{"formats":[{"name":"JSON","format":"json","url":"\/downloads\/2025\/code-json\/54.1-3423.json"},{"name":"Plain Text","format":"text","url":"\/downloads\/2025\/code-text\/54.1-3423.txt"},{"name":"XML","format":"xml","url":"\/downloads\/2025\/code-xml\/54.1-3423.xml"},{"name":"HTML","format":"html","url":"\/downloads\/2025\/code-html\/54.1-3423.html"}],"law_id":87135,"edition_id":1,"section_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","history":"1972, c. 798, \u00a7 54-524.47:3; 1978, c. 833; 1980, c. 288; 1988, c. 765; 1996, cc. 468, 496; 1998, c. 490; 2009, cc. 149, 169; 2010, c. 28; 2014, c. 148; 2017, cc. 58, 110; 2018, c. 774; 2020, c. 941; 2023, cc. 744, 794; 2024, cc. 63, 513; 2025, cc. 278, 283.","full_text":"A\n\nThe Board shall register an applicant to manufacture or distribute controlled substances included in Schedules I through V unless it determines that the issuance of that registration would be inconsistent with the public interest. In determining the public interest, the Board shall consider the following factors:1\n\nMaintenance of effective controls against diversion of controlled substances into other than legitimate medical, scientific, or industrial channels;2\n\nCompliance with applicable state and local law;3\n\nAny convictions of the applicant under any federal and state laws relating to any controlled substance;4\n\nPast experience in the manufacture or distribution of controlled substances, and the existence in the applicant’s establishment of effective controls against diversion;5\n\nFurnishing by the applicant of false or fraudulent material in any application filed under this chapter;6\n\nSuspension or revocation of the applicant’s federal registration to manufacture, distribute, or dispense controlled substances as authorized by federal law; and7\n\nAny other factors relevant to and consistent with the public health and safety.B\n\nRegistration under subsection A does not entitle a registrant to manufacture and distribute controlled substances in Schedule I or II other than those specified in the registration.C\n\nPractitioners must be registered to conduct research or laboratory analysis with controlled substances in Schedules II through VI or marijuana. Practitioners registered under federal law to conduct research with Schedule I substances, other than marijuana, may conduct research with Schedule I controlled substances within the Commonwealth upon furnishing the evidence of that federal registration.D\n\nThe Board may register other persons or entities to possess controlled substances listed on Schedules II through VI upon a determination that (i) there is a documented need, (ii) the issuance of the registration is consistent with the public interest, (iii) the possession and subsequent use of the controlled substances complies with applicable state and federal laws and regulations, and (iv) the subsequent storage, use, and recordkeeping of the controlled substances will be under the general supervision of a licensed pharmacist, practitioner of medicine, osteopathy, podiatry, dentistry, or veterinary medicine as specified in the Board’s regulations. The Board shall consider, at a minimum, the factors listed in subsection A in determining whether the registration shall be issued. Notwithstanding the exceptions listed in subsection A of § 54.1-3422, the Board may mandate a controlled substances registration for sites maintaining certain types and quantities of Schedules II through VI controlled substances as it may specify in its regulations. The Board shall promulgate regulations related to requirements or criteria for the issuance of such controlled substances registration, storage, security, supervision, and recordkeeping. Notwithstanding the provisions of this subsection or Board regulations, the Board may register a correctional facility to maintain a floor stock of long-acting injectable or extended-release prescription drugs for the treatment of mental illness or substance use disorder. Such long-acting injectable or extended-release prescription drugs shall be stored in an area accessible only to persons who are licensed to administer such prescription drugs, regardless of whether the prescriber is on site. Each correctional facility shall maintain an ongoing perpetual inventory of all such drugs in Schedules II through V. Such perpetual inventory shall (a) accurately indicate the physical count of each drug on hand at the time the inventory is performed and (b) no less than once per month, include a reconciliation of each drug with a written explanation for any difference between the physical count and the theoretical count.E\n\nThe Board may register a public or private animal shelter as defined in § 3.2-6500 to purchase, possess, and administer certain Schedules II through VI controlled substances approved by the State Veterinarian for the purpose of euthanizing injured, sick, homeless, and unwanted domestic pets and animals and to purchase, possess, and administer certain Schedule VI drugs and biological products for the purpose of preventing, controlling, and treating certain communicable diseases that failure to control would result in transmission to the animal population in the shelter. Controlled substances used for euthanasia shall be administered only in accordance with protocols established by the State Veterinarian and only by persons trained in accordance with instructions by the State Veterinarian. The list of Schedule VI drugs and biological products used for treatment and prevention of communicable diseases within the shelter shall be determined by the supervising veterinarian of the shelter and the drugs and biological products shall be administered only pursuant to written protocols established or approved by the supervising veterinarian of the shelter and only by persons who