Recently, a medical staff manager from a client hospital let me know a corporate auditor informed her that the medical staff office must collect from each medical staff member a copy of a DEA registered in the state in which this client is located (Tennessee) and that a DEA registered in another state (Georgia) is unacceptable.  The client hospital is located on a city that borders two states, and many medical staff members have practice locations in Georgia and DEAs registered in that state.  Of course, those medical staff members had licenses to practice in Tennessee, which would otherwise authorize these physicians to prescribe.  According to the auditor, new DEA rules required the physicians to have a DEA registered to a practice location in Tennessee in order to write prescriptions for controlled substances in Tennessee.

The regulation in question is Section 1301.12 Separate registrations for separate locations:

(a)    A separate registration is required for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, imported, exported, or dispensed by a person.

This situation gave me pause.  I knew that practitioners must have a DEA registration for the practice location in which they *dispense* controlled substances.  However, I wasn’t certain that prescribing in the hospital setting was the same as “dispensing.” According to the DEA enabling law, the term ''dispense'' means to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling or compounding necessary to prepare the substance for such delivery. The term ''dispenser'' means a practitioner who so delivers a controlled substance to an ultimate user or research subject.  (21 USC Sec. 802)  A prescription, on the other hand, is an order for medication which is dispensed to or for an ultimate user but does not include an order for medication which is dispensed for immediate administration to the ultimate user (e.g., an order to dispense a drug to an inpatient for immediate administration in a hospital is not a prescription). 

As it turns out, the DEA issued a rule in 2007 making it clear that when an individual practitioner practices in more than one state, he or she must obtain a separate DEA registration for each state.  The DEA responded to concerns raised by practitioners about the changes this rule change would require:

As mandated in the Controlled Substances Act, DEA issues registrations based on the State license to practice medicine and dispense controlled substances. Section 823(f) of Title 21, U.S. Code, states that DEA shall register a practitioner to dispense controlled substances if the applicant is authorized to dispense controlled substances under the laws of the State in which the applicant practices. Just as a license to practice medicine in one State does not authorize a practitioner to practice in any other State, a DEA registration based on a particular State license cannot authorize dispensing controlled substances in another State. As DEA pointed out in the NPRM, different States may provide a practitioner with different prescribing authority; State medical licenses may be suspended or revoked in one State, but not another. A single DEA registration would, in effect, divorce the DEA registration from State authorizations. . . . DEA recognizes that the requirement to have separate DEA registrations for each State imposes a burden on practitioners who practice in multiple States. However, DEA notes that it received only nine comments from practitioners or their representatives; currently, DEA has almost 1.1 million practitioner registrants. This may indicate that most practitioners operating in multiple States already hold appropriate DEA registrations.

Since federal courts have interpreted the mere writing of a prescription as “dispensing,” the DEA also jumped that logical hurdle:

A practitioner must have a DEA registration for any State in which he or she is dispensing (including prescribing) controlled substances. A practitioner must have a separate registration for each location at which he or she stores, administers, or directly dispenses controlled substances.

And there you have it: physicians and other LIPs who can prescribe controlled substances under state and federal law must have a DEA registration in the state in which they see patients even if they don’t have an office (practice) in that state.

The DEA does make special considerations for locum tenens practitioners and telemedicine. Locum tenens practitioners have options regarding their DEA registration when planning to legally handle controlled substances in multiple states:

• A practitioner can apply for a separate DEA registration in each state where they plan to administer, dispense, or prescribe controlled substances;

• As an alternative, if the practitioner will be working solely in a hospital/clinic setting, they may use the hospital’s DEA registration instead of registering independently with DEA if the hospital agrees and the situation warrants, as outlined in 21 C.F.R. §1301.22(c);

• Alternately, under 21 C.F.R. §1301.51, the practitioner may transfer their existing DEA registration from one state to another as needed by contacting ODR, or requesting the change online at www.DEADIVERSION.USDOJ.GOV.

As for telemedicine and electronic prescribing, the DEA has been pushed recently to produce final rule that define acceptable practice.  Recently, the DEA tackled the issue Internet pharmacies and prescribing this past year, but has carved out telemedicine providers from these limits.  Also, many telemedicine physicians practice in specialties that do not routinely prescribe (i.e., radiologists) or have avoided the prescribing issue entirely until there is clarity on this new medical practice area.

For more information about DEA's controlled substance regulation, go to the DEA website questions and answers page.

March 23, 2010