Agencies | Governor
Virginia Regulatory Town Hall
Agency
Department of Health Professions
Board
Board of Pharmacy
chapter
Regulations Governing the Practice of Pharmacy [18 VAC 110 ‑ 20]
Action:
Outsourcing facilities
 
General Information
Action Summary In compliance with the second enactment clause of Chapter 300 of the 2015 Acts of the Assembly, the Board of Pharmacy is promulgating 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. Regulations set fees for approval of applications and renewal of permits and registration. Requirements for pharmacies that are or are not applicable to outsourcing facilities are specified, and requirements for pharmacist supervision, recordkeeping, and renewal are also established. Finally, regulations specify that if a compounding pharmacy shares physical space with an outsourcing facility, the more stringent standards of Good Manufacturing Practices are applicable.
Chapters Affected Only affects this chapter.
Exempt from APA No, this action is subject to the Administrative Process Act and the standard executive branch review process.
RIS Project Yes  [004528]
Associated Mandates Permits for outsourcing facilities
 
Stages
Stages associated with this regulatory action.
Stage ID Stage Type Status
7353 Emergency/NOIRA Stage complete. Emergency regulation expired on 6/6/2017.
7508 Proposed Stage complete. Comment period ended 12/30/2016.
7887 Final Stage complete. This regulation became effective on 6/28/2017.
 
Contact Information
Name / Title: Caroline Juran, RPh  / Executive Director
Address: 9960 Mayland Drive
Suite 300
Richmond, VA 23233-1463
Email Address: caroline.juran@dhp.virginia.gov
Phone: (804)367-4456    FAX: (804)527-4472    TDD: ()-

This person is the primary contact for this chapter.