In This Section
Is the USP <797> definition of compounding the same as the FDA definition of compounding?
No. Compounding under USP is much broader and includes many more situations than are subject to the FDA definition of compounding.
The FDA states that "Compounding does not include mixing, reconstituting, or similar acts that are performed in accordance with the directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling" [21 USC 321 (k) and (m)].
The final revised version of USP fails to explicitly define the terms compounding and dispensing. However, USP does discuss the above-mentioned FDA statement about compounding, which clearly indicates that mixing or reconstituting performed in accordance with the instructions as stated in the package insert are not considered as compounding by the FDA. Nevertheless, the USP Expert Committee on Sterile Compounding—the committee that was responsible for the development of USP —believed that even the mixing and reconstituting processes that are carried out per the package insert's directions will be subject to the requirements of USP for the following reasons:
- The FDA-approved labeling (product package insert) rarely describes environmental quality (e.g., ISO class air designation, exposure durations to non-ISO classified air, personnel garbing and gloving, and other aseptic precautions by which sterile products are to be prepared for administration).
- Beyond-use exposure and storage dates or times (see "Determining Beyond-Use Dates" in USP)*for sterile products that have been either opened or prepared for administration are not specified in all package inserts for all sterile products.
- When such durations are specified, they may refer to chemical stability and not necessarily to microbiological purity or safety.
*A subscription is required to view USP , please see the USP website (www.usp.org) for more information.