How frequently should those who manufacture, dispense, and distribute controlled substances be inspected?

The correct answer is that those who manufacture, dispense, and distribute controlled substances should be inspected at least every three years. This requirement aligns with federal regulations, specifically the Drug Enforcement Administration (DEA) guidelines, which state that registrants must be inspected periodically to ensure compliance with the Controlled Substances Act. The three-year interval is designed to provide a balance between regulatory oversight and the operational realities faced by entities that handle controlled substances.

This frequency allows for regular checks on the practices of pharmacies, manufacturers, and distributors, verifying that they maintain proper records, storage, and security measures for controlled substances. It also emphasizes the importance of ongoing compliance to safeguard against issues such as diversion or misuse of these substances.

While some options suggest annual or more frequent inspections, this may not be practical or necessary for all entities, especially considering the varying sizes and scopes of operations within the pharmaceutical industry. The three-year inspection cycle gives ample opportunity for oversight while not placing excessive strain on the resources of both regulators and the businesses being inspected.