§ 54.1-3423. Board to issue registration unless inconsistent with publicinterest; authorization to conduct research; application and fees.
A. The Board shall register an applicant to manufacture or distributecontrolled substances included in Schedules I through V unless it determinesthat the issuance of that registration would be inconsistent with the publicinterest. In determining the public interest, the Board shall consider thefollowing factors:
1. Maintenance of effective controls against diversion of controlledsubstances into other than legitimate medical, scientific, or industrialchannels;
2. Compliance with applicable state and local law;
3. Any convictions of the applicant under any federal and state laws relatingto any controlled substance;
4. Past experience in the manufacture or distribution of controlledsubstances, and the existence in the applicant's establishment of effectivecontrols against diversion;
5. Furnishing by the applicant of false or fraudulent material in anyapplication filed under this chapter;
6. Suspension or revocation of the applicant's federal registration tomanufacture, distribute, or dispense controlled substances as authorized byfederal law; and
7. Any other factors relevant to and consistent with the public health andsafety.
B. Registration under subsection A does not entitle a registrant tomanufacture and distribute controlled substances in Schedule I or II otherthan those specified in the registration.
C. Practitioners must be registered to conduct research with controlledsubstances in Schedules II through VI. Practitioners registered under federallaw to conduct research with Schedule I substances may conduct research withSchedule I substances within this Commonwealth upon furnishing the evidenceof that federal registration.
D. The Board may register other persons or entities to possess controlledsubstances listed on Schedules II through VI upon a determination that (i)there is a documented need, (ii) the issuance of the registration isconsistent with the public interest, (iii) the possession and subsequent useof the controlled substances complies with applicable state and federal lawsand regulations, and (iv) the subsequent storage, use, and recordkeeping ofthe controlled substances will be under the general supervision of a licensedpharmacist, practitioner of medicine, osteopathy, podiatry, dentistry orveterinary medicine as specified in the Board's regulations. The Board shallconsider, at a minimum, the factors listed in subsection A of this section indetermining whether the registration shall be issued. Notwithstanding theexceptions listed in § 54.1-3422 A, the Board may mandate a controlledsubstances registration for sites maintaining certain types and quantities ofSchedules II through VI controlled substances as it may specify in itsregulations. The Board shall promulgate regulations related to requirementsor criteria for the issuance of such controlled substances registration,storage, security, supervision, and recordkeeping.
E. The Board may register an animal shelter or pound as defined in § 3.2-6500to purchase, possess, and administer certain Schedule II-VI controlledsubstances approved by the State Veterinarian for the purpose of euthanizinginjured, sick, homeless, and unwanted domestic pets and animals; and topurchase, possess, and administer certain Schedule VI controlled substancesfor the purpose of preventing, controlling, and treating certain communicablediseases that failure to control would result in transmission to the animalpopulation in the shelter or pound. The drugs used for euthanasia shall beadministered only in accordance with protocols established by the StateVeterinarian and only by persons trained in accordance with instructions bythe State Veterinarian. The list of Schedule VI drugs used for treatment andprevention of communicable diseases within the animal shelter or pound shallbe determined by the supervising veterinarian of the shelter or pound and thedrugs shall be administered only pursuant to written protocols established orapproved by the supervising veterinarian of the shelter or pound and only bypersons who have been trained in accordance with instructions established orapproved by the supervising veterinarian. The shelter or pound shall maintaina copy of the approved list of drugs, written protocols for administering,and training records of those persons administering drugs on the premises ofthe shelter or pound.
F. The Board may register a crisis stabilization unit established pursuant to§ 37.2-500 or 37.2-601 and licensed by the Department of Behavioral Healthand Developmental Services to maintain a stock of Schedule VI controlledsubstances necessary for immediate treatment of patients admitted to thecrisis stabilization unit, which may be accessed and administered by a nursepursuant to a written or oral order of a prescriber in the absence of aprescriber. Schedule II through Schedule V controlled substances shall onlybe maintained if so authorized by federal law and Board regulations.
G. Applications for controlled substances registration certificates andrenewals thereof shall be made on a form prescribed by the Board and suchapplications shall be accompanied by a fee in an amount to be determined bythe Board.
H. Upon (i) any change in ownership or control of a business, (ii) any changeof location of the controlled substances stock, (iii) the termination ofauthority by or of the person named as the responsible party on a controlledsubstances registration, or (iv) a change in the supervising practitioner, ifapplicable, the registrant or responsible party shall immediately surrenderthe registration. The registrant shall, within fourteen days followingsurrender of a registration, file a new application and, if applicable, namethe new responsible party or supervising practitioner.
(1972, c. 798, § 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.)
