Administrative Code

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Virginia Administrative Code
Title 18. Professional And Occupational Licensing
Agency 85. Board of Medicine
Chapter 20. Regulations Governing the Practice of Medicine, Osteopathic Medicine, Podiatry, and Chiropractic

18VAC85-20-410. Requirements for low-risk, medium-risk, or high-risk sterile mixing, diluting, or reconstituting.

A. Any mixing, diluting, or reconstituting of sterile products that does not meet the criteria for immediate-use as set forth in 18VAC85-20-400 A shall be defined as low-risk, medium-risk, or high-risk compounding under the definitions of Chapter 797 of the U.S. Pharmacopeia (USP).

B. Doctors of medicine or osteopathic medicine who engage in low-risk, medium-risk, or high-risk mixing, diluting, or reconstituting of sterile products shall comply with all applicable requirements of the USP Chapter 797. Subsequent changes to the USP Chapter 797 shall apply within one year of the official announcement by USP.

C. A current copy, in any published format, of USP Chapter 797 shall be maintained at the location where low-risk, medium-risk, or high-risk mixing, diluting, or reconstituting of sterile products is performed.

Statutory Authority

§ 54.1-2400 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 23, Issue 25, eff. September 20, 2007; amended Virginia Register Volume 35, Issue 24, eff. September 16, 2019.

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