Protecting controlled substances at your medical practice

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:

• Controlled substances shall be stored in a “securely locked, substantially constructed cabinet.” The intent is that controlled substances must be adequately safeguarded for the area. 

• Criminal background and DEA screening of all potential employees is critical.

• Practitioners are required  to notify the DEA of the theft or significant loss of any controlled substances within one business day of discovery of the loss or theft. When determining whether a loss is significant, the practitioner is required to consider certain factors, including the quantity and type of controlled substances lost, and whether they are likely candidates for diversion, considering local trends and other indicators. We advise practitioners to report any loss to the DEA, in case the diverted drugs are traced back to the practitioner’s office.

• Practitioners must maintain inventories and readily retrievable records of controlled substances dispensed in their practices, and the records must be maintained and available for inspection for at least two years.  Practitioners are not required to keep records of controlled substances they prescribe, although some do. Practitioners also are not required to keep records of controlled substances administered in their practices unless the dispensing or administering of controlled substances is a regular part of their practice and the patient is charged for the drug.

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 medec@advanstar.com.