| 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. |
| Executive Branch Review | This action will go through the normal Executive Branch Review process. |
| RIS Project | Yes [004528] |
| Associated Mandates | Permits for outsourcing facilities |
| New Periodic Review | This action will not be used to conduct a new periodic review. |
| 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: ()- |