Which regulation governs the handling of controlled substances in pharmacy practice?

The handling of controlled substances in pharmacy practice is primarily governed by DEA regulations. The Drug Enforcement Administration (DEA) enforces the Controlled Substances Act (CSA), which establishes a framework for the legal manufacturing, distribution, prescribing, and dispensing of controlled substances. This regulation is crucial because it sets the standards for the security and accountability necessary to prevent the misuse and diversion of these medications.

While FDA guidelines and state pharmacy laws also play significant roles in pharmacy practice, their scope does not specifically focus on the regulation of controlled substances in the same way the DEA regulations do. The FDA oversees the approval and safety of pharmaceuticals, while state pharmacy laws can vary widely and may include rules regarding other aspects of pharmacy practice, but they must align with and cannot contradict the federal regulations imposed by the DEA.

Therefore, the emphasis on DEA regulations underscores their importance in establishing uniform standards for handling controlled substances, making this the correct response.