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Many practitioners store, administer, or dispense controlled substances in the office, but they may not be aware of legal requirements concerning the safeguarding and record-keeping of these drugs.
Barbara D. Knothe, JDMany practitioners store, administer, or dispense controlled substances in the office, but they may not be aware of legal requirements concerning the safeguarding and record-keeping of these drugs.
The U.S. Drug Enforcement Administration (DEA) has stepped up enforcement efforts against distributors, prescribers, and pharmacies, bringing administrative, civil, and criminal actions to combat diversion of controlled substances. These actions can result in denial or revocation of a DEA registration, civil penalties, and criminal prosecution.
The DEA tracks the ordering and dispensing of controlled substances through its database, through onsite inspections of pharmacies and physicians’ offices, and through “suspicious order reports” from distributors. The administration is authorized to conduct unannounced onsite inspections of registered locations, including dispensing physicians’ offices.
Also, the DEA has the authority to inspect and evaluate the overall security systems of practitioners to determine if they meet the intent of the law, which is to prevent theft or diversion.
Federal regulations set forth specific physical security controls for practitioners:
Many state laws are more stringent than federal law and must also be complied with. For example, New York state law and regulations require state registration, safeguarding, and record keeping for controlled substances in the office setting. New York practitioners must maintain meticulous records of all controlled substances received and administered or dispensed.
Federal and state laws carry significant administrative, civil, and criminal penalties for violations of controlled substance laws. Strict adherence to all physical safeguarding and recordkeeping rules is vital in the practice setting.
Barbara D. Knothe, JD, is a partner in Garfunkel Wild, P.C.’s Health Care Practice Group, in Great Neck, New York. Send your legal questions to firstname.lastname@example.org.