reglab/statecodes huggingface dataset:
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3436.1. Prescription drug price transparency

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 § 32.1-23.4.
"Pharmacy benefits manager" has the same meaning as set forth in § 38.2-3407.15:4.
"Wholesale acquisition cost" has the same meaning as set forth in 42 U.S.C. § 1395w-3a(c)(6)(B).
B. To ensure data that is useful, relevant, and not duplicative, the Department of Health may request wholesale distributors to report to the nonprofit organization with which the Department of Health has entered into a contract or agreement pursuant to § 32.1-23.4 the following information on the 25 costliest drugs in the Commonwealth upon a determination by the Department of Health that data received from health carriers, pharmacy benefits managers, and manufacturers is insufficient:
1. The wholesale acquisition cost that the wholesale distributor has negotiated directly with the manufacturer in the last calendar year, related to the 25 costliest drugs dispensed in the Commonwealth;
2. The wholesale acquisition cost that the wholesale distributor has negotiated directly with the manufacturer in the current calendar year for the 25 costliest drugs dispensed in the Commonwealth;
3. Aggregate total rebates, discounts, and price concessions negotiated directly with the manufacturer for the 25 costliest drugs dispensed in the Commonwealth in the last calendar year, for business in the Commonwealth, in total; and
4. Aggregate total discounts, dispensing fees, and other fees negotiated in the last calendar year with pharmacies, for the 25 costliest drugs dispensed in the Commonwealth, in total.
C. A report submitted by a wholesale distributor pursuant to subsection B shall not disclose the identity of a specific wholesale distributor, the price charged for a specific prescription drug or class of prescription drugs, or the amount of any price concession, rebate, or fee provided for a specific prescription drug or class of prescription drugs.
2021, Sp. Sess. I, c. 304.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3437. Permit to manufacture drugs

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 safeguards against diversion, and shall allow the distribution of the drug manufactured, made, produced, packed, packaged, repackaged, relabeled, or prepared to anyone other than the end user without the need to obtain a wholesale distributor permit. This provision shall not apply to manufacturers or packers of medicated feeds who manufacture or package no other drugs.
Code 1950, § 54-448; 1958, c. 551; 1970, c. 650, § 54-524.36; 1988, c. 765; 1996, cc. 37, 407; 2016, c. 221.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3437.1. Limited permit for repackaging drugs

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 community services boards.
1997, c. 218; 2009, cc. 813, 840.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3438. Manufacturing, etc., of drugs or proprietary medicines, to be supervised by pharmacist

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 Pharmacy after an investigation and a determination by the Board that they are qualified by scientific or technical training to perform such duties or supervision as may be necessary to protect the public health and safety. This provision shall not apply to manufacturers or packers of medicated feeds who manufacture or pack no other drugs. Medicated feeds are hereby defined as products obtained by mixing a commercial feed and a drug.
Code 1950, § 54-447; 1958, c. 551; 1970, c. 650, § 54-524.37; 1976, c. 614; 1988, c. 765; 1996, cc. 37, 407.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3439. Application for nonrestricted manufacturing permit; fee

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 specific place of manufacturing. Each such permit shall expire annually on a date determined by the Board in regulation.
1970, c. 650, § 54-524.40; 1972, c. 798; 1976, c. 614; 1980, c. 288; 1988, c. 765; 1996, cc. 37, 407; 2008, c. 320.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3440. Persons to whom nonrestricted permit is granted

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 public safety.
1970, c. 650, § 54-524.41; 1976, c. 614; 1988, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3441. Restricted manufacturing permit; application; fee; separate application and permit for each place of manufacturing

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 each separate place of manufacturing.
1976, c. 614, § 54-524.41:1; 1980, c. 288; 1988, c. 765; 1996, cc. 37, 407.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3442. When permit not to be granted; regulations

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 regulations in order to carry out the provisions of this section.
1976, c. 614, § 54-524.41:2; 1988, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3442.01. Registration of nonresident manufacturer; renewal

