The Drug Control Act

Virginia · 54.1 · §§ 54.1-3400 to 54.1-3472 · 127 sections

Overview

The Drug Control Act governs the manufacture, distribution, prescribing, and dispensing of drugs and controlled substances, sorting regulated substances into schedules that carry different levels of control. It defines who may prescribe, administer, compound, and dispense — practitioners, veterinarians, pharmacists, manufacturers, wholesalers, and suppliers — and imposes duties on each, including inventory and dispensing records subject to inspection but otherwise confidential, requirements for the form, transmission, labeling, and refilling of prescriptions, identification checks, and mandatory reporting of certain dispensing activity backed by penalties. It also permits substitution of therapeutically equivalent drug products and interchangeable biosimilars, limits the return or re-dispensing of drugs already released, and provides for the disposal of unused and surplus stocks.

Editorial summary generated from the text of this act. It is not part of the statute — read the sections below for the operative language.

In the courts

Sections of this act have been cited in 36 court decisions.

Most-cited authority: 254 F.3d 488 - United States v. Cephas

Sections covered

Va. Code Ann. § 54.1-3400Citation3 cites
Va. Code Ann. § 54.1-3401Definitions8 cites
Va. Code Ann. § 54.1-3401.1Repealed
Va. Code Ann. § 54.1-3402Repealed
Va. Code Ann. § 54.1-3403Chapter not applicable to economic poisons
Va. Code Ann. § 54.1-3404Inventories of controlled substances required of certain persons; contents and form of record
Va. Code Ann. § 54.1-3405Access to and copies of records; inspections
Va. Code Ann. § 54.1-3406Records confidential; disclosure of information about violations of federal law
Va. Code Ann. § 54.1-3407Analysis of controlled substances
Va. Code Ann. § 54.1-3408Professional use by practitioners1 cite
Va. Code Ann. § 54.1-3408.01Requirements for prescriptions
Va. Code Ann. § 54.1-3408.02Transmission of prescriptions
Va. Code Ann. § 54.1-3408.03Dispensing of therapeutically equivalent drug product permitted
Va. Code Ann. § 54.1-3408.04Dispensing of interchangeable biosimilars permitted
Va. Code Ann. § 54.1-3408.05Use of FDA-approved substance upon publication of final rule
Va. Code Ann. § 54.1-3408.1Prescription in excess of recommended dosage in certain cases
Va. Code Ann. § 54.1-3408.2Failure to report administration or dispensing of or prescription for controlled substances; report required; penalty1 cite
Va. Code Ann. § 54.1-3408.3Certification for use of cannabis for treatment
Va. Code Ann. § 54.1-3408.4Expired
Va. Code Ann. § 54.1-3408.5Epinephrine required in certain places of public accommodation
Va. Code Ann. § 54.1-3409Professional use by veterinarians
Va. Code Ann. § 54.1-3410When pharmacist may sell and dispense drugs
Va. Code Ann. § 54.1-3410.1Requirements for radiopharmaceuticals
Va. Code Ann. § 54.1-3410.2Compounding; pharmacists' authority to compound under certain conditions; labeling and record maintenance requirements1 cite
Va. Code Ann. § 54.1-3410.3Accessible prescription labels
Va. Code Ann. § 54.1-3411When prescriptions may be refilled
Va. Code Ann. § 54.1-3411.1Prohibition on returns, exchanges, or re-dispensing of drugs; exceptions
Va. Code Ann. § 54.1-3411.2Prescription drug disposal programs
Va. Code Ann. § 54.1-3411.2:1Guidelines for disposal of unused drugs
Va. Code Ann. § 54.1-3412Date of dispensing; initials of pharmacist; automated data processing system
Va. Code Ann. § 54.1-3413Manufacturing and administering Schedule I drugs