have been trained in accordance with instructions established or approved by the supervising veterinarian. The shelter shall maintain a copy of the approved list of drugs and biological products, written protocols for administering, and training records of those persons administering drugs and biological products on the premises of the shelter.F\n\nThe Board may register a facility, as defined in § 37.2-100, that provides crisis stabilization services and is licensed by the Department of Behavioral Health and Developmental Services. Such facility may maintain a stock of Schedules II through VI controlled substances necessary for immediate treatment of patients admitted to such facility, which may be accessed and administered by a person licensed to administer drugs pursuant to a written or oral order of a prescriber in the absence of a prescriber.G\n\nThe Board may register an entity at which a patient is treated by the use of instrumentation and diagnostic equipment through which images and medical records may be transmitted electronically for the purpose of establishing a bona fide practitioner-patient relationship and is prescribed Schedules II through VI controlled substances when such prescribing is in compliance with federal requirements for the practice of telemedicine and the patient is not in the physical presence of a practitioner registered with the U.S. Drug Enforcement Administration. In determining whether the registration shall be issued, the Board shall consider (i) the factors listed in subsection A, (ii) whether there is a documented need for such registration, and (iii) whether the issuance of the registration is consistent with the public interest.H\n\nApplications for controlled substances registration certificates and renewals thereof shall be made on a form prescribed by the Board and such applications shall be accompanied by a fee in an amount to be determined by the Board.I\n\nUpon (i) any change in ownership or control of a business, (ii) any change of location of the controlled substances stock, (iii) the termination of authority by or of the person named as the responsible party on a controlled substances registration, or (iv) a change in the supervising practitioner, if applicable, the registrant or responsible party shall immediately surrender the registration. The registrant shall, within 14 days following surrender of a registration, file a new application and, if applicable, name the new responsible party or supervising practitioner.","order_by":null,"text":{"0":{"id":312001,"text":"The Board shall register an applicant to manufacture or distribute controlled substances included in Schedules I through V unless it determines that the issuance of that registration would be inconsistent with the public interest. In determining the public interest, the Board shall consider the following factors:","type":"section","prefixes":["A"],"prefix":"A","entire_prefix":"A","prefix_anchor":"A","level":1,"next_prefix":"A1"},"1":{"id":312002,"text":"Maintenance of effective controls against diversion of controlled substances into other than legitimate medical, scientific, or industrial channels;","type":"section","prefixes":["A","1"],"prefix":"1","entire_prefix":"A1","prefix_anchor":"A1","level":2,"prior_prefix":"A","next_prefix":"A2"},"2":{"id":312003,"text":"Compliance with applicable state and local law;","type":"section","prefixes":["A","2"],"prefix":"2","entire_prefix":"A2","prefix_anchor":"A2","level":2,"prior_prefix":"A1","next_prefix":"A3"},"3":{"id":312004,"text":"Any convictions of the applicant under any federal and state laws relating to any controlled substance;","type":"section","prefixes":["A","3"],"prefix":"3","entire_prefix":"A3","prefix_anchor":"A3","level":2,"prior_prefix":"A2","next_prefix":"A4"},"4":{"id":312005,"text":"Past experience in the manufacture or distribution of controlled substances, and the existence in the applicant’s establishment of effective controls against diversion;","type":"section","prefixes":["A","4"],"prefix":"4","entire_prefix":"A4","prefix_anchor":"A4","level":2,"prior_prefix":"A3","next_prefix":"A5"},"5":{"id":312006,"text":"Furnishing by the applicant of false or fraudulent material in any application filed under this chapter;","type":"section","prefixes":["A","5"],"prefix":"5","entire_prefix":"A5","prefix_anchor":"A5","level":2,"prior_prefix":"A4","next_prefix":"A6"},"6":{"id":312007,"text":"Suspension or revocation of the applicant’s federal registration to manufacture, distribute, or dispense controlled substances as authorized by federal law; and","type":"section","prefixes":["A","6"],"prefix":"6","entire_prefix":"A6","prefix_anchor":"A6","level":2,"prior_prefix":"A5","next_prefix":"A7"},"7":{"id":312008,"text":"Any other factors relevant to and consistent with the public health and safety.","type":"section","prefixes":["A","7"],"prefix":"7","entire_prefix":"A7","prefix_anchor":"A7","level":2,"prior_prefix":"A6","next_prefix":"B"},"8":{"id":312009,"text":"Registration under subsection A does not entitle a registrant to manufacture and distribute controlled substances in Schedule I or II other than those specified in the registration.","type":"section","prefixes":["B"],"prefix":"B","entire_prefix":"B","prefix_anchor":"B","level":1,"prior_prefix":"A7","next_prefix":"C"},"9":{"id":312010,"text":"Practitioners must be registered to conduct research or laboratory analysis with controlled substances in Schedules II through VI or marijuana. Practitioners registered under federal law to conduct research with Schedule I substances, other than marijuana, may conduct research with Schedule I controlled substances within the Commonwealth upon furnishing the evidence of that federal registration.","type":"section","prefixes":["C"],"prefix":"C","entire_prefix":"C","prefix_anchor":"C","level":1,"prior_prefix":"B","next_prefix":"D"},"10":{"id":312011,"text":"The