DEA Storage and Recordkeeping Requirements

Our healthcare law firm works with many providers and healthcare practices who are facing an investigation from the Drug Enforcement Administration (DEA). This blog covers the DEA’s storage and recordkeeping regulations if you are storing or administering controlled substances as part of your practice. This blog does not cover the DEA regulations for dispensing controlled substances from your practice, which is prescribing and giving patients controlled substances for at-home use, similar to what a pharmacy does. If you are being investigated by the DEA for possibly violating the DEA’s storage and recordkeeping regulations, the DEA has approached your practice, or you would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

The DEA has implemented storage and recordkeeping regulations to protect against theft and diversion of controlled substances. The DEA requires Schedule II-V controlled substances to be stored in a “securely locked, substantially constructed cabinet.” As another requirement to protect against theft and diversion of controlled substances, the DEA prohibits practices and providers from employing anyone convicted of a drug-related felony or anyone who previously had a DEA registration denied, revoked, or surrendered for cause (e.g., surrendering a DEA registration as a result of or in lieu of an investigation related to the handling of controlled substances).

If a practice or provider experiences a possible theft or diversion, the DEA requires the practice or provider to notify the local DEA Field Division Office in writing of the theft or significant loss of any controlled substances within one business day of discovering the loss or theft and must file a DEA Form 106 within 45 days after discovering the theft or loss. The DEA lists six factors in determining whether a loss is “significant,” ranging from the quantity of controlled substances lost to the likelihood that the specific controlled substances in question are candidates for diversion.

Generally speaking, providers who prescribe or administer controlled substances in the lawful course of professional practice are not required to keep records of controlled substances. However, DEA regulations require practitioners who regularly dispense or administer controlled substances and charge patients, either separately or together with charges for other professional services, for controlled substances that are dispensed or administered to keep records of Schedule II-V controlled substances that are administered in the lawful course of professional practice. For each controlled substance your practice acquires and administers, the DEA requires practices and providers to include the following contents in the records: (1) the name of the controlled substance and its finished form/strength (e.g., 10-mg tablet or 10-mg concentration per fluid ounce or milliliter); (2) the date, quantity, and supplier (name, address, and DEA registration number) for each acquisition; (3) the date administered, the quantity/volume administered, and the patient to whom it was administered; (4) the written or typewritten name or initials of the person who administered it; and (5) the date, quantity, and manner of any disposal (including destruction), if applicable.

If your practice requires controlled substances to be destroyed, the practice is required to maintain a record of destruction on DEA Form 41. The regulations do not require the practice or provider to file a DEA Form 41 for a substance “dispensed by a practitioner for immediate administration at the practitioner’s registered location, when the substance is not fully exhausted,” such as when a substance remains in a vial, tube, or syringe after administration but cannot or may not be further used. Such a substance must be recorded according to the requirements in the above paragraph, though.

If you are being investigated by the DEA, the DEA has approached your practice, or would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

 

 

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