What does FDA part J pertain to?

FDA Part J specifically pertains to the regulation of restricted drugs, which requires special handling, monitoring, and reporting due to concerns about their potential for abuse, misuse, or harm. These restrictions typically aim to ensure that both healthcare providers and patients use these drugs safely and effectively, due to the risks involved.

This part of the FDA regulations outlines the criteria and processes for the handling and distribution of these drugs, ensuring that they are prescribed and dispensed under strict conditions to mitigate associated risks. The emphasis is placed on protecting public health while still allowing access to necessary medications that may pose significant risks if not properly managed.

The other options, while related to medications, do not accurately reflect the focus of FDA Part J. Prescription drugs and over-the-counter medications fall under more general regulations, and nutritional supplements have a separate regulatory framework that does not include the specific limitations and monitoring associated with restricted drugs.