A. No person shall act as an outsourcing facility without first obtaining a permit from the Board.
B. Applications for a permit to act as an outsourcing facility shall be made on a form provided by the Board and signed by a pharmacist who will be in full and actual charge of the outsourcing facility and who will be fully engaged in the compounding performed at the location designated on the application. Such application shall be accompanied by a fee determined by the Board in regulation. All permits shall expire annually on a date determined by the Board in regulation. No permit shall be issued or renewed for an outsourcing facility unless the facility can demonstrate compliance with all applicable federal and state laws and regulations governing outsourcing facilities.
C. As a prerequisite to obtaining or renewing a permit from the Board, the outsourcing facility shall (i) register as an outsourcing facility with the U.S. Secretary of Health and Human Services in accordance with 21 U.S.C. § 353b and (ii) submit a copy of a current inspection report resulting from an inspection conducted by the U.S. Food and Drug Administration that indicates compliance with the requirements of state and federal law and regulations, including all applicable guidance documents and Current Good Manufacturing Practices published by the U.S. Food and Drug Administration.
The inspection report required pursuant to clause (ii) shall be deemed current for the purposes of this section if the inspection was conducted (a) no more than one year prior to the date of submission of an application for a permit to the Board or (b) no more than two years prior to the date of submission of an application for renewal of a permit to the Board. However, if the outsourcing facility has not been inspected by the U.S. Food and Drug Administration within the required period, the Board may accept an inspection report or other documentation from another entity that is satisfactory to the Board, or the Board may cause an inspection to be conducted by its duly authorized agent and may charge an inspection fee in an amount sufficient to cover the costs of the inspection.
D. Every outsourcing facility shall compound in compliance with the requirements of state and federal law and regulations except § 54.1-3410.2, to include all applicable guidance documents and Current Good Manufacturing Practices published by the U.S. Food and Drug Administration.
E. An outsourcing facility shall not engage in compounding of drug products to be dispensed pursuant to a valid prescription for a specific patient without first obtaining a permit to operate a pharmacy.
2015, c. 300.
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