Board may register other persons or entities to possess controlled substances listed on Schedules II through VI upon a determination that (i) there is a documented need, (ii) the issuance of the registration is consistent with the public interest, (iii) the possession and subsequent use of the controlled substances complies with applicable state and federal laws and regulations, and (iv) the subsequent storage, use, and recordkeeping of the controlled substances will be under the general supervision of a licensed pharmacist, practitioner of medicine, osteopathy, podiatry, dentistry, or veterinary medicine as specified in the Board’s regulations. The Board shall consider, at a minimum, the factors listed in subsection A in determining whether the registration shall be issued. Notwithstanding the exceptions listed in subsection A of § 54.1-3422, the Board may mandate a controlled substances registration for sites maintaining certain types and quantities of Schedules II through VI controlled substances as it may specify in its regulations. The Board shall promulgate regulations related to requirements or criteria for the issuance of such controlled substances registration, storage, security, supervision, and recordkeeping. Notwithstanding the provisions of this subsection or Board regulations, the Board may register a correctional facility to maintain a floor stock of long-acting injectable or extended-release prescription drugs for the treatment of mental illness or substance use disorder. Such long-acting injectable or extended-release prescription drugs shall be stored in an area accessible only to persons who are licensed to administer such prescription drugs, regardless of whether the prescriber is on site. Each correctional facility shall maintain an ongoing perpetual inventory of all such drugs in Schedules II through V. Such perpetual inventory shall (a) accurately indicate the physical count of each drug on hand at the time the inventory is performed and (b) no less than once per month, include a reconciliation of each drug with a written explanation for any difference between the physical count and the theoretical count.","type":"section","prefixes":["D"],"prefix":"D","entire_prefix":"D","prefix_anchor":"D","level":1,"prior_prefix":"C","next_prefix":"E"},"11":{"id":312012,"text":"The Board may register a public or private animal shelter as defined in § 3.2-6500 to purchase, possess, and administer certain Schedules II through VI controlled substances approved by the State Veterinarian for the purpose of euthanizing injured, sick, homeless, and unwanted domestic pets and animals and to purchase, possess, and administer certain Schedule VI drugs and biological products for the purpose of preventing, controlling, and treating certain communicable diseases that failure to control would result in transmission to the animal population in the shelter. Controlled substances used for euthanasia shall be administered only in accordance with protocols established by the State Veterinarian and only by persons trained in accordance with instructions by the State Veterinarian. The list of Schedule VI drugs and biological products used for treatment and prevention of communicable diseases within the shelter shall be determined by the supervising veterinarian of the shelter and the drugs and biological products shall be administered only pursuant to written protocols established or approved by the supervising veterinarian of the shelter and only by persons who have been trained in accordance with instructions established or approved by the supervising veterinarian. The shelter shall maintain a copy of the approved list of drugs and biological products, written protocols for administering, and training records of those persons administering drugs and biological products on the premises of the shelter.","type":"section","prefixes":["E"],"prefix":"E","entire_prefix":"E","prefix_anchor":"E","level":1,"prior_prefix":"D","next_prefix":"F"},"12":{"id":312013,"text":"The Board may register a facility, as defined in § 37.2-100, that provides crisis stabilization services and is licensed by the Department of Behavioral Health and Developmental Services. Such facility may maintain a stock of Schedules II through VI controlled substances necessary for immediate treatment of patients admitted to such facility, which may be accessed and administered by a person licensed to administer drugs pursuant to a written or oral order of a prescriber in the absence of a prescriber.","type":"section","prefixes":["F"],"prefix":"F","entire_prefix":"F","prefix_anchor":"F","level":1,"prior_prefix":"E","next_prefix":"G"},"13":{"id":312014,"text":"The Board may register an entity at which a patient is treated by the use of instrumentation and diagnostic equipment through which images and medical records may be transmitted electronically for the purpose of establishing a bona fide practitioner-patient relationship and is prescribed Schedules II through VI controlled substances when such prescribing is in compliance with federal requirements for the practice of telemedicine and the patient is not in the physical presence of a practitioner registered with the U.S. Drug Enforcement Administration. In determining whether the registration shall be issued, the Board shall consider (i) the factors listed in subsection A, (ii) whether there is a documented need for such registration, and (iii) whether the issuance of the registration is consistent with the public interest.","type":"section","prefixes":["G"],"prefix":"G","entire_prefix":"G","prefix_anchor":"G","level":1,"prior_prefix":"F","next_prefix":"H"},"14":{"id":312015,"text":"Applications for controlled substances registration certificates and renewals thereof shall