Which part of the FDA includes controlled drug preparations?

The correct answer is Part G because this section of the Food and Drug Regulations specifically addresses controlled drugs and substances. In Canada, the regulation of controlled substances falls under the Controlled Drugs and Substances Act (CDSA), and Part G of the FDA outlines the requirements and provisions related to the manufacturing, distribution, and sale of controlled drugs.

This part ensures that there are stringent guidelines and regulatory measures in place to manage how these substances are handled, thereby promoting safety and compliance within the pharmaceutical industry. It includes stipulations on prescription requirements, the scheduling of different controlled drugs, and the responsibilities of pharmacies and pharmacy personnel in the management of these preparations. Understanding and adhering to Part G is crucial for pharmacy practitioners who handle controlled substances, ensuring they comply with legal and professional standards.