Virginia Code 54.1-3307.2: Approval of innovative programs.
A. Any person who proposes to use a process or procedure related to the dispensing of drugs or devices or to the practice of pharmacy not specifically authorized by Chapter 33 (§ 54.1-3300 et seq.) of this title or by a regulation of the Board of Pharmacy may apply to the Board for approval to use such process or procedure. The application under this section may only include new processes or procedures, within the current scope of the practice of pharmacy, that relate to the form or format of prescriptions, the manner of transmitting prescriptions or prescription information, the manner of required recordkeeping, the use of unlicensed ancillary personnel in the dispensing process, and the use of new technologies in the dispensing process. The authority granted the Board under this section shall not authorize expansion of the current scope of practice for pharmacists and shall not interfere with the requirement that pharmacists only dispense drugs in accordance with instructions from a prescriber, as defined in § 54.1-3401.
Terms Used In Virginia Code 54.1-3307.2
- Board: means the Board of Pharmacy. See Virginia Code 54.1-3300
- Conference committee: A temporary, ad hoc panel composed of conferees from both chamber of a legislature which is formed for the purpose of reconciling differences in legislation that has passed both chambers. Conference committees are usually convened to resolve bicameral differences on major and controversial legislation.
- Dispense: means to deliver a drug to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing and administering, packaging, labeling, or compounding necessary to prepare the substance for delivery. See Virginia Code 54.1-3300
- Person: includes any individual, corporation, partnership, association, cooperative, limited liability company, trust, joint venture, government, political subdivision, or any other legal or commercial entity and any successor, representative, agent, agency, or instrumentality thereof. See Virginia Code 1-230
- Pharmacy: means every establishment or institution in which drugs, medicines, or medicinal chemicals are dispensed or offered for sale, or a sign is displayed bearing the word or words "pharmacist" "pharmacy" "apothecary" "drugstore" "druggist" "drugs" "medicine store" "drug sundries" "prescriptions filled" or any similar words intended to indicate that the practice of pharmacy is being conducted. See Virginia Code 54.1-3300
- Practice of pharmacy: means the personal health service that is concerned with the art and science of selecting, procuring, recommending, administering, preparing, compounding, packaging, and dispensing of drugs, medicines, and devices used in the diagnosis, treatment, or prevention of disease, whether compounded or dispensed on a prescription or otherwise legally dispensed or distributed, and shall include (i) the proper and safe storage and distribution of drugs; (ii) the maintenance of proper records; (iii) the responsibility of providing information concerning drugs and medicines and their therapeutic values and uses in the treatment and prevention of disease; (iv) the management of patient care under the terms of a collaborative agreement as defined in this section; and (v) the initiating of treatment with or dispensing or administering of certain drugs, devices, or controlled paraphernalia in accordance with the provisions of § Virginia Code 54.1-3300
- Process: includes subpoenas, the summons and complaint in a civil action, and process in statutory actions. See Virginia Code 1-237
B. The application to the Board shall address safety to the public regarding the new process or procedure, any potential benefit to the public, promotion of scientific or technical advances in the practice of pharmacy, compliance with prescriber’s instructions for any drug dispensed, any impact the new process may have on the potential for diversion of drugs, maintenance in the integrity of and public confidence in the profession of pharmacy and of the drugs dispensed, impact on cost to the public and within the health care industry, means of monitoring the new process or procedure for any negative outcomes or other problems, and the reporting of such outcomes to the Board.
C. An informal conference committee, composed of not less than two members of the Board and in accordance with § 2.2-4019, shall receive and review the application and any investigative report requested by the committee. The committee shall have the authority to grant or deny approval of the request. The committee may grant approval of the request unconditionally or may impose conditions on the approval as follows:
1. The committee may grant approval for a finite period of time, after which time the applicant must provide additional information as requested by the committee in order to continue the approval;
2. The committee may require that ongoing reports concerning performance and problems be submitted; or
3. The committee may impose such other conditions as it deems necessary to provide assurance of public health and safety and accountability for controlled substances.
D. If an applicant does not agree with the decision of the committee, the applicant may request a hearing before the Board or a panel of the Board, in accordance with § 2.2-4020.
E. Application under this section shall be on a form provided by the Board and shall be accompanied by a fee determined by the Board.
2000, c. 876.