What is the federal regulation governing records of controlled substances?

The federal regulation governing records of controlled substances is outlined by the DEA regulations. The Drug Enforcement Administration (DEA), part of the U.S. Department of Justice, is responsible for enforcing the Controlled Substances Act (CSA). This includes establishing the legal framework for the handling, distribution, and documentation of controlled substances to prevent misuse and ensure safe practices.

Under DEA regulations, pharmacies, healthcare practitioners, and other entities that handle controlled substances must maintain accurate records of all transactions involving these substances. This includes records of prescriptions issued, inventory logs, and documentation of any transfers or disposals of controlled substances. Compliance with these regulations is crucial for tracking controlled substances and demonstrating accountability to prevent diversion.

Other choices, such as FDA regulations, focus primarily on drug approval and safety rather than the specific handling and record-keeping of controlled drugs. ACPE guidelines pertain to pharmacy education and accreditation but do not govern the records of controlled substances. NABP recommendations provide guidance for pharmacy practice but do not hold legal authority like the DEA regulations do. Thus, the correct choice reflects the legal requirements mandated by federal law for maintaining records of controlled substances.