Va. Code Ann. § 54.1-3414Official orders for Schedule II drugs
Va. Code Ann. § 54.1-3415Distribution of drugs in Schedules II through VI by manufacturers and wholesalers
Va. Code Ann. § 54.1-3415.1Delivery of medical devices on behalf of a medical equipment supplier
Va. Code Ann. § 54.1-3416No prescription for preparations listed pursuant to Schedule V
Va. Code Ann. § 54.1-3417Disposing of stocks of Schedules II through V drugs
Va. Code Ann. § 54.1-3418Sale of aqueous or oleaginous solutions
Va. Code Ann. § 54.1-3419Dispensing of insulin preparations
Va. Code Ann. § 54.1-3420Distribution of certain drugs; written request or confirmation of receipt
Va. Code Ann. § 54.1-3420.1Identification required for filling prescriptions
Va. Code Ann. § 54.1-3420.2Delivery of prescription drug order
Va. Code Ann. § 54.1-3420.3Prohibition on refusing to fill prescription from telemedicine provider
Va. Code Ann. § 54.1-3421New drugs
Va. Code Ann. § 54.1-3422Controlled substances registration certificate required in addition to other requirements; exemptions
Va. Code Ann. § 54.1-3423Board to issue registration unless inconsistent with public interest; authorization to conduct research; application and fees
Va. Code Ann. § 54.1-3424Suspension 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
Va. Code Ann. § 54.1-3425Repealed
Va. Code Ann. § 54.1-3426Regulations for special packaging
Va. Code Ann. § 54.1-3427Dispensing drugs without safety closure container
Va. Code Ann. § 54.1-3428Dissemination of information
Va. Code Ann. § 54.1-3429Revocation of permit issued to manufacturer, wholesaler or distributor
Va. Code Ann. § 54.1-3430Display of permit; permits nontransferable; renewal
Va. Code Ann. § 54.1-3431Admission into evidence of certain certificates of analysis
Va. Code Ann. § 54.1-3432Supervision by pharmacist
Va. Code Ann. § 54.1-3433Certain advertising and signs unlawful1 cite
Va. Code Ann. § 54.1-3434Permit to conduct pharmacy
Va. Code Ann. § 54.1-3434.01Notice of pharmacy closing; change of ownership; penalty
Va. Code Ann. § 54.1-3434.02Automated drug dispensing systems and remote dispensing systems
Va. Code Ann. § 54.1-3434.03Continuous quality improvement program
Va. Code Ann. § 54.1-3434.04Automatic review of certain case decisions
Va. Code Ann. § 54.1-3434.05Permit to act as an outsourcing facility
Va. Code Ann. § 54.1-3434.1Nonresident pharmacies to register with Board1 cite
Va. Code Ann. § 54.1-3434.2Permit to be issued
Va. Code Ann. § 54.1-3434.3Denial, revocation, suspension of registration, summary proceedings
Va. Code Ann. § 54.1-3434.4Prohibited acts
Va. Code Ann. § 54.1-3434.5Nonresident outsourcing facilities to register with the Board
Va. Code Ann. § 54.1-3435License to act as wholesale distributor; renewal; fee
Va. Code Ann. § 54.1-3435.01Registration of nonresident wholesale distributors; renewal; fee
Va. Code Ann. § 54.1-3435.02Certain permitted pharmacies and medical equipment suppliers exempted
Va. Code Ann. § 54.1-3435.1Denial, revocation, and suspension of license, permit, or registration of certain entities
Va. Code Ann. § 54.1-3435.2Permit to act as medical equipment supplier; storage; limitation; regulations
Va. Code Ann. § 54.1-3435.3Inspection and audit
Va. Code Ann. § 54.1-3435.3:1Registration of nonresident medical equipment suppliers; renewal; fee
Va. Code Ann. § 54.1-3435.4Permit to act as warehouser; regulations
Va. Code Ann. § 54.1-3435.4:01Registration to act as a nonresident warehouser; regulations
Va. Code Ann. § 54.1-3435.4:1Permitting of third-party logistics provider; renewal