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 Board within 30 days of any substantive change in the information previously submitted.
B. The nonresident manufacturer shall at all times maintain a valid, unexpired license, permit, or registration in the state in which it is located or current registration as a manufacturer or repackager with the federal Food and Drug Administration and shall furnish proof of such upon application and at each renewal.
C. Records of prescription drugs distributed into the Commonwealth shall be maintained in such a manner that they are readily retrievable from records of shipments into other jurisdictions and shall be provided to the Board, its authorized agent, or any agent designated by the Superintendent of the Department of State Police upon request within seven days of receipt of such request.
2016, c. 221.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3442.1. Definitions

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 U.S. Food and Drug Administration and remains under investigation in a clinical trial.
"Terminal condition" means a condition caused by injury, disease, or illness from which, to a reasonable degree of medical probability, a patient cannot recover and (i) the patient's death is imminent or (ii) the patient is in a persistent vegetative state.
"Treating physician" means a physician who is providing or has previously provided medical treatment or evaluation to and has or previously had an ongoing treatment relationship with the person.
2015, cc. 655, 656.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3442.3. Expanded access to investigational drugs, biological products, or devices; cost; insurance coverage

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 manufacturer of an investigational drug, biological product, or device to make such investigational drug, biological product, or device available to such person.
B. A manufacturer that makes an investigational drug, biological product, or device available to a person who meets the criteria set forth in subsection A of § 54.1-3442.2 may provide the investigational drug, biological product, or device to the person free of charge or may require the person to pay the costs of, or the costs associated with, the manufacture of the investigational drug, biological product, or device.
C. An insurer proposing to issue individual or group accident and sickness insurance policies providing hospital, medical and surgical, or major medical coverage on an expense-incurred basis, a corporation providing individual or group accident and sickness subscription contracts, or a health maintenance organization providing a health care plan for health care services may provide coverage for costs related to treatment of a person's terminal condition with an investigational drug, biological product, or device; however, nothing in this article shall require an insurer proposing to issue individual or group accident and sickness insurance policies providing hospital, medical and surgical, or major medical coverage on an expense-incurred basis, a corporation providing individual or group accident and sickness subscription contracts, or a health maintenance organization providing a health care plan for health care services to provide coverage for costs related to treatment of a person's terminal condition with an investigational drug, biological product, or device.
2015, cc. 655, 656.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3442.4. Limitation of liability

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 from civil liability for any adverse action, condition, or other outcome resulting from the person's use of the investigational drug, biological product, or device.
B. Notwithstanding any other provision of law to the contrary, a manufacturer, distributor, administrator, health care provider as defined in § 8.01-581.1, sponsor, or physician who manufactures, supplies, distributes, administers, prescribes, or recommends an investigational drug, biological product, or device to a person who meets the criteria set forth in § 54.1-3442.2 shall be immune from suit and liability caused by, arising out of, or relating to the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescription, recommendation, administration, efficacy, or use of such investigational drug, biological product, or device made available to such person.
C. No claim or cause of action against a manufacturer, distributor, administrator, health care provider as defined in § 8.01-581.1, sponsor, or physician who manufactures, supplies, distributes, administers, prescribes, or recommends an investigational drug, biological product, or device to a person who meets the criteria set forth in § 54.1-3442.2 shall exist in any state court for claims of property, personal injury, or death caused by, arising out of, or relating to the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescription, recommendation, administration, efficacy, or use of such investigational drug, biological product, or device made available to such person.
D. No health care provider as defined in § 8.01-581.1 who recommends, prescribes, administers, distributes, or supplies an investigational drug, biological product, or device to a person who meets the criteria set forth in § 54.1-3442.2 shall be deemed to have engaged in unprofessional conduct, or shall be adversely affected in any decision relating to licensure, on such grounds.
E. Nothing in this article shall require a person to violate or act in contravention of any federal or state law as such law relates to the prescribing, dispensing, administration, or use of an investigational drug, biological product, or device.
2015, cc. 655, 656.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3442.5. (Effective until Jan 1, 2024, pursuant to Acts 2023, cc. 740, 773, cl. 2) Definitions

