Separate Registrations Requirements and Violations
While working at the Administration, I often saw examples of statutes and regulations held sacrosanct by DEA that were more often than not unknown or ignored by registrants in the field. Lack of knowledge of a requirement under the CSA or CFR is no defense in a DEA enforcement action. One of the more common violations by practitioners involves the requirement to have a separate DEA registration for every separate location where a practitioner may dispense or prescribe controlled substances.
Under 21 CFR § 1301.12, a separate registration is required for each principal place of business or professional practice at one general physical location where controlled substances are distributed or dispensed. Additionally, under the CSA, “dispensing” includes delivering a controlled substance to an ultimate user by means of issuing a prescription. 21 USC § 802(10). What this means together is simple: a practitioner is required to obtain and maintain a separate registration at every practice he or she intends to issue prescriptions to patients.
In theory, the DEA interpretation of this regulation draws a clear line when it comes to multiple registrations. Any doctor working at two separate offices, whether under the same practice name or not, is required to obtain a separate registration for each. And in a clean, orderly universe, the DEA interpretation would seem uncomplicated.
However, DEA has historically faced more complicating factors in relation to the requirement for separate registrations. Many Emergency Room physicians, practicing at multiple hospitals, face questions of whether they need a registration for each hospital, or if they are allowed to prescribe under the hospital registration at each. What about emergency medical response vehicle drivers, who may have on hand life-saving medications, but whose location changes frequently? Or farm veterinarians who travel to sick animals to dispense and administer controlled substances?
DEA has provided some guidance over the years, but has historically enforced regulations such as this as “Forget what we said or didn’t say then, this is what we say now!” While the agency may understand how it interprets its own regulations, often times the registrants are left perplexed until it’s too late.
Mr. Novak is a former attorney for the United States Department of Justice Drug Enforcement Administration. Jonathan is now working nationwide representing public entities, including counties, cities, and Native American tribes, in litigation against manufacturers and distributors of opioid controlled substances, as well as providing education and legal guidance on state and federal controlled substance regulations. If you have any questions or concerns regarding regulatory compliance, state or federal enforcement action on your controlled substance or pharmacy registration, or if you represent a public entity interested in learning more about potential litigation against opioid manufacturers and distributors, please contract Jonathan directly ([email protected] )
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