§ 54.1-3423. Board to issue registration unless inconsistent with publicinterest; authorization to conduct research; application and fees.
A. The Board shall register an applicant to manufacture or distributecontrolled substances included in Schedules I through V unless it determinesthat the issuance of that registration would be inconsistent with the publicinterest. In determining the public interest, the Board shall consider thefollowing factors:
1. Maintenance of effective controls against diversion of controlledsubstances into other than legitimate medical, scientific, or industrialchannels;
2. Compliance with applicable state and local law;
3. Any convictions of the applicant under any federal and state laws relatingto any controlled substance;
4. Past experience in the manufacture or distribution of controlledsubstances, and the existence in the applicant's establishment of effectivecontrols against diversion;
5. Furnishing by the applicant of false or fraudulent material in anyapplication filed under this chapter;
6. Suspension or revocation of the applicant's federal registration tomanufacture, distribute, or dispense controlled substances as authorized byfederal law; and
7. Any other factors relevant to and consistent with the public health andsafety.
B. Registration under subsection A does not entitle a registrant tomanufacture and distribute controlled substances in Schedule I or II otherthan those specified in the registration.
C. Practitioners must be registered to conduct research with controlledsubstances in Schedules II through VI. Practitioners registered under federallaw to conduct research with Schedule I substances may conduct research withSchedule I substances within this Commonwealth upon furnishing the evidenceof that federal registration.
D. The Board may register other persons or entities to possess controlledsubstances listed on Schedules II through VI upon a determination that (i)there is a documented need, (ii) the issuance of the registration isconsistent with the public interest, (iii) the possession and subsequent useof the controlled substances complies with applicable state and federal lawsand regulations, and (iv) the subsequent storage, use, and recordkeeping ofthe controlled substances will be under the general supervision of a licensedpharmacist, practitioner of medicine, osteopathy, podiatry, dentistry orveterinary medicine as specified in the Board's regulations. The Board shallconsider, at a minimum, the factors listed in subsection A of this section indetermining whether the registration shall be issued. Notwithstanding theexceptions listed in § 54.1-3422 A, the Board may mandate a controlledsubstances registration for sites maintaining certain types and quantities ofSchedules II through VI controlled substances as it may specify in itsregulations. The Board shall promulgate regulations related to requirementsor criteria for the issuance of such controlled substances registration,storage, security, supervision, and recordkeeping.
E. The Board may register an animal shelter or pound as defined in § 3.2-6500to purchase, possess, and administer certain Schedule II-VI controlledsubstances approved by the State Veterinarian for the purpose of euthanizinginjured, sick, homeless, and unwanted domestic pets and animals; and topurchase, possess, and administer certain Schedule VI controlled substancesfor the purpose of preventing, controlling, and treating certain communicablediseases that failure to control would result in transmission to the animalpopulation in the shelter or pound. The drugs used for euthanasia shall beadministered only in accordance with protocols established by the StateVeterinarian and only by persons trained in accordance with instructions bythe State Veterinarian. The list of Schedule VI drugs used for treatment andprevention of communicable diseases within the animal shelter or pound shallbe determined by the supervising veterinarian of the shelter or pound and thedrugs shall be administered only pursuant to written protocols established orapproved by the supervising veterinarian of the shelter or pound and only bypersons who have been trained in accordance with instructions established orapproved by the supervising veterinarian. The shelter or pound shall maintaina copy of the approved list of drugs, written protocols for administering,and training records of those persons administering drugs on the premises ofthe shelter or pound.
F. The Board may register a crisis stabilization unit established pursuant to§ 37.2-500 or 37.2-601 and licensed by the Department of Behavioral Healthand Developmental Services to maintain a stock of Schedule VI controlledsubstances necessary for immediate treatment of patients admitted to thecrisis stabilization unit, which may be accessed and administered by a nursepursuant to a written or oral order of a prescriber in the absence of aprescriber. Schedule II through Schedule V controlled substances shall onlybe maintained if so authorized by federal law and Board regulations.
G. Applications for controlled substances registration certificates andrenewals thereof shall be made on a form prescribed by the Board and suchapplications shall be accompanied by a fee in an amount to be determined bythe Board.
H. Upon (i) any change in ownership or control of a business, (ii) any changeof location of the controlled substances stock, (iii) the termination ofauthority by or of the person named as the responsible party on a controlledsubstances registration, or (iv) a change in the supervising practitioner, ifapplicable, the registrant or responsible party shall immediately surrenderthe registration. The registrant shall, within fourteen days followingsurrender of a registration, file a new application and, if applicable, namethe new responsible party or supervising practitioner.
(1972, c. 798, § 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.)
