Title 54.1, Title 54.1. Professions and Occupations

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"…

As used in this article, unless the context requires a different meaning: "Investigational drug, biological product, or device" means a drug, biological product, or device that has successfully completed Phase I of a clinical trial but has not been approved for general use by the…

A. A person shall be eligible for expanded access to investigational drugs, biological products, or devices if: 1. He has a terminal condition, attested to by his treating physician and confirmed by a second physician not previously involved in the treatment of the person who has…

A. A manufacturer of an investigational drug, biological product, or device may make such investigational drug, biological product, or device available to a person who meets the criteria set forth in subsection A of § 54.1-3442.2; however, nothing in this article shall require a …

A. Notwithstanding any other provision of law to the contrary, a health care provider as defined in § 8.01-581.1 who recommends an investigational drug, biological product, or device to a person who meets the criteria set forth in subsection A of § 54.1-3442.2 shall be immune fro…

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 …

A. Any drug dispensed by filling or refilling a written or oral prescription of a prescriber shall be exempt from the requirements of § 54.1-3462 except subdivisions 1, 9, and 10, and the packaging requirements of subdivision 7, if the drug bears a label containing the name and a…

A cosmetic shall be deemed to be adulterated: 1. If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling or advertisement, or under such conditions of use as are customary or usua…

A cosmetic shall be deemed to be misbranded: 1. If its labeling is false or misleading in any particular; 2. If in package form unless it bears a label containing the name and place of business of the manufacturer, packer, or distributor and an accurate statement of the quantity …

A. For purposes of this chapter, "controlled paraphernalia" means (i) a hypodermic syringe, needle, or other instrument or implement or combination thereof adapted for the administration of controlled dangerous substances by hypodermic injections under circumstances that reasonab…

A. Distribution by any method, of any hypodermic needles or syringes, gelatin capsules, quinine or any of its salts, in excess of one-fourth ounce shall be restricted to licensed pharmacists or to others who have received a license or a permit from the Board. B. Nothing in this s…

In dispensing any device, item or substance, the pharmacist or other licensed or permitted person referred to in § 54.1-3467 shall: 1. Require the person requesting such device, item or substance to furnish suitable identification, including proof of age when appropriate; 2. Requ…

Each person, association or corporation which has lawfully obtained possession of any of the controlled paraphernalia mentioned in § 54.1-3467 shall exercise reasonable care in the storage, usage and disposition of such devices or substances to ensure that they are not diverted f…

A. No person shall obtain or attempt to obtain any item, device or substance referred to in § 54.1-3467 by fraud, deceit, misrepresentation, or subterfuge or by giving a false name or a false address. B. No person shall furnish false or fraudulent information in or omit any infor…

The Board shall, upon written application, on a form furnished by the Board, issue a permit to any person other than a licensed pharmacist who in the usual course of business sells any item referred to in § 54.1-3467 as a wholesale distributor or distributes at retail to any pers…

The provisions of this article shall not apply to legitimate distribution by or possession of controlled paraphernalia by physicians, dentists, podiatrists, veterinarians, funeral directors and embalmers. 1971, Ex. Sess., cc. 210, 245; 1988, c. 765.

A. A licensed substance abuse treatment practitioner shall be qualified to (i) perform on an independent basis the substance abuse treatment functions of screening, intake, orientation, assessment, treatment planning, treatment, case management, substance abuse or dependence cris…

A. The Board shall establish a pathway for licensure by endorsement as a licensed substance abuse treatment practitioner for individuals who: 1. Have held certification as a certified substance abuse counselor for at least 10 years prior to the date of application and have active…

A. A certified substance abuse counselor shall be (i) qualified to perform, under appropriate supervision or direction, the substance abuse treatment functions of screening, intake, orientation, the administration of substance abuse assessment instruments, recovery and relapse pr…

A. A certified substance abuse counseling assistant shall be qualified to perform, under appropriate supervision or direction, the substance abuse treatment functions of orientation, implementation of substance abuse treatment plans, case management, substance abuse or dependence…

No person shall claim to be, or use the title of, a substance abuse treatment practitioner, a substance abuse counselor, or a substance abuse counseling assistant unless he has been licensed or certified as such pursuant to §§ 54.1-3507, 54.1-3507.1 or § 54.1-3507.2.

Notwithstanding the provisions of § 54.1-3507, (i) the Board may issue a license as a licensed substance abuse treatment practitioner to a person who, after the effective date of the regulations promulgated pursuant to subdivision 7 of § 54.1-3505, has applied for such a license …

On and after July 1, 2001, unless such certification is suspended or revoked by the Board, the Board shall continue to certify as a certified substance abuse counselor any person (i) who was certified by the Board as a certified substance abuse counselor prior to July 1, 2001, or…