As used in this article:
"Botanical cannabis," "cannabis oil," "cannabis product," "designated caregiver facility," "practitioner," "registered agent," and "usable cannabis" have the same meanings as specified in § 54.1-3408.3.
"Cannabis dispensing facility" means a facility that (i) has obtained a permit from the Board pursuant to § 54.1-3442.6; (ii) is owned, at least in part, by a pharmaceutical processor; and (iii) dispenses cannabis products produced by a pharmaceutical processor to a patient, his registered agent, or, if such patient is a minor or a vulnerable adult as defined in § 18.2-369, such patient's parent or legal guardian.
"Pharmaceutical processor" means a facility that (i) has obtained a permit from the Board pursuant to § 54.1-3442.6 and (ii) cultivates Cannabis plants intended only for the production of cannabis oil, botanical cannabis, and usable cannabis, produces cannabis products, and dispenses cannabis products to a patient pursuant to a written certification, his registered agent, or, if such patient is a minor or a vulnerable adult as defined in § 18.2-369, such patient's parent or legal guardian.
2017, c. 613; 2018, cc. 246, 809; 2019, c. 690; 2020, c. 1278; 2021, Sp. Sess. I, cc. 205, 227, 228; 2022, cc. 259, 391, 392, 642; 2023, cc. 760, 780.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3442.7:1. (Effective until January 1, 2024) Packaging and labeling; corrections; records

A. Pharmaceutical processors shall comply with all packaging and labeling requirements set forth in this article and Board regulations.
B. No cannabis product shall be packaged in a container or wrapper that bears, or is otherwise labeled to bear the trademark, trade name, famous mark as defined in 15 U.S.C. § 1125, or other identifying mark, imprint, or device, or any likeness thereof, of a manufacturer, processor, packer, or distributor of a product intended for human consumption other than the manufacturer, processor, packer, or distributor that did in fact so manufacture, process, pack, or distribute such cannabis product.
C. Pharmaceutical processors may correct typographical errors made on cannabis product labels and any documents generated as the result of a wholesale transaction.
2023, cc. 760, 780.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3442.7:2. (Effective until January 1, 2024) Cannabis product registration; approval, deviation, and modification

A. A pharmaceutical processor shall register with the Board each cannabis product it manufactures. Applications for cannabis product registration shall be submitted to the Board on a form prescribed by the Board.
B. An application for cannabis product registration shall include:
1. The total tetrahydrocannabinol and total cannabidiol in such cannabis product, based on laboratory testing results for the cannabis product formulation;
2. A product name;
3. A proposed product package; and
4. A proposed product label, which shall not be required to contain an expiration date at the time of application.
C. The Board shall register all cannabis products that meet testing, labeling, and packaging standards after an application for registration is submitted. If the cannabis product fails to meet such standards or the application was deficient, the Board shall notify the applicant of the specific reasons for such failure or deficiency.
D. Within two business days of the Board's approval or deemed approval, the Board shall enter the cannabis product's national drug code number into the Prescription Monitoring Program.
E. The following cannabis product deviations from an approved cannabis product registration shall be permitted without any requirement for a new cannabis product registration or notice to the Board:
1. A deviation in the concentration of total tetrahydrocannabinol (THC) or total cannabidiol (CBD) in a cannabis product or dose thereof of up to 15 percent greater than or less than the concentration of total tetrahydrocannabinol or total cannabidiol, either or both, listed in the approved cannabis product registration; however, for a cannabis product with five milligrams or less of total THC or total CBD per dose, the total THC or total CBD concentration shall be within 0.5 milligrams of the single dose total THC or total CBD concentrations approved for that cannabis product;
2. A variation in packaging, provided that the packaging is substantially similar to the approved packaging and otherwise complies with applicable packaging requirements;
3. A deviation in labeling, including a variation made in accordance with § 54.1-3442.7:1, that reflects allowable deviations in total THC or total CBD or that makes a minor text, font, design, or similar modification, provided that the labeling is substantially similar to the approved labeling and otherwise complies with applicable labeling requirements; and
4. Any other insignificant changes.
F. A pharmaceutical processor may submit a request to modify an existing cannabis product registration in the event of a cannabis product deviation that is not set forth in subsection E. Upon receipt, the Board shall respond to such request. The Board may grant or deny the request, propose a reasonable revision, or require the pharmaceutical processor to provide additional information.
2023, cc. 760, 780.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3442.7:3. (Effective until January 1, 2024) Advertising and marketing

