18VAC110-40-30: Approval of protocols outside the standard of care

A. If a practitioner and a pharmacist intend to manage or treat a condition or disease state for which there is not a protocol that is clinically accepted as the standard of care, the practitioner and pharmacist shall apply for approval. The committee shall, in accordance with § 2.2-4019 of the Code of Virginia, receive and review the proposed treatment protocol and recommend approval or disapproval to the boards.

B. Application and approval are not needed for treatment of conditions for which there is an accepted standard of care, but for which the practitioner wants to increase the monitoring and oversight of the condition over what the protocol recommends.

C. In order to apply for approval of a protocol outside the standard of care, the practitioner and the pharmacist shall submit:

1. An application and required fee of $750;

2. A copy of the proposed protocol; and

3. Supporting documentation that the protocol is safe and effective for the particular condition or disease state for which the practitioner and the pharmacist intend to manage or treat through an agreement.