                                 CODE OF VIRGINIA

APPROVAL OF INNOVATIVE PROGRAMS (§ 54.1-3307.2)

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 (&#xA7; 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 &#xA7; 54.1-3401.

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&#8217;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 &#xA7; 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.

HISTORY: 2000, c. 876.