A. Pharmaceutical processors and cannabis dispensing facilities may (i) advertise and promote products and operations and (ii) provide educational material to practitioners, patients, and the public.
B. Pharmaceutical processors and cannabis dispensing facilities may engage in advertising or marketing that does not:
1. Include false or misleading statements;
2. Promote overconsumption;
3. Depict a person younger than 21 years of age;
4. Appeal particularly to persons younger than 21 years of age, including by using cartoons in any way;
5. Associate cannabis products with candy or similar products or depicts any images that bear a reasonable resemblance to a candy or similar product; or
6. Contain any seal, flag, crest, coat of arms, or other insignia that is likely to mislead patients or the public to believe that the cannabis product is made or endorsed by the Commonwealth.
C. All advertising and marketing by pharmaceutical processors and cannabis dispensing facilities shall (i) accurately and legibly identify the pharmaceutical processor or cannabis dispensing facility responsible for its content, (ii) include a statement that cannabis products are for use by certified patients only, and (iii) comply with Board regulations.
2023, cc. 760, 780.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3442.8. (Effective until January 1, 2024, pursuant to Acts 2023, cc. 740, 773, cl. 2) Criminal liability; exceptions

No agent or employee of a pharmaceutical processor or cannabis dispensing facility shall be prosecuted under Chapter 11 (§ 4.1-1100 et seq.) of Title 4.1 or § 18.2-248, 18.2-248.1, or 18.2-250 for possession or manufacture of marijuana or for possession, manufacture, or distribution of cannabis products, subject to any civil penalty, denied any right or privilege, or subject to any disciplinary action by a professional licensing board if such agent or employee (i) possessed or manufactured such marijuana for the purposes of producing cannabis products in accordance with the provisions of this article and Board regulations or (ii) possessed, manufactured, or distributed such cannabis products that are consistent with generally accepted cannabis industry standards in accordance with the provisions of this article and Board regulations.
2017, c. 613; 2020, cc. 764, 1278; 2021, Sp. Sess. I, cc. 227, 228, 550, 551.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3444. Controlled substances included by whatever name designated

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.
1972, c. 798, § 54-524.84:2; 1988, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3445. Placement of substance in Schedule I

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.
1972, c. 798, § 54-524.84:3; 1988, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3447. Placement of substance in Schedule II

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 substance may lead to severe psychic or physical dependence.
1972, c. 798, § 54-524.84:5; 1988, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3449. Placement of substance in Schedule III

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 substance may lead to moderate or low physical dependence or high psychological dependence.
1972, c. 798, § 54-524.84:7; 1988, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3451. Placement of substance in Schedule IV

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 to limited physical dependence or psychological dependence relative to the substances in Schedule III.
1972, c. 798, § 54-524.84:9; 1988, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3453. Placement of substance in Schedule V

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 has limited physical dependence or psychological dependence liability relative to the controlled substances listed in Schedule IV.
1972, c. 798, § 54-524.84:11; 1988, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3454. Schedule V

