What is defined as a preparation intended to be sterile created by altering a drug product?

A preparation intended to be sterile that is created by altering a drug product is referred to as a compounded sterile preparation. This definition is rooted in the practice of pharmacy, where compounding involves the customization of medications to meet specific patient needs. Compounded sterile preparations are crucial for delivering medications that require strict sterility, such as those used in intravenous therapies or other applications where infection risk must be minimized.

Compounded sterile preparations are distinct from standard dosage forms, which are commercially available, pre-manufactured products that do not require alteration before use. The term pharmaceutical formulation generally encompasses a wider range of drug preparations, including both compounded and manufacturer products, without specifically implying the necessity for sterility. Biologics refer to a different category of products derived from living organisms and are not specifically related to sterile compounding. Thus, the clarity of the term "compounded sterile preparation" accurately reflects the specific context of creating a sterile drug preparation tailored for patient use.