Title 54.1, Professions and Occupations

A. Hospitals or nursing homes licensed pursuant to Title 32.1, state facilities as defined in § 37.2-100 established pursuant to Title 37.2, facilities as defined in § 37.2-100 that are licensed by the Department of Behavioral Health and Developmental Services and provide site-ba…

Each pharmacy shall implement a program for continuous quality improvement, according to regulations of the Board. Such program shall provide for a systematic, ongoing process of analysis of dispensing errors that uses findings to formulate an appropriate response and to develop …

The Board of Pharmacy shall, in cases in which a monetary fine may be imposed for a violation of the provisions of Article 2 (§ 54.1-3432 et seq.) of the Drug Control Act relating to the practice of pharmacy and the pharmacy subject to the fine is affiliated with a free clinic th…

A. No person shall act as an outsourcing facility without first obtaining a permit from the Board. B. Applications for a permit to act as an outsourcing facility shall be made on a form provided by the Board and signed by a pharmacist who will be in full and actual charge of the …

A. It shall be unlawful for any person to engage in the wholesale distribution of prescription drugs in the Commonwealth without a valid unrevoked license issued by the Board. The applicant for licensure as a wholesale distributor, as defined in § 54.1-3401, in the Commonwealth s…

A. 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…

A. A permitted pharmacy may engage in wholesale distributions of small quantities of prescription drugs without being licensed as wholesale distributors when such wholesale distributions are in compliance with federal law as follows: such wholesale distributions of controlled sub…

A. The Board may deny, revoke, suspend, or take other disciplinary actions against a wholesale distributor license, nonresident wholesale distributor registration, third-party logistics provider permit, nonresident third-party logistics provider registration, manufacturer permit,…

A. Unless otherwise authorized by this chapter or Chapter 33 (§ 54.1-3300 et seq.) of this title, it shall be unlawful for any person to act as a medical equipment supplier, as defined in § 54.1-3401, in this Commonwealth without a valid unrevoked permit issued by the Board. The …

Medical equipment suppliers shall allow the Board or its authorized agents to enter and inspect, at reasonable times and in a reasonable manner, their premises and delivery vehicles, and to audit their records and written operating procedures.

A. Any person located outside the Commonwealth other than a nonresident pharmacy registered pursuant to § 54.1-3434.1 that ships, mails, or delivers to a consumer in the Commonwealth any hypodermic syringes or needles, medicinal oxygen, Schedule VI controlled device, those Schedu…

A. Unless otherwise authorized by this chapter or Chapter 33 (§ 54.1-3300 et seq.) of this title, it shall be unlawful for any person to act as a warehouser, as defined in § 54.1-3401, in this Commonwealth without a valid unrevoked permit issued by the Board. The applicant for a …

A. Any warehouser located outside the Commonwealth that ships prescription drugs or devices into the Commonwealth shall be registered with the Board. Such nonresident warehouser shall renew such registration annually on a date determined by the Board and shall notify the Board wi…

A. It shall be unlawful for any person to operate as a third-party logistics provider in the Commonwealth without a valid, unrevoked permit issued by the Board. The third-party logistics provider shall renew such permit annually on a date determined by the Board in regulation and…

A. Any third-party logistics provider located outside the Commonwealth that ships prescription drugs or devices into the Commonwealth shall be registered with the Board. Such nonresident third-party logistics provider shall renew such registration annually on a date determined by…

A. As used in this section: "Brand-name drug" means a prescription drug approved under 21 U.S.C. § 355(b) or 42 U.S.C. § 262. "Generic drug" means a prescription drug approved under 21 U.S.C. § 355(j). "Nonprofit data services organization" has the same meaning as set forth in § …

It shall be lawful to manufacture, make, produce, pack, package, repackage, relabel or prepare any drug not controlled by Schedule I after first obtaining the appropriate permit from the Board. Such permits shall be subject to the Board's regulations on sanitation, equipment, and…

The Board may issue a limited manufacturing permit for the purpose of repackaging drugs, upon such terms and conditions approved by the Board, to the pharmacy directly operated by the Department of Behavioral Health and Developmental Services and which serves clients of the commu…

No drugs or proprietary medicines shall be manufactured, made, produced, packed, packaged, repackaged, relabeled or prepared within this Commonwealth, except under the personal and immediate supervision of a pharmacist or such other person as may be approved by the Board of Pharm…

Every person desiring to manufacture any drug or proprietary medicines shall annually apply to the Board for a nonrestricted manufacturing permit. The application shall be accompanied by the required fee. Separate applications shall be made and separate permits issued for each sp…

No person shall be granted a nonrestricted permit as a manufacturer unless he is of good moral character and properly equipped as to land, buildings, equipment and safeguards against diversion to carry out the functions of a manufacturer with due regard to the protection of the p…

Every person desiring to manufacture a proprietary medicine or to repackage medical gases shall apply to the Board for a restricted manufacturing permit. The application shall be accompanied by the required fee. Separate applications shall be made and separate permits issued for …