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 proportion to confer upon the compound, mixture, or preparation, valuable medicinal qualities other than those possessed by the narcotic drug alone:
Not more than 200 milligrams of codeine, or any of its salts, per 100 milliliters or per 100 grams;
Not more than 100 milligrams of dihydrocodeine, or any of its salts, per 100 milliliters or per 100 grams;
Not more than 100 milligrams of ethylmorphine, or any of its salts, per 100 milliliters or per 100 grams;
Not more than 2.5 milligrams of diphenoxylate and not less than 25 micrograms of atropine sulfate per dosage unit;
Not more than 100 milligrams of opium per 100 milliliters or per 100 grams;
Not more than 0.5 milligrams of difenoxin and not less than 25 micrograms of atropine sulfate per dosage unit.
The Board may except by regulation any compound, mixture, or preparation containing any depressant substance listed in subdivision 1 from the application of all or any part of this chapter and such substances so excepted may be dispensed pursuant to § 54.1-3416.
2. Unless specifically excepted or listed in another schedule, any material, compound, mixture, or preparation that contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers, and salts of isomers:
Pyrovalerone.
3. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation that contains any quantity of the following substances having a depressant effect on the central nervous system, including its salts:
Brivaracetam ((2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide) (also referred to as BRV; UCB-34714; Briviact);
Ezogabine [N-[2-amino-4-(4-fluorobenzylamino)-phenyl]-carbamic acid ethyl ester]-2779;
Gabapentin [1-(aminomethyl)cyclohexaneacetic acid];
Lacosamide [(R)-2-acetoamido-N-benzyl-3-methoxy-propionamide];
Lasmiditan [2,4,6-trifluoro-N-(6-(1-methylpiperidine-4-carbonyl)pyridine-2-yl-benzamide];
Pregabalin [(S)-3-(aminomethyl)-5-methylhexanoic acid].
1972, c. 798, § 54-524.84:12; 1976, c. 614; 1977, c. 302; 1979, c. 387; 1984, c. 186; 1986, c. 463; 1988, c. 765; 1992, c. 737; 1994, c. 763; 2003, c. 640; 2006, c. 346; 2010, c. 423; 2012, c. 541; 2017, c. 612; 2019, c. 214; 2022, cc. 114, 115.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3455. Schedule VI

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 included in Schedules I, II, III, IV or V, or device, which because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not generally recognized among experts qualified by scientific training and experience to evaluate its safety and efficacy as safe for use except by or under the supervision of a practitioner licensed to prescribe or administer such drug or device.
3. Any drug, not included in Schedules I, II, III, IV or V, required by federal law to bear on its label prior to dispensing, at a minimum, the symbol "Rx only," or which bears the legend "Caution: Federal Law Prohibits Dispensing Without Prescription" or "Caution: Federal Law Restricts This Drug To Use By Or On The Order Of A Veterinarian" or any device which bears the legend "Caution: Federal Law Restricts This Device To Sales By Or On The Order Of A _______________." (The blank should be completed with the word "Physician," "Dentist," "Veterinarian," or with the professional designation of any other practitioner licensed to use or order such device.)
1972, c. 798, § 54-524.84:13; 1976, c. 614; 1977, c. 302; 1988, c. 765; 1999, c. 605.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3456. Controlled substance analog

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 class of drugs which it imitates.
1987, c. 447, § 54-524.84:14; 1988, c. 765; 2014, cc. 674, 719.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3456.1. Drugs of concern

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 of concern shall be reported to the Department of Health Professions and shall be subject to reporting requirements for the Prescription Monitoring Program established pursuant to Chapter 25.2 (§ 54.1-2519 et seq.).
2014, c. 664; 2017, c. 181; 2019, c. 214.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3458. Violations

A. Any person who violates any of the provisions of § 54.1-3457 shall be guilty of a Class 2 misdemeanor.
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 containing the name and address of, the person residing in this Commonwealth from whom he received in good faith the article, to the effect that such article is not adulterated or misbranded within the meaning of this chapter.
C. No publisher, radio-broadcast licensee, or agency or medium for the dissemination of an advertisement, except the manufacturer, packer, distributor, or seller of the article to which a false advertisement relates, shall be liable under this section for the dissemination of such false advertisement, unless he has refused, on the request of the Board, to furnish the Board the name and post-office address of the manufacturer, packer, distributor, seller, or advertising agency, residing in this Commonwealth who caused him to disseminate such advertisement.
1970, c. 650, § 54-524.87; 1988, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3459. Tagging of adulterated or misbranded drugs, devices, or cosmetics; condemnation; destruction; expenses