be made on a form prescribed by the Board and such applications shall be accompanied by a fee in an amount to be determined by the Board.","type":"section","prefixes":["H"],"prefix":"H","entire_prefix":"H","prefix_anchor":"H","level":1,"prior_prefix":"G","next_prefix":"I"},"15":{"id":312016,"text":"Upon (i) any change in ownership or control of a business, (ii) any change of location of the controlled substances stock, (iii) the termination of authority by or of the person named as the responsible party on a controlled substances registration, or (iv) a change in the supervising practitioner, if applicable, the registrant or responsible party shall immediately surrender the registration. The registrant shall, within 14 days following surrender of a registration, file a new application and, if applicable, name the new responsible party or supervising practitioner.","type":"section","prefixes":["I"],"prefix":"I","entire_prefix":"I","prefix_anchor":"I","level":1,"prior_prefix":"H"}},"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; pharmacists' authority to compound under certain conditions; labeling and record maintenance requirements","url":"\/54.1-3410.2\/","token":"54.1\/III\/34\/1\/54.1-3410.2","metadata":false},{"id":70552,"structure_id":13871,"section_number":"54.1-3410.3","catch_line":"Accessible prescription labels","url":"\/54.1-3410.3\/","token":"54.1\/III\/34\/1\/54.1-3410.3","metadata":false},{"id":77643,"structure_id":13871,"section_number":"54.1-3411","catch_line":"When prescriptions may be refilled","url":"\/54.1-3411\/","token":"54.1\/III\/34\/1\/54.1-3411","metadata":false},{"id":61132,"structure_id":13871,"section_number":"54.1-3411.1","catch_line":"Prohibition on returns, exchanges, or re-dispensing of drugs; exceptions","url":"\/54.1-3411.1\/","token":"54.1\/III\/34\/1\/54.1-3411.1","metadata":false},{"id":65473,"structure_id":13871,"section_number":"54.1-3411.2","catch_line":"Prescription drug disposal programs","url":"\/54.1-3411.2\/","token":"54.1\/III\/34\/1\/54.1-3411.2","metadata":false},{"id":86720,"structure_id":13871,"section_number":"54.1-3411.2:1","catch_line":"Guidelines for disposal of unused drugs","url":"\/54.1-3411.2_1\/","token":"54.1\/III\/34\/1\/54.1-3411.2_1","metadata":false},{"id":79333,"structure_id":13871,"section_number":"54.1-3412","catch_line":"Date of dispensing; initials of pharmacist; automated data processing system","url":"\/54.1-3412\/","token":"54.1\/III\/34\/1\/54.1-3412","metadata":false},{"id":84967,"structure_id":13871,"section_number":"54.1-3413","catch_line":"Manufacturing and administering Schedule I drugs","url":"\/54.1-3413\/","token":"54.1\/III\/34\/1\/54.1-3413","metadata":false},{"id":72920,"structure_id":13871,"section_number":"54.1-3414","catch_line":"Official orders for Schedule II drugs","url":"\/54.1-3414\/","token":"54.1\/III\/34\/1\/54.1-3414","metadata":false},{"id":75448,"structure_id":13871,"section_number":"54.1-3415","catch_line":"Distribution of drugs in Schedules II through VI by manufacturers and wholesalers","url":"\/54.1-3415\/","token":"54.1\/III\/34\/1\/54.1-3415","metadata":false},{"id":65722,"structure_id":13871,"section_number":"54.1-3415.1","catch_line":"Delivery of medical devices on behalf of a medical equipment supplier","url":"\/54.1-3415.1\/","token":"54.1\/III\/34\/1\/54.1-3415.1","metadata":false},{"id":81317,"structure_id":13871,"section_number":"54.1-3416","catch_line":"No prescription for preparations listed pursuant to Schedule V","url":"\/54.1-3416\/","token":"54.1\/III\/34\/1\/54.1-3416","metadata":false},{"id":85551,"structure_id":13871,"section_number":"54.1-3417","catch_line":"Disposing of stocks of Schedules II through V drugs","url":"\/54.1-3417\/","token":"54.1\/III\/34\/1\/54.1-3417","metadata":false},{"id":57515,"structure_id":13871,"section_number":"54.1-3418","catch_line":"Sale of aqueous or oleaginous solutions","url":"\/54.1-3418\/","token":"54.1\/III\/34\/1\/54.1-3418","metadata":false},{"id":72600,"structure_id":13871,"section_number":"54.1-3419","catch_line":"Dispensing of insulin preparations","url":"\/54.1-3419\/","token":"54.1\/III\/34\/1\/54.1-3419","metadata":false},{"id":83366,"structure_id":13871,"section_number":"54.1-3420","catch_line":"Distribution of certain drugs; written request or confirmation of receipt","url":"\/54.1-3420\/","token":"54.1\/III\/34\/1\/54.1-3420","metadata":false},{"id":79253,"structure_id":13871,"section_number":"54.1-3420.1","catch_line":"Identification required for filling prescriptions","url":"\/54.1-3420.1\/","token":"54.1\/III\/34\/1\/54.1-3420.1","metadata":false},{"id":56483,"structure_id":13871,"section_number":"54.1-3420.2","catch_line":"Delivery of prescription drug order","url":"\/54.1-3420.2\/","token":"54.1\/III\/34\/1\/54.1-3420.2","metadata":false},{"id":55265,"structure_id":13871,"section_number":"54.1-3420.3","catch_line":"Prohibition on refusing to fill prescription from telemedicine provider","url":"\/54.1-3420.3\/","token":"54.1\/III\/34\/1\/54.1-3420.3","metadata":false},{"id":55995,"structure_id":13871,"section_number":"54.1-3421","catch_line":"New drugs","url":"\/54.1-3421\/","token":"54.1\/III\/34\/1\/54.1-3421","metadata":false},{"id":73818,"structure_id":13871,"section_number":"54.1-3422","catch_line":"Controlled substances registration certificate required in addition to other requirements; 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":73818,"structure_id":13871,"section_number":"54.1-3422","catch_line":"Controlled substances registration certificate required in addition to other requirements; exemptions","url":"\/54.1-3422\/","token":"54.1\/III\/34\/1\/54.1-3422","metadata":false},"next_section":{"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},"metadata":false,"official_url":"https:\/\/law.lis.virginia.gov\/vacode\/54.1-3423\/","history_text":"