§ 54.1-3423. Board to issue registration unless inconsistent with publicinterest; authorization to conduct research; application and fees.
A. The Board shall register an applicant to manufacture or distributecontrolled substances included in Schedules I through V unless it determinesthat the issuance of that registration would be inconsistent with the publicinterest. In determining the public interest, the Board shall consider thefollowing factors:
1. Maintenance of effective controls against diversion of controlledsubstances into other than legitimate medical, scientific, or industrialchannels;
2. Compliance with applicable state and local law;
3. Any convictions of the applicant under any federal and state laws relatingto any controlled substance;
4. Past experience in the manufacture or distribution of controlledsubstances, and the existence in the applicant's establishment of effectivecontrols against diversion;
5. Furnishing by the applicant of false or fraudulent material in anyapplication filed under this chapter;
6. Suspension or revocation of the applicant's federal registration tomanufacture, distribute, or dispense controlled substances as authorized byfederal law; and
7. Any other factors relevant to and consistent with the public health andsafety.
B. Registration under subsection A does not entitle a registrant tomanufacture and distribute controlled substances in Schedule I or II otherthan those specified in the registration.
C. Practitioners must be registered to conduct research with controlledsubstances in Schedules II through VI. Practitioners registered under federallaw to conduct research with Schedule I substances may conduct research withSchedule I substances within this Commonwealth upon furnishing the evidenceof that federal registration.
D. The Board may register other persons or entities to possess controlledsubstances listed on Schedules II through VI upon a determination that (i)there is a documented need, (ii) the issuance of the registration isconsistent with the public interest, (iii) the possession and subsequent useof the controlled substances complies with applicable state and federal lawsand regulations, and (iv) the subsequent storage, use, and recordkeeping ofthe controlled substances will be under the general supervision of a licensedpharmacist, practitioner of medicine, osteopathy, podiatry, dentistry orveterinary medicine as specified in the Board's regulations. The Board shallconsider, at a minimum, the factors listed in subsection A of this section indetermining whether the registration shall be issued. Notwithstanding theexceptions listed in § 54.1-3422 A, the Board may mandate a controlledsubstances registration for sites maintaining certain types and quantities ofSchedules II through VI controlled substances as it may specify in itsregulations. The Board shall promulgate regulations related to requirementsor criteria for the issuance of such controlled substances registration,storage, security, supervision, and recordkeeping.
E. The Board may register an animal shelter or pound as defined in § 3.2-6500to purchase, possess, and administer certain Schedule II-VI controlledsubstances approved by the State Veterinarian for the purpose of euthanizinginjured, sick, homeless, and unwanted domestic pets and animals; and topurchase, possess, and administer certain Schedule VI controlled substancesfor the purpose of preventing, controlling, and treating certain communicablediseases that failure to control would result in transmission to the animalpopulation in the shelter or pound. The drugs used for euthanasia shall beadministered only in accordance with protocols established by the StateVeterinarian and only by persons trained in accordance with instructions bythe State Veterinarian. The list of Schedule VI drugs used for treatment andprevention of communicable diseases within the animal shelter or pound shallbe determined by the supervising veterinarian of the shelter or pound and thedrugs shall be administered only pursuant to written protocols established orapproved by the supervising veterinarian of the shelter or pound and only bypersons who have been trained in accordance with instructions established orapproved by the supervising veterinarian. The shelter or pound shall maintaina copy of the approved list of drugs, written protocols for administering,and training records of those persons administering drugs on the premises ofthe shelter or pound.
F. The Board may register a crisis stabilization unit established pursuant to§ 37.2-500 or 37.2-601 and licensed by the Department of Behavioral Healthand Developmental Services to maintain a stock of Schedule VI controlledsubstances necessary for immediate treatment of patients admitted to thecrisis stabilization unit, which may be accessed and administered by a nursepursuant to a written or oral order of a prescriber in the absence of aprescriber. Schedule II through Schedule V controlled substances shall onlybe maintained if so authorized by federal law and Board regulations.
G. Applications for controlled substances registration certificates andrenewals thereof shall be made on a form prescribed by the Board and suchapplications shall be accompanied by a fee in an amount to be determined bythe Board.
H. Upon (i) any change in ownership or control of a business, (ii) any changeof location of the controlled substances stock, (iii) the termination ofauthority by or of the person named as the responsible party on a controlledsubstances registration, or (iv) a change in the supervising practitioner, ifapplicable, the registrant or responsible party shall immediately surrenderthe registration. The registrant shall, within fourteen days followingsurrender of a registration, file a new application and, if applicable, namethe new responsible party or supervising practitioner.
(1972, c. 798, § 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.)
