{"formats":[{"name":"JSON","format":"json","url":"\/downloads\/2025\/code-json\/54.1-3408.04.json"},{"name":"Plain Text","format":"text","url":"\/downloads\/2025\/code-text\/54.1-3408.04.txt"},{"name":"XML","format":"xml","url":"\/downloads\/2025\/code-xml\/54.1-3408.04.xml"},{"name":"HTML","format":"html","url":"\/downloads\/2025\/code-html\/54.1-3408.04.html"}],"law_id":61115,"edition_id":1,"section_id":61115,"structure_id":13871,"section_number":"54.1-3408.04","catch_line":"Dispensing of interchangeable biosimilars permitted","history":"2013, cc. 412, 544.","full_text":"A\n\nA pharmacist may dispense a biosimilar that has been licensed by the U.S. Food and Drug Administration as interchangeable with the prescribed product unless (i) the prescriber indicates such substitute is not authorized by specifying on the prescription “brand medically necessary” or (ii) the patient insists on the dispensing of the prescribed biological product. In the case of an oral prescription, the prescriber’s oral dispensing instructions regarding dispensing of an interchangeable biosimilar shall be followed. No pharmacist shall dispense a biosimilar in place of a prescribed biological product unless the biosimilar has been licensed as interchangeable with the prescribed biological product by the U.S. Food and Drug Administration.B\n\nWhen a pharmacist dispenses an interchangeable biosimilar in the place of a prescribed biological product, the pharmacist or his designee shall inform the patient prior to dispensing the interchangeable biosimilar. The pharmacist or his designee shall also indicate, unless otherwise directed by the prescriber, on both the record of dispensing and the prescription label, the brand name or, in the case of an interchangeable biosimilar, the product name and the name of the manufacturer or distributor of the interchangeable biosimilar. Whenever a pharmacist substitutes an interchangeable biosimilar pursuant to a prescription written for a brand-name product, the pharmacist or his designee shall label the drug with the name of the interchangeable biosimilar followed by the words “Substituted for” and the name of the biological product for which the prescription was written. Records of substitutions of interchangeable biosimilars shall be maintained by the pharmacist and the prescriber for a period of not less than two years from the date of dispensing.C\n\n[Expired]D\n\n[Expired]","order_by":null,"text":{"0":{"id":223419,"text":"A pharmacist may dispense a biosimilar that has been licensed by the U.S. Food and Drug Administration as interchangeable with the prescribed product unless (i) the prescriber indicates such substitute is not authorized by specifying on the prescription “brand medically necessary” or (ii) the patient insists on the dispensing of the prescribed biological product. In the case of an oral prescription, the prescriber’s oral dispensing instructions regarding dispensing of an interchangeable biosimilar shall be followed. No pharmacist shall dispense a biosimilar in place of a prescribed biological product unless the biosimilar has been licensed as interchangeable with the prescribed biological product by the U.S. Food and Drug Administration.","type":"section","prefixes":["A"],"prefix":"A","entire_prefix":"A","prefix_anchor":"A","level":1,"next_prefix":"B"},"1":{"id":223420,"text":"When a pharmacist dispenses an interchangeable biosimilar in the place of a prescribed biological product, the pharmacist or his designee shall inform the patient prior to dispensing the interchangeable biosimilar. The pharmacist or his designee shall also indicate, unless otherwise directed by the prescriber, on both the record of dispensing and the prescription label, the brand name or, in the case of an interchangeable biosimilar, the product name and the name of the manufacturer or distributor of the interchangeable biosimilar. Whenever a pharmacist substitutes an interchangeable biosimilar pursuant to a prescription written for a brand-name product, the pharmacist or his designee shall label the drug with the name of the interchangeable biosimilar followed by the words “Substituted for” and the name of the biological product for which the prescription was written. Records of substitutions of interchangeable biosimilars shall be maintained by the pharmacist and the prescriber for a period of not less than two years from the date of dispensing.","type":"section","prefixes":["B"],"prefix":"B","entire_prefix":"B","prefix_anchor":"B","level":1,"prior_prefix":"A","next_prefix":"C"},"2":{"id":223421,"text":"[Expired]","type":"section","prefixes":["C"],"prefix":"C","entire_prefix":"C","prefix_anchor":"C","level":1,"prior_prefix":"B","next_prefix":"D"},"3":{"id":223422,"text":"[Expired]","type":"section","prefixes":["D"],"prefix":"D","entire_prefix":"D","prefix_anchor":"D","level":1,"prior_prefix":"C"}},"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; 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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":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},"next_section":{"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},"metadata":false,"official_url":"https:\/\/law.lis.virginia.gov\/vacode\/54.1-3408.04\/","history_text":"