This law was first created in 1972. The record of its establishment is cataloged in chapter 798 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 1972 \u201cActs\u201d aren\u2019t available online. It has been modified 14 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 1978, chapter 833; in 1980, chapter 288; in 1988, chapter 765; in 1996, chapters 468<\/a> and 496<\/a>; in 1998, chapter 490<\/a>; in 2009, chapters 149<\/a> and 169<\/a>; in 2010, chapter 28<\/a>; in 2014, chapter 148<\/a>; in 2017, chapters 58<\/a> and 110<\/a>; in 2018, chapter 774<\/a>; in 2020, chapter 941<\/a>; in 2023, chapters 744<\/a> and 794<\/a>; in 2024, chapters 63<\/a> and 513<\/a>; in 2025, chapters 278<\/a> and 283<\/a>.<\/p>","references":[{"id":64137,"section_number":"4.1-1602","catch_line":"Permit to operate pharmaceutical processor or cannabis dispensing facility","order_by":null,"url":"\/4.1-1602\/"},{"id":62527,"section_number":"54.1-3801","catch_line":"Exceptions","order_by":null,"url":"\/54.1-3801\/"}],"refers_to":[{"id":86401,"section_number":"3.2-6500","catch_line":"Definitions","order_by":null,"url":"\/3.2-6500\/"},{"id":76036,"section_number":"37.2-100","catch_line":"Definitions","order_by":null,"url":"\/37.2-100\/"},{"id":73818,"section_number":"54.1-3422","catch_line":"Controlled substances registration certificate required in addition to other requirements; exemptions","order_by":null,"url":"\/54.1-3422\/"}],"permalink":{"id":243403,"object_type":"law","relational_id":87135,"identifier":"54.1-3423","token":"54.1\/III\/34\/1\/54.1-3423","url":"\/54.1-3423\/","edition_id":1,"permalink":0,"preferred":1},"url":"\/54.1-3423\/","token":"54.1\/III\/34\/1\/54.1-3423","dublin_core":{"Title":"Board to issue registration unless inconsistent with public interest; authorization to conduct research; application and fees","Type":"Text","Format":"text\/html","Identifier":"\u00a7 54.1-3423","Relation":"Code of Virginia"},"html":"\n\t\t\t\t\t\t

