Virginia Code 54.1-3434.05: Permit to act as an outsourcing facility
A. No person shall act as an outsourcing facility without first obtaining a permit from the Board.
Terms Used In Virginia Code 54.1-3434.05
- Agent: means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser. See Virginia Code 54.1-3401
- Board: means the Board of Pharmacy. See Virginia Code 54.1-3401
- Compounding: means the combining of two or more ingredients to fabricate such ingredients into a single preparation and includes the mixing, assembling, packaging, or labeling of a drug or device (i) by a pharmacist, or within a permitted pharmacy, pursuant to a valid prescription issued for a medicinal or therapeutic purpose in the context of a bona fide practitioner-patient-pharmacist relationship, or in expectation of receiving a valid prescription based on observed historical patterns of prescribing and dispensing; (ii) by a practitioner of medicine, osteopathy, podiatry, dentistry, or veterinary medicine as an incident to his administering or dispensing, if authorized to dispense, a controlled substance in the course of his professional practice; or (iii) for the purpose of, or as incident to, research, teaching, or chemical analysis and not for sale or for dispensing. See Virginia Code 54.1-3401
- Drug: means (i) articles or substances recognized in the official United States Pharmacopoeia National Formulary or official Homeopathic Pharmacopoeia of the United States, or any supplement to any of them; (ii) articles or substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals; (iii) articles or substances, other than food, intended to affect the structure or any function of the body of man or animals; (iv) articles or substances intended for use as a component of any article specified in clause (i), (ii), or (iii); or (v) a biological product. See Virginia Code 54.1-3401
- Outsourcing facility: means a facility that is engaged in the compounding of sterile drugs and is currently registered as an outsourcing facility with the U. See Virginia Code 54.1-3401
- Person: means both the plural and singular, as the case demands, and includes an individual, partnership, corporation, association, governmental agency, trust, or other institution or entity. See Virginia Code 54.1-3401
- Prescription: means an order for drugs or medical supplies, written or signed or transmitted by word of mouth, telephone, telegraph, or other means of communication to a pharmacist by a duly licensed physician, dentist, veterinarian, or other practitioner authorized by law to prescribe and administer such drugs or medical supplies. See Virginia Code 54.1-3401
- State: when applied to a part of the United States, includes any of the 50 states, the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Northern Mariana Islands, and the United States Virgin Islands. See Virginia Code 1-245
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.