This law was first created in 2013. The record of its establishment is cataloged in chapters 412<\/a> and 544<\/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":[{"id":77369,"section_number":"54.1-3434.1","catch_line":"Nonresident pharmacies to register with Board","order_by":null,"url":"\/54.1-3434.1\/"},{"id":83286,"section_number":"54.1-3457","catch_line":"Prohibited acts","order_by":null,"url":"\/54.1-3457\/"}],"refers_to":false,"permalink":{"id":243279,"object_type":"law","relational_id":61115,"identifier":"54.1-3408.04","token":"54.1\/III\/34\/1\/54.1-3408.04","url":"\/54.1-3408.04\/","edition_id":1,"permalink":0,"preferred":1},"url":"\/54.1-3408.04\/","token":"54.1\/III\/34\/1\/54.1-3408.04","dublin_core":{"Title":"Dispensing of interchangeable biosimilars permitted","Type":"Text","Format":"text\/html","Identifier":"\u00a7 54.1-3408.04","Relation":"Code of Virginia"},"html":"\n\t\t\t\t\t\t

A.<\/span> A pharmacist may dispense<\/span> a biosimilar<\/span> that has been licensed by the U.S. Food and Drug<\/span> Administration as interchangeable<\/span> with the prescribed product unless (i) the prescriber<\/span> indicates such substitute is not authorized by specifying on the prescription<\/span> “brand medically necessary” or (ii) the patient insists on the dispensing<\/span> of the prescribed biological product<\/span>. In the case of an oral prescription<\/span>, the prescriber<\/span>’s oral dispensing<\/span> instructions regarding dispensing<\/span> of an interchangeable<\/span> biosimilar<\/span> shall be followed. No pharmacist shall dispense<\/span> a biosimilar<\/span> in place of a prescribed biological product<\/span> unless the biosimilar<\/span> has been licensed as interchangeable<\/span> with the prescribed biological product<\/span> by the U.S. Food and Drug<\/span> Administration. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

B.<\/span> When a pharmacist dispenses<\/span> an interchangeable<\/span> biosimilar<\/span> in the place of a prescribed biological product<\/span>, the pharmacist or his designee shall inform the patient prior to dispensing<\/span> the interchangeable<\/span> biosimilar<\/span>. The pharmacist or his designee shall also indicate, unless otherwise directed by the prescriber<\/span>, on both the record of dispensing<\/span> and the prescription<\/span> label<\/span>, the brand name or, in the case of an interchangeable<\/span> biosimilar<\/span>, the product name and the name of the manufacturer<\/span> or distributor<\/span> of the interchangeable<\/span> biosimilar<\/span>. Whenever a pharmacist substitutes an interchangeable<\/span> biosimilar<\/span> pursuant to a prescription<\/span> written for a brand-name product, the pharmacist or his designee shall label<\/span> the drug<\/span> with the name of the interchangeable<\/span> biosimilar<\/span> followed by the words “Substituted for” and the name of the biological product<\/span> for which the prescription<\/span> was written. Records of substitutions of interchangeable<\/span> biosimilars<\/span> shall be maintained by the pharmacist and the prescriber<\/span> for a period of not less than two years from the date of dispensing<\/span>. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

C.<\/span> [Expired] <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

D.<\/span> [Expired] <\/i><\/a><\/p><\/section>","plain_text":" CODE OF VIRGINIA\n\nDISPENSING OF INTERCHANGEABLE BIOSIMILARS PERMITTED (\u00a7 54.1-3408.04)\n\nA. A pharmacist may dispense a biosimilar that has been licensed by the U.S.\nFood and Drug Administration as interchangeable with the prescribed product\nunless (i) the prescriber indicates such substitute is not authorized by\nspecifying on the prescription “brand medically necessary” or (ii)\nthe patient insists on the dispensing of the prescribed biological product. In\nthe case of an oral prescription, the prescriber’s oral dispensing\ninstructions regarding dispensing of an interchangeable biosimilar shall be\nfollowed. No pharmacist shall dispense a biosimilar in place of a prescribed\nbiological product unless the biosimilar has been licensed as interchangeable\nwith the prescribed biological product by the U.S. Food and Drug Administration.\n\nB. When a pharmacist dispenses an interchangeable biosimilar in the place of a\nprescribed biological product, the pharmacist or his designee shall inform the\npatient prior to dispensing the interchangeable biosimilar. The pharmacist or\nhis designee shall also indicate, unless otherwise directed by the prescriber,\non both the record of dispensing and the prescription label, the brand name or,\nin the case of an interchangeable biosimilar, the product name and the name of\nthe manufacturer or distributor of the interchangeable biosimilar. Whenever a\npharmacist substitutes an interchangeable biosimilar pursuant to a prescription\nwritten for a brand-name product, the pharmacist or his designee shall label the\ndrug with the name of the interchangeable biosimilar followed by the words\n“Substituted for” and the name of the biological product for which\nthe prescription was written. Records of substitutions of interchangeable\nbiosimilars shall be maintained by the pharmacist and the prescriber for a\nperiod of not less than two years from the date of dispensing.\n\nC. [Expired]\n\nD. [Expired]\n\nHISTORY: 2013, cc. 412, 544.","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}}