Which of the following distinguishes compounding from manufacturing?

Compounding is distinguished from manufacturing primarily by the characteristic that compounded medications are not commercially available. This means that they are typically made to meet the specific needs of an individual patient when a commercially available medication does not suffice or is not suitable for that patient. For example, a compounded medication can be formulated in a specific dosage form, strength, or with particular excipients that a patient may require, tailoring it directly to their health needs.

The emphasis on compounding being for individual patients helps clarify the role of pharmacists in personalizing treatments, setting it apart from manufacturing, which focuses on producing large quantities of uniform medication products for widespread distribution and commercial sale. Moreover, compounded medications are often prepared in response to a specific prescription, reinforcing the patient-oriented nature of compounding, whereas manufactured products are produced for the mass market and are FDA-approved as finished products.

This distinction is crucial for understanding the regulatory frameworks and legal responsibilities that govern these two practices within the pharmacy profession.