Va. Code Ann. § 54.1-3435.4:2Registration of nonresident third-party logistics provider; renewal
Va. Code Ann. § 54.1-3435.5Repealed
Va. Code Ann. § 54.1-3436Repealed
Va. Code Ann. § 54.1-3436.1Prescription drug price transparency
Va. Code Ann. § 54.1-3437Permit to manufacture drugs
Va. Code Ann. § 54.1-3437.1Limited permit for repackaging drugs
Va. Code Ann. § 54.1-3438Manufacturing, etc., of drugs or proprietary medicines, to be supervised by pharmacist
Va. Code Ann. § 54.1-3439Application for nonrestricted manufacturing permit; fee
Va. Code Ann. § 54.1-3440Persons to whom nonrestricted permit is granted
Va. Code Ann. § 54.1-3441Restricted manufacturing permit; application; fee; separate application and permit for each place of manufacturing
Va. Code Ann. § 54.1-3442When permit not to be granted; regulations
Va. Code Ann. § 54.1-3442.01Registration of nonresident manufacturer; renewal
Va. Code Ann. § 54.1-3442.02Prescription drug price transparency
Va. Code Ann. § 54.1-3442.1Definitions
Va. Code Ann. § 54.1-3442.2Eligibility for expanded access to investigational drugs, biological products, and devices; written, informed consent to treatment
Va. Code Ann. § 54.1-3442.3Expanded access to investigational drugs, biological products, or devices; cost; insurance coverage
Va. Code Ann. § 54.1-3442.4Limitation of liability
Va. Code Ann. § 54.1-3442.5Repealed
Va. Code Ann. § 54.1-3442.7:1Expired
Va. Code Ann. § 54.1-3442.8Repealed
Va. Code Ann. § 54.1-3443Board to administer article1 cite
Va. Code Ann. § 54.1-3444Controlled substances included by whatever name designated
Va. Code Ann. § 54.1-3445Placement of substance in Schedule I2 cites
Va. Code Ann. § 54.1-3446Schedule I8 cites
Va. Code Ann. § 54.1-3447Placement of substance in Schedule II
Va. Code Ann. § 54.1-3448Schedule II6 cites
Va. Code Ann. § 54.1-3449Placement of substance in Schedule III
Va. Code Ann. § 54.1-3450Schedule III
Va. Code Ann. § 54.1-3451Placement of substance in Schedule IV
Va. Code Ann. § 54.1-3452Schedule IV
Va. Code Ann. § 54.1-3453Placement of substance in Schedule V
Va. Code Ann. § 54.1-3454Schedule V
Va. Code Ann. § 54.1-3455Schedule VI1 cite
Va. Code Ann. § 54.1-3456Controlled substance analog
Va. Code Ann. § 54.1-3456.1Drugs of concern
Va. Code Ann. § 54.1-3457Prohibited acts1 cite
Va. Code Ann. § 54.1-3458Violations1 cite
Va. Code Ann. § 54.1-3459Tagging of adulterated or misbranded drugs, devices, or cosmetics; condemnation; destruction; expenses
Va. Code Ann. § 54.1-3460Poisonous or deleterious substance, or color additive
Va. Code Ann. § 54.1-3461Adulterated drug or device
Va. Code Ann. § 54.1-3462Misbranded drug or device
Va. Code Ann. § 54.1-3463Exemption of drugs dispensed by filling or refilling prescription
Va. Code Ann. § 54.1-3464Adulterated cosmetics
Va. Code Ann. § 54.1-3465Misbranded cosmetics
Va. Code Ann. § 54.1-3466Possession or distribution of controlled paraphernalia; definition of controlled paraphernalia; evidence; exceptions
Va. Code Ann. § 54.1-3467Distribution of hypodermic needles or syringes, gelatin capsules, quinine or any of its salts
Va. Code Ann. § 54.1-3468Conditions to dispensing device, item, or substance; records
Va. Code Ann. § 54.1-3469Storage, usage, and disposition of controlled paraphernalia
Va. Code Ann. § 54.1-3470Obtaining controlled paraphernalia by fraud, etc
Va. Code Ann. § 54.1-3471Issuance of permits to certain persons other than registered pharmacists
Va. Code Ann. § 54.1-3472Article inapplicable to certain persons

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