A.<\/span> The Board<\/span> shall register an applicant to manufacture<\/span> or distribute<\/span> controlled substances<\/span> included in Schedules<\/span> I through V unless it determines that the issuance of that registration would be inconsistent with the public interest. In determining the public interest, the Board<\/span> shall consider the following factors: <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

1.<\/span> Maintenance of effective controls against diversion<\/span> of controlled substances<\/span> into other than legitimate medical, scientific, or industrial channels; <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

2.<\/span> Compliance with applicable state and local law<\/span>; <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

3.<\/span> Any convictions<\/span> of the applicant under any federal and state laws<\/span> relating to any controlled substance<\/span>; <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

4.<\/span> Past experience in the manufacture<\/span> or distribution of controlled substances<\/span>, and the existence in the applicant’s establishment of effective controls against diversion<\/span>; <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

5.<\/span> Furnishing by the applicant of false or fraudulent material<\/span> in any application filed under this chapter; <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

6.<\/span> Suspension or revocation<\/span> of the applicant’s federal registration to manufacture<\/span>, distribute<\/span>, or dispense<\/span> controlled substances<\/span> as authorized by federal law<\/span>; and <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

7.<\/span> Any other factors relevant to and consistent with the public health and safety. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

B.<\/span> Registration under subsection A does not entitle a registrant to manufacture<\/span> and distribute<\/span> controlled substances<\/span> in Schedule I or II other than those specified in the registration. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

C.<\/span> Practitioners<\/span> must be registered to conduct research or laboratory analysis with controlled substances<\/span> in Schedules<\/span> II through VI or marijuana<\/span>. Practitioners<\/span> registered under federal law<\/span> to conduct research with Schedule I substances, other than marijuana<\/span>, may conduct research with Schedule I controlled substances<\/span> within the Commonwealth upon furnishing the evidence<\/span> of that federal registration. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

D.<\/span> The Board<\/span> may register other persons<\/span> or entities to possess controlled substances<\/span> listed on Schedules<\/span> II through VI upon a determination that (i) there is a documented need, (ii) the issuance of the registration is consistent with the public interest, (iii) the possession<\/span> and subsequent use of the controlled substances<\/span> complies with applicable state and federal laws<\/span> and regulations, and (iv) the subsequent storage, use, and recordkeeping of the controlled substances<\/span> will be under the general supervision of a licensed pharmacist, practitioner<\/span> of medicine, osteopathy, podiatry, dentistry, or veterinary medicine as specified in the Board<\/span>’s regulations. The Board<\/span> shall consider, at a minimum, the factors listed in subsection A in determining whether the registration shall be issued. Notwithstanding the exceptions listed in subsection A of § 54.1-3422<\/a>, the Board<\/span> may mandate<\/span> a controlled substances<\/span> registration for sites maintaining certain types and quantities of Schedules<\/span> II through VI controlled substances<\/span> as it may specify in its regulations. The Board<\/span> shall promulgate regulations related to requirements or criteria for the issuance of such controlled substances<\/span> registration, storage, security, supervision, and recordkeeping. Notwithstanding the provisions of this subsection or Board<\/span> regulations, the Board<\/span> may register a correctional facility to maintain a floor stock of long-acting injectable or extended-release prescription drugs<\/span> for the treatment of mental illness or substance use disorder. Such long-acting injectable or extended-release prescription drugs<\/span> shall be stored in an area accessible only to persons<\/span> who are licensed to administer<\/span> such prescription drugs<\/span>, regardless of whether the prescriber<\/span> is on site. Each correctional facility shall maintain an ongoing perpetual inventory of all such drugs in Schedules<\/span> II through V. Such perpetual inventory shall (a) accurately indicate the physical count of each drug<\/span> on hand at the time the inventory is performed and (b) no less than once per month, include a reconciliation of each drug<\/span> with a written explanation for any difference between the physical count and the theoretical count. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

E.<\/span> The Board<\/span> may register a public or private animal<\/span> shelter as defined in § 3.2-6500<\/a> to purchase, possess, and administer<\/span> certain Schedules<\/span> II through VI controlled substances<\/span> approved by the State Veterinarian for the purpose of euthanizing injured, sick, homeless, and unwanted domestic pets and animals<\/span> and to purchase, possess, and administer<\/span> certain Schedule VI drugs and biological products<\/span> for the purpose of preventing, controlling, and treating certain communicable diseases that failure to control would result in transmission to the animal<\/span> population in the shelter. Controlled substances<\/span> used for euthanasia shall be administered only in accordance with protocols established by the State Veterinarian and only by persons<\/span> trained in accordance with instructions by the State Veterinarian. The list of Schedule VI drugs and biological products<\/span> used for treatment and prevention of communicable diseases within the shelter shall be determined by the supervising veterinarian of the shelter and the drugs and biological products<\/span> shall be administered only pursuant to written protocols established or approved by the supervising veterinarian of the shelter and only by persons<\/span> who have been trained in accordance with instructions established or approved by the supervising veterinarian. The shelter shall maintain a copy of the approved list of drugs and biological products<\/span>, written protocols for administering, and training records of those persons<\/span> administering drugs and biological products<\/span> on the premises of the shelter. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

