Which conditions categorize a preparation as compounding?

A preparation is categorized as compounding primarily when it involves manipulations that expose its contents to the potential for contamination. This is a critical aspect of compounding, as it reflects the customized nature of the preparation, which often involves combining, mixing, or altering ingredients to create a medication tailored to the specific needs of a patient.

Compounding is intended to address unique patient needs, such as allergies to certain excipients or the need for a specific dosage form that is not commercially available. During the compounding process, there is an inherent risk that the product could become contaminated, hence this manipulation is a key defining characteristic of compounding.

In contrast, using only sterile products doesn't encompass the entirety of compounding, as compound preparations can be either sterile or non-sterile. The reliance on commercially available products is contrary to the very nature of compounding, which seeks to create preparations that aren’t readily available. Lastly, while compounding is subject to regulations, the notion that "no regulations apply" is misleading, as compounding must adhere to specific guidelines to ensure safety and efficacy. Thus, the emphasis on manipulations that expose contents to contamination accurately captures the essence of what defines a compounded preparation.