Notice is hereby given in accordance with § 2.2-4007.01 of the Code of Virginia that the Board of Pharmacy intends to consider amending 18VAC110-20, Regulations Governing the Practice of Pharmacy. In compliance with the second enactment clause of Chapter 300 of the 2015 Acts of the Assembly, the purpose of the proposed action is to adopt regulations to implement the requirement of law that facilities engaged in the compounding of sterile drugs and registered with the U.S. Secretary of Health and Human Services as outsourcing facilities must hold a permit to compound or ship compounded drugs into Virginia. The proposed amendments include (i) setting fees for approval of applications and renewal of permits and registration; (ii) specifying requirements for pharmacies that are or are not applicable to outsourcing facilities; (iii) establishing requirements for pharmacist supervision, recordkeeping, and renewal; and (iv) specifying that if a compounding pharmacy shares physical space with an outsourcing facility, the more stringent standards of good manufacturing practices are applicable.

The agency intends to hold a public hearing on the proposed action after publication in the Virginia Register.

Statutory Authority: §§ 54.1-2400 and 54.1-3307 of the Code of Virginia.

Public Comment Deadline: January 27, 2016.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4416, FAX (804) 527-4472, or email caroline.juran@dhp.virginia.gov.