2006 Code of Virginia § 54.1-3307.2 - Approval of innovative programs

54.1-3307.2. Approval of innovative programs.

A. Any person who proposes to use a process or procedure related to thedispensing of drugs or devices or to the practice of pharmacy notspecifically authorized by Chapter 33 ( 54.1-3300 et seq.) of this title orby a regulation of the Board of Pharmacy may apply to the Board for approvalto use such process or procedure. The application under this section may onlyinclude new processes or procedures, within the current scope of the practiceof pharmacy, that relate to the form or format of prescriptions, the mannerof transmitting prescriptions or prescription information, the manner ofrequired recordkeeping, the use of unlicensed ancillary personnel in thedispensing process, and the use of new technologies in the dispensingprocess. The authority granted the Board under this section shall notauthorize expansion of the current scope of practice for pharmacists andshall not interfere with the requirement that pharmacists only dispense drugsin accordance with instructions from a prescriber, as defined in 54.1-3401.

B. The application to the Board shall address safety to the public regardingthe new process or procedure, any potential benefit to the public, promotionof scientific or technical advances in the practice of pharmacy, compliancewith prescriber's instructions for any drug dispensed, any impact the newprocess may have on the potential for diversion of drugs, maintenance in theintegrity of and public confidence in the profession of pharmacy and of thedrugs dispensed, impact on cost to the public and within the health careindustry, means of monitoring the new process or procedure for any negativeoutcomes or other problems, and the reporting of such outcomes to the Board.

C. An informal conference committee, composed of not less than two members ofthe Board and in accordance with 2.2-4019, shall receive and review theapplication and any investigative report requested by the committee. Thecommittee shall have the authority to grant or deny approval of the request.The committee may grant approval of the request unconditionally or may imposeconditions on the approval as follows:

1. The committee may grant approval for a finite period of time, after whichtime the applicant must provide additional information as requested by thecommittee in order to continue the approval;

2. The committee may require that ongoing reports concerning performance andproblems be submitted; or

3. The committee may impose such other conditions as it deems necessary toprovide assurance of public health and safety and accountability forcontrolled substances.

D. If an applicant does not agree with the decision of the committee, theapplicant may request a hearing before the Board or a panel of the Board, inaccordance with 2.2-4020.

E. Application under this section shall be on a form provided by the Boardand shall be accompanied by a fee determined by the Board.

(2000, c. 876.)

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