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, nonresident manufacturer permit, or nonresident warehouser registration as provided for in § 54.1-3316 or the following:
1. Any conviction of the applicant, licensee, or registrant under federal or state laws relating to controlled substances, including, but not limited to, drug samples and wholesale or retail prescription drug distribution;
2. Violations of licensing requirements under previously held licenses;
3. Failure to maintain and make available to the Board or to federal regulatory officials those records required to be maintained by wholesale distributors of prescription drugs; or
4. Violations of the minimum requirements for qualifications, personnel, storage, and handling of prescription drugs and maintenance of prescription drug records as set forth in the federal Drug Supply Chain Security Act of 2013, Title II of P. L. 113-54, and the requirements of Chapter 21 of the Code of Federal Regulations.
B. Wholesale drug distributors, nonresident wholesale drug distributors, third-party logistics providers, nonresident third-party logistics providers, manufacturers, nonresident manufacturers, and nonresident warehousers 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. Such agents shall be required to show appropriate identification prior to being permitted access to wholesale drug distributors' premises and delivery vehicles.
1992, c. 737; 1994, c. 300; 2007, c. 662; 2016, c. 221; 2018, c. 96.
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