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Remember to Audit Your Controlled Substance Program

In MA, there are two regulatory agencies that enforce controlled substances, the Drug Enforcement Administration (DEA) and the Massachusetts Department of Public Health, Drug Control Program (DCP).  Any facility licensed to store and use controlled substances for research purposes must comply with the applicable regulations and conditions of their license and registration.

The DEA has established five schedules of controlled substances, schedules I-V, and the DCP regulates one additional category, establishing schedules I-VI.  Every license and registration issued will specifically authorize the approved schedules of controlled substances.

There are specific recordkeeping requirements that stipulate the need for maintaining a current record of all controlled substances purchased, received, distributed, and disposed of.  A perpetual inventory should be maintained and audits of the inventories in place must be conducted.  A site specific ordering process should be implemented and strictly complied with.  Any orders or transfers of schedules I and II substances must be processed using DEA Form-222.  Upon receipt, controlled substances must be stored in the appropriate secured and authorized storage locations.  The disposal of controlled substances is also strictly regulated, with continued requirements for tracking.  Any suspected theft or loss of controlled substances must be immediately reported to both the DEA and DCP.

Remember to audit your program frequently to ensure that your requirements are being adhered to on an ongoing basis.

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