What does NABP consider sterile 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 <797>, sterile compounding is defined as, “Combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug product or bulk drug substance to create a sterile preparation.” Handling of sterile hazardous drugs (HDs) must additionally comply with Hazardous Drugs—Handling in Healthcare Settings (USP <800>).
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) and under Section 1.4 of Preparation Per Approved Labeling within USP <797>.