Post Webinar Q&A
Is an alarm system still needed if our hospital is open 24/7?
Federal regulations do not address security requirements differently in this area. 21 CFR 1301.72(b)(3)(i) states“Has an electronic alarm system that meets 21 CFR 1301.72(b)(4)(v)”. This portion of regulations states:“Is equipped with an alarm system which upon unauthorized entry shall transmit a signal directly to a central station protection agency or a local or state police agency, each having a legal duty to respond, or to a 24-hour control station operated by the registrant, or to such other source of protection as the Administrator may approve.”
Based on the regulations, 24/7 operations are not excluded from the electronic alarm requirement. Instead of a system that is armed/disarmed during non-operational hours, they should implement an alarm system that incorporates 24/7 access controls to prevent unauthorized entry and that is connected to local law enforcement and monitored 24/7 by a control station.
When do you recommend having a hospital DEA license vs. a single practitioner license?
A “Hospital/Clinic” DEA registration is a subcategory of an Institutional Practitioner registration. If you are a DEA practitioner and are using that registration in a single-doctor type of practice setting, you are using your registration according to the types of activity individual practitioner registrations are intended for. If that is not the case and you are using an individual practitioner registration for a much larger and/or multifaceted operation then your DEA registration type needs to properly reflect the types of activities you are conducting.
If the owner of the practice buys the controlled substances under her DEA number, can she take them to the local Humane Society to use for surgeries if she returns them to the practice and all logs are maintained at the practice?
No, this is never allowed. Controlled substances ordered by a DEA registrant are to be used only at the DEA-registered location of record stated on the registration (with the exception of legitimate off-site patient care for which a veterinarian travels offsite to treat a patient with whom they have established a VCPR as allowed under the Veterinary Mobility Act of 2014). Transporting controlled substances to a local Humane Society falls under “black bagging”, which is specifically prohibited under registration provisionsin the Controlled Substance Act, requiring practitioners to obtain separate registrations for “each principal place of business or professional practice” where controlled substances are dispensed.Veterinarians fall under the definition of “practitioner” (DEA’s Practitioner’s Manual).
If a DEA registrant is listed as a practitioner, but the drugs ordered are for the entire hospital (5+ DVM practice), does the registrant need to be updated for business activity?
The business activity listed on a registration should always reflect the actual activities being conducted with controlled substances. If you are running a hospital of operation, registration activities should reflect that.
Does the DEA charge you to dispose of old controlled substances?
If by “old” you are referring to expired controlled substances in inventory that can no longer be used on patients, a DEA registrant may choose to contact the local DEA divisional office and request that the DEA come on-site and remove expired controlled substances from inventory to undergo destruction which there is not a charge for. Be aware though that by doing this you are voluntarily ask the DEA to come on-site and nothing prevents them from identifying other issues while they are on-site for which you can be cited. As a best practice, utilize a DEA-registered reverse distributor likeUnited RX Solutions who will conduct final destruction on your behalf and provide you with a Certificate of Destruction for your records.
If controlled substances go missing, what am I supposed to do?
With respect to suspected and/or confirmed controlled substance theft or significant loss, written notification must be made to the local DEA divisional office within one (1) business day of discoveryto include all known details at that time. If the loss is theft/confirmed a DEA Form-106 needs to be filed. If the loss is suspected, notification being made should indicate same and further state that the matter is being investigated internally, and if warranted, a DEA Form-106 will be submitted upon conclusion of the investigation.
DEA Final Rule: Reporting Theft or Significant Loss of Controlled Substances published on June 22, 2023, updated existing reporting requirements to clarify that all theft/significant loss DEA Form-106 submissions must be submitted electronically, and it provides DEA registrants with 45 days after discovery to conduct an internal investigation and compile/complete all necessary documentation related to the matter in question.