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 such article a tag or other appropriate marking, giving notice that such article is, or is suspected of being, adulterated or misbranded or in violation of § 54.1-3457 and has been detained. The tag shall also warn all persons not to remove or dispose of such article by sale or otherwise until permission for removal or disposal is given by an authorized agent or the court. It shall be unlawful for any person to remove or dispose of such detained article by sale or otherwise without permission.
B. When an article is adulterated or misbranded or is in violation of § 54.1-3421, the Board may petition the circuit court in whose jurisdiction the article is detained for condemnation of such article. When an authorized agent finds that an article which has been detained is not adulterated or misbranded, or in violation of § 54.1-3421, he shall remove the tag or other marking.
C. If the court finds that a detained article is adulterated or misbranded, or in violation of § 54.1-3421, such article shall, after entry of the decree, be destroyed at the expense of the claimant, under the supervision of an authorized agent, and all court costs and fees, and storage and other proper expenses, shall be levied against the claimant or his agent. When the adulteration or misbranding can be corrected by proper labeling or processing of the article, the court shall order the article to be properly labeled or processed. The expense of the supervision shall be paid by the claimant. The article shall be returned to the claimant and the bond shall be discharged on the representation to the court by the Board that the article is no longer in violation of this chapter, and that the expenses of such supervision have been paid.
1970, c. 650, § 54-524.88; 1988, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3460. Poisonous or deleterious substance, or color additive

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 use or intended use of such substance conforms to the terms prescribed by regulation. While such regulations relating to such substance are in effect, a drug or cosmetic shall not, by reason of bearing or containing such substance in accordance with the regulations, be considered adulterated.
1970, c. 650, § 54-524.91; 1988, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3461. Adulterated drug or device

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 has been rendered injurious to health;
3. If it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter;
4. If it is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;
5. If it is a drug and it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of the federal act or § 54.1-3460; or
6. It is a color additive, the intended use of which in or on drugs is for purposes of coloring only, and is unsafe within the meaning of the federal act or § 54.1-3460.
B. A drug or device shall be deemed to be adulterated if it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. Such determination of strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, or in the absence of or inadequacy of such tests or methods of assay, those prescribed under authority of the federal act. No drug defined in an official compendium shall be deemed to be adulterated under this subsection because it differs from the standard of strength, quality, or purity set forth in such compendium, if the difference in strength, quality, or purity from such standard is plainly stated on its label.
Whenever a drug is recognized in both the United States Pharmacopoeia National Formulary and the Homeopathic Pharmacopoeia of the United States it shall be subject to the requirements of the United States Pharmacopoeia National Formulary unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia National Formulary.
C. A drug or device shall be deemed to be adulterated if it is not subject to the provisions of subsection B of this section and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
D. A drug or device shall be deemed to be adulterated if it is a drug and any substance has been (i) mixed or packed with it so as to reduce its quality or strength or (ii) substituted wholly or in part for it.
Code 1950, § 54-461; 1970, c. 650, § 54-524.92; 1988, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3463. Exemption of drugs dispensed by filling or refilling prescription

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 address of the dispenser, the serial number and date of the prescription or of its filling, the name of the prescriber and the name of the patient, and the directions for use and cautionary statements, if any, contained in such prescription.
B. This section shall not be construed to relieve any person from any requirement prescribed by or under authority of law with respect to drugs now included or which may hereafter be included within the classifications of narcotic drugs or marijuana as defined in the applicable federal and state laws relating to narcotic drugs and marijuana.
1970, c. 650, § 54-524.94; 1988, c. 765; 1996, c. 408.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3464. Adulterated cosmetics

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 usual. This provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon: "Caution -- This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness," and the labeling of which bears adequate directions for such preliminary testing. For the purpose of this subdivision and subdivision 5, the term "hair dye" shall not include eyelash or eyebrow dyes;
2. If it consists in whole or in part of any filthy, putrid, or decomposed substance;
3. If it has been produced, prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;
4. If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;
5. If it is not a hair dye, and it is or it bears or contains a color additive which is unsafe within the meaning of the federal act or § 54.1-3460.
Code 1950, § 54-462; 1970, c. 650, § 54-524.96; 1988, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3465. Misbranded cosmetics

