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Showing posts from March, 2023

Recordkeeping Requirements for Controlled Substances

All DEA registrants are subject to a host of regulations which include maintaining a clear and complete record of the inventory of controlled substances. The form and period is also prescribed by the Act. The Drug Enforcement Administration (DEA) maintains a strict vigil over the manufacturing, prescribing, administering, dispensing and usage of the controlled substance drugs in tune with the stipulations of the Controlled Substances Act. The prescribed protocols for controlled substances require clear recordkeeping in the stipulated manner. This is applicable to veterinary controlled substances too with specific inventories and records in the form of a veterinary controlled drug log . Moreover, the inventory requirements also extend to the samples of controlled substances provided to healthcare practitioners by the pharmaceutical companies. That’s not all either. Records of controlled substances listed in Schedule I and II have to be maintained separately from all other records of co...

Mere Lock and Key Will Not Suffice for Controlled Substances

 All entities that are registered to handle controlled substances have to abide by a set of strict security requirements to ensure that they are not mishandled or misused in any manner whatsoever. The Controlled Substances Act requires that all DEA registered healthcare providers and other organizations – be it DEA veterinary or others – should institute effective controls and procedures to safeguard against theft and diversion of controlled substances. The standards for the mandated physical security controls and operating procedures are clearly laid out in the Code of Federal Regulations. There are slight variations in the requirements for practitioners and non-practitioners with certain distinctions in what is expected in case of manufacturing and compounding areas, narcotic treatment programs, freight forwarding facilities, etc. The security prerequisites are more stringent for Schedule I and II drugs. For instance, these must be stored in a safe or steel cabinet that is equiv...