Monday, December 1, 2014

Frequently Asked Compliance Questions About DEA Registration

Compliance with federal and state laws by health care providers (physicians, physician assistants, and advanced nurse practitioners) is critical. One of the frequently asked questions we receive is whether DEA registrants have to complete a separate registration when they practice at different locations. There is no simple answer to this question but the answer depends on whether the various locations are in the same state and whether there is any direct dispensing of controlled substances at the various locations.

What is the DEA law? It's always best to start with the statute or regulation as that is your road map.  Title 21 C.F.R. § 1301.12(a) states, “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.” 

Question: But I am not "dispensing," I am prescribing so do I need a DEA registration at the other locations?
Answer: Yes since under DEA law  the term "dispense" includes prescribing.Title 21 U.S.C. § 802(10) defines the word “dispense” as including the prescribing of a controlled substance.

Question: I have three offices in California where I am prescribing controlled substances, do I need a separate DEA registration for each office?
Answer: If you are only prescribing and are not maintaining supplies of controlled substances, administering, or directly dispensing controlled substances in these other locations in the same state, then you do not need to register the other offices.  21 C.F.R. § 1301.12(b)(3).

If your other practices are dispesing or administering controlled substances (even Schedule III or IV), that office needs a separate DEA registration. For example, if you have a weight loss clinic that dispenses phentermine in three different locations in the state then you need DEA registrations at each office.  Another example is that if your office injects human growth hormone (Schedule III) at different locations, then you need DEA registrations at each location. Even if you have the phentermine or HGH shipped to only one office and then have it transported to the other offices, you need DEA registration at each office.

Question: If I work locum tenens in other states do I need a separate DEA registration in that state?
Answer: Yes. You will need to obtain a separate DEA registration in each state where they plan to administer, dispense, or prescribe controlled substances.

Question: If am working solely in a hospital/clinic setting, can I may use the hospital’s DEA registration instead of registering independently with DEA if the hospital agrees?
Answer: Yes this is allowed under 21 C.F.R. § 1301.22(c).

Importance of Compliance. Make sure you are complying with all DEA registration requirements. Failure to follow them can result in discipline by the DEA and state licensing boards. One of the most common failures is for those practices that are dispensing controlled substances such as weight loss clinics who dispense phentermine. 

Compliance is not difficult but it does require setting up systems where all providers and staff must follow the rules. Failure to comply with these rules could result in criminal violations. Thus, following DEA rules helps protect everyone. We would rather focus on compliance rather than representing businesses and individuals when there have been violations but often our clients did not know the rules until there was an audit or visit by the DEA, government agency or licensing boards. Take the time and make sure you and your office is in compliance. One good thing is to review your compliance at the beginning of the year so that it is reviewed on a regular basis.

Posted by Tracy Green, Esq.
Green and Associates, Attorneys at Law


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