18 Va. Admin. Code § 110-20-321
Current through Register Vol. 41, No. 6, November 4, 2024
Section 18VAC110-20-321 - CompoundingA. The compounding of both sterile and nonsterile drug products by a pharmacy that does not share the same physical space with an outsourcing facility shall be performed in accordance with USP-NF compounding standards and § 54.1-3410.2 of the Code of Virginia.B. The compounding of sterile drug products by an outsourcing facility or by a pharmacy sharing the same physical space with an outsourcing facility shall be performed in accordance with current good manufacturing practices under § 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 USC § 351(a)(2)(B)) . NOTICE: The following forms used in administering the regulation were filed by the agency. The forms are not being published; however, online users of this issue of the Virginia Register of Regulations may click on the name of a form with a hyperlink to access it. The forms are also available from the agency contact or may be viewed at the Office of the Registrar of Regulations, General Assembly Building, 2nd Floor, Richmond, Virginia 23219.
18 Va. Admin. Code § 110-20-321
Derived from Virginia Register Volume 24, Issue 8, eff. January 23, 2008; Amended, Virginia Register Volume 33, Issue 20, eff. 6/28/2017.Statutory Authority: §§ 54.1-2400, 54.1-3434.05, and 54.1-3434.5 of the Code of Virginia.