What does NABP consider nonsterile compounding?
For purposes of NABP’s inspection and accreditation programs, we follow the definition of “compounding” provided by United States Pharmacopeia (USP).
According to USP <795>, nonsterile compounding is defined as, “Combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturer’s labeling, or otherwise altering a drug product or bulk drug substance to create a nonsterile preparation.” Handling of nonsterile hazardous drugs (HDs) must additionally comply with Hazardous Drugs—Handling in Healthcare Settings (USP <800>). This means that nonsterile compounding includes, but is not limited to, creating magic mouthwash from multiple ingredients, combining two commercially available creams together, and/or adding flavoring.
NABP does not consider mixing or reconstitution in accordance with directions contained in FDA-approved labeling by the manufacturer to be considered “compounding,” as described in the Food, Drug, and Cosmetic Act Section 503A (e).