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.
Structure Code of Virginia
Title 54.1 - Professions and Occupations
§ 54.1-3403. Chapter not applicable to economic poisons
§ 54.1-3405. Access to and copies of records; inspections
§ 54.1-3406. Records confidential; disclosure of information about violations of federal law
§ 54.1-3407. Analysis of controlled substances
§ 54.1-3408. Professional use by practitioners
§ 54.1-3408.01. Requirements for prescriptions
§ 54.1-3408.02. Transmission of prescriptions
§ 54.1-3408.03. Dispensing of therapeutically equivalent drug product permitted
§ 54.1-3408.04. Dispensing of interchangeable biosimilars permitted
§ 54.1-3408.05. Use of FDA-approved substance upon publication of final rule
§ 54.1-3408.1. Prescription in excess of recommended dosage in certain cases
§ 54.1-3408.3. Certification for use of cannabis oil for treatment
§ 54.1-3408.5. Epinephrine required in certain public places
§ 54.1-3409. Professional use by veterinarians
§ 54.1-3410. When pharmacist may sell and dispense drugs
§ 54.1-3410.1. Requirements for radiopharmaceuticals
§ 54.1-3411. When prescriptions may be refilled
§ 54.1-3411.1. Prohibition on returns, exchanges, or re-dispensing of drugs; exceptions
§ 54.1-3411.2. Prescription drug disposal programs
§ 54.1-3411.2:1. Guidelines for disposal of unused drugs
§ 54.1-3412. Date of dispensing; initials of pharmacist; automated data processing system
§ 54.1-3413. Manufacturing and administering Schedule I drugs
§ 54.1-3414. Official orders for Schedule II drugs
§ 54.1-3415. Distribution of drugs in Schedules II through VI by manufacturers and wholesalers
§ 54.1-3415.1. Delivery of medical devices on behalf of a medical equipment supplier
§ 54.1-3416. No prescription for preparations listed pursuant to Schedule V
§ 54.1-3417. Disposing of stocks of Schedules II through V drugs
§ 54.1-3418. Sale of aqueous or oleaginous solutions
§ 54.1-3419. Dispensing of insulin preparations
§ 54.1-3420. Distribution of certain drugs; written request or confirmation of receipt
§ 54.1-3420.1. Identification required for filling prescriptions
§ 54.1-3420.2. Delivery of prescription drug order
§ 54.1-3426. Regulations for special packaging
§ 54.1-3427. Dispensing drugs without safety closure container
§ 54.1-3428. Dissemination of information
§ 54.1-3429. Revocation of permit issued to manufacturer, wholesaler or distributor
§ 54.1-3430. Display of permit; permits nontransferable; renewal
§ 54.1-3431. Admission into evidence of certain certificates of analysis
§ 54.1-3432. Supervision by pharmacist
§ 54.1-3433. Certain advertising and signs unlawful
§ 54.1-3434. Permit to conduct pharmacy
§ 54.1-3434.01. Notice of pharmacy closing; change of ownership; penalty
§ 54.1-3434.02. Automated drug dispensing systems
§ 54.1-3434.03. Continuous quality improvement program
§ 54.1-3434.04. Automatic review of certain case decisions
§ 54.1-3434.05. Permit to act as an outsourcing facility
§ 54.1-3434.1. Nonresident pharmacies to register with Board
§ 54.1-3434.2. Permit to be issued
§ 54.1-3434.3. Denial, revocation, suspension of registration, summary proceedings
§ 54.1-3434.4. Prohibited acts
§ 54.1-3434.5. Nonresident outsourcing facilities to register with the Board
§ 54.1-3435. License to act as wholesale distributor; renewal; fee
§ 54.1-3435.01. Registration of nonresident wholesale distributors; renewal; fee
§ 54.1-3435.02. Certain permitted pharmacies and medical equipment suppliers exempted
§ 54.1-3435.2. Permit to act as medical equipment supplier; storage; limitation; regulations
§ 54.1-3435.3. Inspection and audit
§ 54.1-3435.3:1. Registration of nonresident medical equipment suppliers; renewal; fee
§ 54.1-3435.4. Permit to act as warehouser; regulations
§ 54.1-3435.4:01. Registration to act as a nonresident warehouser; regulations
§ 54.1-3435.4:1. Permitting of third-party logistics provider; renewal
§ 54.1-3435.4:2. Registration of nonresident third-party logistics provider; renewal
§ 54.1-3436.1. Prescription drug price transparency
§ 54.1-3437. Permit to manufacture drugs
§ 54.1-3437.1. Limited permit for repackaging drugs
§ 54.1-3438. Manufacturing, etc., of drugs or proprietary medicines, to be supervised by pharmacist
§ 54.1-3439. Application for nonrestricted manufacturing permit; fee
§ 54.1-3440. Persons to whom nonrestricted permit is granted
§ 54.1-3442. When permit not to be granted; regulations
§ 54.1-3442.01. Registration of nonresident manufacturer; renewal
§ 54.1-3442.02. Prescription drug price transparency
§ 54.1-3442.4. Limitation of liability
§ 54.1-3442.6. Permit to operate pharmaceutical processor or cannabis dispensing facility
§ 54.1-3442.7. Dispensing cannabis products; report
§ 54.1-3442.8. Criminal liability; exceptions
§ 54.1-3443. Board to administer article
§ 54.1-3444. Controlled substances included by whatever name designated
§ 54.1-3445. Placement of substance in Schedule I
§ 54.1-3447. Placement of substance in Schedule II
§ 54.1-3449. Placement of substance in Schedule III
§ 54.1-3451. Placement of substance in Schedule IV
§ 54.1-3453. Placement of substance in Schedule V
§ 54.1-3456. Controlled substance analog
§ 54.1-3456.1. Drugs of concern
§ 54.1-3460. Poisonous or deleterious substance, or color additive
§ 54.1-3461. Adulterated drug or device
§ 54.1-3462. Misbranded drug or device
§ 54.1-3463. Exemption of drugs dispensed by filling or refilling prescription
§ 54.1-3464. Adulterated cosmetics
§ 54.1-3465. Misbranded cosmetics
§ 54.1-3468. Conditions to dispensing device, item, or substance; records
§ 54.1-3469. Storage, usage, and disposition of controlled paraphernalia
§ 54.1-3470. Obtaining controlled paraphernalia by fraud, etc.
§ 54.1-3471. Issuance of permits to certain persons other than registered pharmacists