No person shall be granted a restricted manufacturing permit as a manufacturer unless such person is properly equipped as to buildings and equipment to carry out the functions of a manufacturer with due regard to the protection of the public health. The Board shall promulgate reg…

A. Any manufacturer located outside the Commonwealth who ships prescription drugs into the Commonwealth shall be registered with the Board. The nonresident manufacturer shall renew such registration annually on a date determined by the Board in regulation and shall notify the Boa…

A. As used in this section: "Biosimilar" means a drug that is produced or distributed pursuant to a biologics license application approved under 42 U.S.C. § 262(k)(3). "Brand-name drug" means a prescription drug approved under 21 U.S.C. § 355(b) or 42 U.S.C. § 262. "Generic drug"…

A. The Board shall administer this article and may add substances to or deschedule or reschedule all substances enumerated in the schedules in this article pursuant to the procedures of the Administrative Process Act (§ 2.2-4000 et seq.). In making a determination regarding a sub…

The controlled substances listed or to be listed in the schedules in this chapter are included by whatever official, common, usual, chemical, or trade name designated.

The Board shall place a substance in Schedule I if it finds that the substance: 1. Has high potential for abuse; and 2. Has no accepted medical use in treatment in the United States or lacks accepted safety for use in treatment under medical supervision.

The controlled substances listed in this section are included in Schedule I: 1. Any of the following opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, unless specifically excepted, whenever the existence of these isomers, esters, e…

The Board shall place a substance in Schedule II if it finds that: 1. The substance has high potential for abuse; 2. The substance has currently accepted medical use in treatment in the United States, or currently accepted medical use with severe restrictions; and 3. The abuse of…

The controlled substances listed in this section are included in Schedule II: 1. Any of the following substances, except those narcotic drugs listed in other schedules, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by …

The Board shall place a substance in Schedule III if it finds that: 1. The substance has a potential for abuse less than the substances listed in Schedules I and II; 2. The substance has currently accepted medical use in treatment in the United States; and 3. Abuse of the substan…

The controlled substances listed in this section are included in Schedule III: 1. Unless specifically exempted or listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a depressant effect on the …

The Board shall place a substance in Schedule IV if it finds that: 1. The substance has a low potential for abuse relative to substances in Schedule III; 2. The substance has currently accepted medical use in treatment in the United States; and 3. Abuse of the substance may lead …

The controlled substances listed in this section are included in Schedule IV unless specifically excepted or listed in another schedule: 1. Any material, compound, mixture, or preparation which contains any quantity of the following substances having a potential for abuse associa…

The Board shall place a substance in Schedule V if it finds that: 1. The substance has low potential for abuse relative to the controlled substances listed in Schedule IV; 2. The substance has currently accepted medical use in treatment in the United States; and 3. The substance …

The controlled substances listed in this section are included in Schedule V: 1. Any compound, mixture, or preparation containing limited quantities of any of the following narcotic drugs, which also contains one or more nonnarcotic active medicinal ingredients in sufficient propo…

The following classes of drugs and devices shall be controlled by Schedule VI: 1. Any compound, mixture, or preparation containing any stimulant or depressant drug exempted from Schedules III, IV or V and designated by the Board as subject to this section. 2. Every drug, not incl…

A controlled substance analog shall, to the extent intended for human consumption, be treated, for the purposes of any state law, as a controlled substance in Schedule I or II. A controlled substance analog shall be considered to be listed on the same schedule as the drug or clas…

The Board may promulgate regulations designating specific drugs and substances, including any controlled substance or other drug or substance where there has been or there is the actual or relative potential for abuse, as drugs of concern. Drugs or substances designated as drugs …

The following acts shall be prohibited: 1. The manufacture, sale, delivery, holding, or offering for sale of any drug, device, or cosmetic that is adulterated or misbranded. 2. The adulteration or misbranding of any drug, device, or cosmetic. 3. The receipt in commerce of any dru…

A. Any person who violates any of the provisions of § 54.1-3457 shall be guilty of a Class 6 felony. B. No person shall be subject to the penalties of this section for having violated subdivisions 1 and 3 of § 54.1-3457 if he establishes a guaranty or undertaking signed by, and c…

A. Whenever a duly authorized agent of the Board finds, or has probable cause to believe, that any drug, device, or cosmetic is adulterated, or so misbranded as to be dangerous or fraudulent, within the meaning of this chapter or is in violation of § 54.1-3457, he shall affix to …

Any added poisonous or deleterious substance, or any color additive, shall with respect to any particular use or intended use be deemed unsafe with respect to any drug, device, or cosmetic, unless there is a regulation allowing limited use of a quantity of such substance, and the…

A. A drug or device shall be deemed to be adulterated: 1. If it consists in whole or in part of any filth, putrid or decomposed substance; 2. If it has been produced, prepared, packed, or held under insanitary conditions whereby it has been contaminated with filth, or whereby it …

A drug or device shall be deemed to be misbranded: 1. If its labeling is false or misleading in any particular. 2. If its package does not bear a label containing the name and place of business of the manufacturer, packer, or distributor. However, all prescription drugs intended …