Which act clarified the regulation of compounding by pharmacies?

The FDA Modernization Act of 1997 is the correct answer because it specifically addressed and clarified the regulation of compounding by pharmacies. Prior to this act, there was a lack of clear statutory guidance regarding compounding practices, leading to confusion about the regulatory standards that applied. The act established definitions and guidelines that differentiated between traditional pharmacy compounding and manufacturing, thus helping to ensure patient safety while allowing pharmacists to prepare customized medications for individual patients when necessary.

The act made several key changes, including the establishment of provisions that allowed pharmacies to compound medications for dispensing based on individual patient prescriptions and provided further clarity on the requirements for record-keeping and labeling. Additionally, it created a pathway for pharmacies to engage in compounding without being classified as manufacturers, thus alleviating some of the regulatory burden while maintaining quality and safety standards in the practice of compounding.

The other acts listed do not specifically target the regulation of pharmacy compounding. The Kefauver-Harris Amendment primarily addressed the approval process for new drugs and required manufacturers to establish the efficacy of their products. The Food, Drug, and Cosmetic Act laid the groundwork for the regulation of food and pharmaceuticals but did not provide specific guidance on compounding. The Controlled Substances Act focuses on the regulation of controlled