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 of the contents in terms of weight, measure, or numerical count. However, reasonable variations shall be permitted, and exemptions for small packages shall be established by the Board;
3. If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness, as compared with other words, statements, designs, or devices, in the labeling, and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
4. If its container is so made, formed or filled as to be misleading;
5. If it is a color additive, unless its packaging and labeling are in conformity with packaging and labeling requirements applicable to such color additive under the provisions of the federal act. This subdivision shall not apply to packages of color additives which, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes.
A cosmetic which is, in accordance with the practice of the trade, to be processed, labeled or repacked in substantial quantities at an establishment other than the establishment where it was originally processed or packed, is exempted from the affirmative labeling requirements of this chapter while it is in transit in commerce from the one establishment to the other, if such transit is made in good faith for such completion purposes only; but it is otherwise subject to all applicable provisions of this chapter.
Code 1950, § 54-466; 1970, c. 650, § 54-524.97; 1988, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3467. Distribution of hypodermic needles or syringes, gelatin capsules, quinine or any of its salts

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 section shall prohibit the dispensing or distributing of hypodermic needles and syringes by persons authorized by the State Health Commissioner pursuant to a comprehensive harm reduction program established pursuant to § 32.1-45.4 who are acting in accordance with the standards and protocols of such program for the duration of the declared public health emergency.
C. Nothing in this section shall prohibit the dispensing or distributing of hypodermic needles and syringes by persons authorized to dispense naloxone in accordance with the provisions of subsection Y of § 54.1-3408 and who, in conjunction with such dispensing of naloxone, dispenses or distributes hypodermic needles and syringes. Nothing in this section shall prohibit the dispensing of hypodermic needles and syringes for the administration of prescribed drugs by prescribers licensed to dispense Schedule VI controlled substances at a nonprofit facility pursuant to § 54.1-3304.1.
D. Notwithstanding the provisions of subsection A, nothing in this section shall prohibit the distribution of hypodermic needles that are designed to be used with a reusable injector pen for the administration of insulin.
1971, Ex. Sess., cc. 210, 245; 1988, c. 765; 2017, c. 183; 2018, c. 97; 2020, cc. 609, 610; 2023, cc. 142, 143.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3468. Conditions to dispensing device, item, or substance; records

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. Require the person requesting such item, device or substance to furnish written legitimate purposes for which such item, device or substance is being purchased, except in cases of telephone orders for such item, device or substance from customers of known good standing;
3. At the time of dispensing, make and keep a record showing the date of dispensing, the name and quantity of the device, item or substance, the price at which it was sold, the name and address of the person to whom the device, item or substance was dispensed, the reason for its purchase and enter his initials thereon.
No such devices, substances or items shall be sold or distributed to persons under the age of sixteen years except by a physician for legitimate purposes or upon his prescription. Records shall be maintained pursuant to this chapter and the Board's regulations and shall be made available for inspection to any law-enforcement officer or agent of the Board. Persons violating the provisions of this section shall be guilty of a Class 1 misdemeanor.
1971, Ex. Sess., cc. 210, 245; 1988, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3469. Storage, usage, and disposition of controlled paraphernalia

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 for reuse for any purposes other than those for which they were lawfully obtained. Any person who permits or causes, directly or indirectly, such controlled paraphernalia to be used for any other purpose than that for which it was lawfully obtained shall be guilty of a Class 1 misdemeanor.
1971, Ex. Sess., cc. 210, 245; 1988, c. 765.
2023 Code of Virginia › Title 54.1 - Professions and Occupations › Chapter 34 - Drug Control Act › § 54.1-3470. Obtaining controlled paraphernalia by fraud, etc.

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 information from, or willfully make a false statement in obtaining or attempting to obtain any of the instruments or substances referred to in § 54.1-3467.
C. No person shall, for the purpose of obtaining any such instrument or substance, falsely claim to be a manufacturer, wholesaler, pharmacist, practitioner of the healing arts, funeral director, embalmer or veterinarian.
Persons violating the provisions of this section shall be guilty of a Class 1 misdemeanor.
1971, Ex. Sess., cc. 210, 245; 1988, c. 765.