Which Act regulates prescription drug sample sales and their recordkeeping requirements?

The Prescription Drug Marketing Act (PDMA) specifically regulates the distribution of prescription drug samples and establishes stringent recordkeeping requirements for their distribution. This legislation aims to ensure that drug samples are provided to healthcare professionals in a safe manner, preventing fraudulent or unsafe practices related to drug samples.

Under the PDMA, manufacturers must maintain accurate records of the distribution and handling of these samples, which includes tracking the samples from the manufacturer through to the healthcare professionals who receive them. This requirement is essential for minimizing the risk of misuse and for ensuring that patients ultimately receive quality medications.

Other acts mentioned in the options do have important roles in the regulation of drugs but do not specifically focus on the issues of drug sample sales and their associated recordkeeping. For instance, the Controlled Substances Act primarily governs the regulation of controlled substances and does not cover the specifics of drug sampling. The Food, Drug, and Cosmetic Act lays out the overall framework for drug approval and safety but does not pertain to prescription drug samples specifically. The Durham-Humphrey Amendment addresses the distinction between prescription and over-the-counter medications but does not regulate samples directly.