F.<\/span> The Board<\/span> may register a facility, as defined in § 37.2-100<\/a>, that provides crisis stabilization services and is licensed by the Department of Behavioral Health and Developmental Services. Such facility may maintain a stock of Schedules<\/span> II through VI controlled substances<\/span> necessary for immediate treatment of patients admitted to such facility, which may be accessed and administered by a person<\/span> licensed to administer<\/span> drugs pursuant to a written or oral order<\/span> of a prescriber<\/span> in the absence of a prescriber<\/span>. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

G.<\/span> The Board<\/span> may register an entity at which a patient is treated by the use of instrumentation and diagnostic equipment through which images and medical records may be transmitted electronically for the purpose of establishing a bona fide practitioner<\/span>-patient relationship and is prescribed Schedules<\/span> II through VI controlled substances<\/span> when such prescribing is in compliance with federal requirements for the practice of telemedicine and the patient is not in the physical presence of a practitioner<\/span> registered with the U.S. Drug<\/span> Enforcement Administration. In determining whether the registration shall be issued, the Board<\/span> shall consider (i) the factors listed in subsection A, (ii) whether there is a documented need for such registration, and (iii) whether the issuance of the registration is consistent with the public interest. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

H.<\/span> Applications for controlled substances<\/span> registration certificates and renewals thereof shall be made on a form prescribed by the Board<\/span> and such applications shall be accompanied by a fee in an amount to be determined by the Board<\/span>. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

