of Virginia"},"html":"\n\t\t\t\t\t\t

A.<\/span> Any person<\/span> located outside the Commonwealth who engages in the wholesale distribution<\/span> of prescription drugs<\/span> into the Commonwealth shall be registered with the Board<\/span>. The applicant for registration as a nonresident wholesale distributor<\/span> shall apply to the Board<\/span> using such forms as the Board<\/span> may furnish; renew such registration, if granted, using such forms as the Board<\/span> may furnish, annually on a date determined by the Board<\/span> in regulation; notify the Board<\/span> within 30 days of any substantive change in the information previously submitted to the Board<\/span>; and remit a fee, which shall be the fee specified for wholesale distributors<\/span> located within the Commonwealth. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

B.<\/span> The nonresident wholesale distributor<\/span> shall at all times maintain a valid, unexpired license, permit, or registration in the state in which it is located 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 distributions 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 State Police upon request within seven days of receipt of such request. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

D.<\/span> A nonresident wholesale distributor<\/span> that ceases distribution of Schedule II through V drugs to a pharmacy, licensed physician dispenser<\/span>, or licensed physician dispensing<\/span> facility located in the Commonwealth due to suspicious orders<\/span> of controlled substances<\/span> shall notify the Board<\/span> within five days of the cessation. For the purposes of this section, “suspicious orders<\/span> of controlled substances<\/span>” means, relative to the pharmacy’s, licensed physician dispenser<\/span>’s, or licensed physician dispensing<\/span> facility’s order<\/span> history and the order<\/span> history of similarly situated pharmacies, licensed physician dispensers<\/span>, or licensed physician dispensing<\/span> facilities, (i) orders<\/span> of unusual size, (ii) orders<\/span> deviating substantially from a normal pattern, and (iii) orders<\/span> of unusual frequency. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

E.<\/span> A nonresident wholesale distributor<\/span> shall be immune from civil liability for giving notice in accordance with subsection D unless the notice was given in bad faith or with malicious<\/span> intent<\/span>. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

F.<\/span> The 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 nonresident wholesale distributor<\/span> pursuant to subsection D. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

G.<\/span> This section shall not apply to persons<\/span> who distribute<\/span> prescription drugs<\/span> directly to a licensed wholesale distributor<\/span> located within the Commonwealth. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

H.<\/span> Every nonresident wholesale distributor<\/span> shall comply with federal requirements for an electronic, interoperable system to identify, trace, and verify prescription drugs<\/span> as they are distributed. <\/i><\/a><\/p><\/section>","plain_text":" CODE OF VIRGINIA\n\nREGISTRATION OF NONRESIDENT WHOLESALE DISTRIBUTORS; RENEWAL; FEE (\u00a7\n54.1-3435.01)\n\nA. Any person located outside the Commonwealth who engages in the wholesale\ndistribution of prescription drugs into the Commonwealth shall be registered\nwith the Board. The applicant for registration as a nonresident wholesale\ndistributor shall apply to the Board using such forms as the Board may furnish;\nrenew such registration, if granted, using such forms as the Board may furnish,\nannually on a date determined by the Board in regulation; notify the Board\nwithin 30 days of any substantive change in the information previously submitted\nto the Board; and remit a fee, which shall be the fee specified for wholesale\ndistributors located within the Commonwealth.\n\nB. The nonresident wholesale distributor shall at all times maintain a valid,\nunexpired license, permit, or registration in the state in which it is located\nand shall furnish proof of such upon application and at each renewal.\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\ndistributions into other jurisdictions and shall be provided to the Board, its\nauthorized agent, or any agent designated by the Superintendent of State Police\nupon request within seven days of receipt of such request.\n\nD. A nonresident wholesale distributor that ceases distribution of Schedule II\nthrough V drugs to a pharmacy, licensed physician dispenser, or licensed\nphysician dispensing facility located in the Commonwealth due to suspicious\norders of controlled substances shall notify the Board within five days of the\ncessation. For the purposes of this section, “suspicious orders of\ncontrolled substances” means, relative to the pharmacy’s, licensed\nphysician dispenser’s, or licensed physician dispensing facility’s\norder history 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\nE. A nonresident wholesale distributor shall be immune from civil liability for\ngiving notice in accordance with subsection D unless the notice was given in bad\nfaith or with malicious intent.\n\nF. 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\nnonresident wholesale distributor pursuant to subsection D.\n\nG. This section shall not apply to persons who distribute prescription drugs\ndirectly to a licensed wholesale distributor located within the Commonwealth.\n\nH. Every nonresident wholesale distributor shall comply with federal\nrequirements for an electronic, interoperable system to identify, trace, and\nverify prescription drugs as they are distributed.\n\nHISTORY: 1994, c. 300; 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}}