I.<\/span> Upon (i) any change in ownership or control of a business, (ii) any change of location of the controlled substances<\/span> stock, (iii) the termination of authority by or of the person<\/span> named as the responsible party<\/span> on a controlled substances<\/span> registration, or (iv) a change in the supervising practitioner<\/span>, if applicable, the registrant or responsible party<\/span> shall immediately surrender the registration. The registrant shall, within 14 days following surrender of a registration, file a new application and, if applicable, name the new responsible party<\/span> or supervising practitioner<\/span>. <\/i><\/a><\/p><\/section>","plain_text":" CODE OF VIRGINIA\n\nBOARD TO ISSUE REGISTRATION UNLESS INCONSISTENT WITH PUBLIC INTEREST;\nAUTHORIZATION TO CONDUCT RESEARCH; APPLICATION AND FEES (\u00a7 54.1-3423)\n\nA. The Board shall register an applicant to manufacture or distribute controlled\nsubstances included in Schedules I through V unless it determines that the\nissuance of that registration would be inconsistent with the public interest. In\ndetermining the public interest, the Board shall consider the following factors:\n\n 1. Maintenance of effective controls against diversion of controlled\n substances into other than legitimate medical, scientific, or industrial\n channels;\n\n 2. Compliance with applicable state and local law;\n\n 3. Any convictions of the applicant under any federal and state laws relating\n to any controlled substance;\n\n 4. Past experience in the manufacture or distribution of controlled\n substances, and the existence in the applicant’s establishment of\n effective controls against diversion;\n\n 5. Furnishing by the applicant of false or fraudulent material in any\n application filed under this chapter;\n\n 6. Suspension or revocation of the applicant’s federal registration to\n manufacture, distribute, or dispense controlled substances as authorized by\n federal law; and\n\n 7. Any other factors relevant to and consistent with the public health and\n safety.\n\nB. Registration under subsection A does not entitle a registrant to manufacture\nand distribute controlled substances in Schedule I or II other than those\nspecified in the registration.\n\nC. Practitioners must be registered to conduct research or laboratory analysis\nwith controlled substances in Schedules II through VI or marijuana.\nPractitioners registered under federal law to conduct research with Schedule I\nsubstances, other than marijuana, may conduct research with Schedule I\ncontrolled substances within the Commonwealth upon furnishing the evidence of\nthat federal registration.\n\nD. The Board may register other persons or entities to possess controlled\nsubstances listed on Schedules II through VI upon a determination that (i) there\nis a documented need, (ii) the issuance of the registration is consistent with\nthe public interest, (iii) the possession and subsequent use of the controlled\nsubstances complies with applicable state and federal laws and regulations, and\n(iv) the subsequent storage, use, and recordkeeping of the controlled substances\nwill be under the general supervision of a licensed pharmacist, practitioner of\nmedicine, osteopathy, podiatry, dentistry, or veterinary medicine as specified\nin the Board’s regulations. The Board shall consider, at a minimum, the\nfactors listed in subsection A in determining whether the registration shall be\nissued. Notwithstanding the exceptions listed in subsection A of §\n54.1-3422, the Board may mandate a controlled substances registration for sites\nmaintaining certain types and quantities of Schedules II through VI controlled\nsubstances as it may specify in its regulations. The Board shall promulgate\nregulations related to requirements or criteria for the issuance of such\ncontrolled substances registration, storage, security, supervision, and\nrecordkeeping. Notwithstanding the provisions of this subsection or Board\nregulations, the Board may register a correctional facility to maintain a floor\nstock of long-acting injectable or extended-release prescription drugs for the\ntreatment of mental illness or substance use disorder. Such long-acting\ninjectable or extended-release prescription drugs shall be stored in an area\naccessible only to persons who are licensed to administer such prescription\ndrugs, regardless of whether the prescriber is on site. Each correctional\nfacility shall maintain an ongoing perpetual inventory of all such drugs in\nSchedules II through V. Such perpetual inventory shall (a) accurately indicate\nthe physical count of each drug on hand at the time the inventory is performed\nand (b) no less than once per month, include a reconciliation of each drug with\na written explanation for any difference between the physical count and the\ntheoretical count.\n\nE. The Board may register a public or private animal shelter as defined in\n§ 3.2-6500 to purchase, possess, and administer certain Schedules II\nthrough VI controlled substances approved by the State Veterinarian for the\npurpose of euthanizing injured, sick, homeless, and unwanted domestic pets and\nanimals and to purchase, possess, and administer certain Schedule VI drugs and\nbiological products for the purpose of preventing, controlling, and treating\ncertain communicable diseases that failure to control would result in\ntransmission to the animal population in the shelter. Controlled substances used\nfor euthanasia shall be administered only in accordance with protocols\nestablished by the State Veterinarian and only by persons trained in accordance\nwith instructions by the State Veterinarian. The list of Schedule VI drugs and\nbiological products used for treatment and prevention of communicable diseases\nwithin the shelter shall be determined by the supervising veterinarian of the\nshelter and the drugs and biological products shall be administered only\npursuant to written protocols established or approved by the supervising\nveterinarian of the shelter and only by persons who have been trained in\naccordance with instructions established or approved by the supervising\nveterinarian. The shelter shall maintain a copy of the approved list of drugs\nand biological products, written protocols for administering, and training\nrecords of those persons administering drugs and biological products on the\npremises of the shelter.\n\nF. The Board may register a facility, as defined in § 37.2-100, that\nprovides crisis stabilization services and is licensed by the Department of\nBehavioral Health and Developmental Services. Such facility may maintain a stock\nof Schedules II through VI controlled substances necessary for immediate\ntreatment of patients admitted to such facility, which may be accessed and\nadministered by a person licensed to administer drugs pursuant to a written or\noral order of a prescriber in the absence of a prescriber.\n\nG. The Board may register an entity at which a patient is treated by the use of\ninstrumentation and diagnostic equipment through which images and medical\nrecords may be transmitted electronically for the purpose of establishing a bona\nfide practitioner-patient relationship and is prescribed Schedules II through VI\ncontrolled substances when such prescribing is in compliance with federal\nrequirements for the practice of telemedicine and the patient is not in the\nphysical presence of a practitioner registered with the U.S. Drug Enforcement\nAdministration. In determining whether the registration shall be issued, the\nBoard shall consider (i) the factors listed in subsection A, (ii) whether there\nis a documented need for such registration, and (iii) whether the issuance of\nthe registration is consistent with the public interest.\n\nH. Applications for controlled substances registration certificates and renewals\nthereof shall be made on a form prescribed by the Board and such applications\nshall be accompanied by a fee in an amount to be determined by the Board.\n\nI. Upon (i) any change in ownership or control of a business, (ii) any change of\nlocation of the controlled substances stock, (iii) the termination of authority\nby or of the person named as the responsible party on a controlled substances\nregistration, or (iv) a change in the supervising practitioner, if applicable,\nthe registrant or responsible party shall immediately surrender the\nregistration. The registrant shall, within 14 days following surrender of a\nregistration, file a new application and, if applicable, name the new\nresponsible party or supervising practitioner.\n\nHISTORY: 1972, c. 798, \u00a7 54-524.47:3; 1978, c. 833; 1980, c. 288; 1988, c. 765;\n1996, cc. 468, 496; 1998, c. 490; 2009, cc. 149, 169; 2010, c. 28; 2014, c. 148;\n2017, cc. 58, 110; 2018, c. 774; 2020, c. 941; 2023, cc. 744, 794; 2024, cc. 63,\n513; 2025, cc. 278, 283.","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}}