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CFR Regulations - Researcher

Enforcement of DEA policies:

Apparently some TTUHSC  researchers are getting scheduled drugs from other researchers or veterinary staff.  This practice will be the subject of DEA interest, so it is suggested that you get  your own licensure at this time.  We are working with the DEA to facilitate this.  This applies to all  faculty and principle investigators using or administering scheduled drugs.  Laboratory staff can still handle drugs under the immediate direction of a licensed researcher / faculty member.  The licensed individual is ultimately responsible for their use.  Researchers will first get FEDERAL licensure following the procedure below and then apply for STATE licensure (the process is the different for physicians in practice).  The DEA application will ask for the state license number.  Simply leave that space blank.

Instructions from the DEA:

From 21 Code of Federal Regulations, Title 1301.11(a)..."Every person who manufactures, distributes, dispenses, imports, or exports any controlled substance or who proposes to engage in the manufacture, distribution, dispensing, importation or exportation of any controlled substance shall obtain a registration unless exempted by law..."  I've underlined dispensing because this would include the administering of controlled substances, which is what the researchers would be doing with the controlled substances.

Go to:  https://www.deadiversion.usdoj.gov -  From here, the applicant will click on a link on the right side of the screen for "New Applications".  Scroll down and select the "Form 225" button to apply as a researcher.  Below that the applicant will select "Researcher, II-V" (If you require schedule 1 drugs, please contact Mr. Hull below).  This is unusual.  Then, follow the on-screen instructions for name, address, drug schedules, etc.  You should know the drugs that you expect to use.  Others can be added later.  Dr. Mitchell is the certifying official.

HERE are excerpts from the Title 21 of the Code of Federal Regulations that pertain to researchers.  This information can also be found on the website listed above but these excerpts focus on registration, security and storage, and record-keeping requirements for researchers.

If anyone has any questions, feel free to call Christopher Hull at 817-639-2021 or mailto:Christopher.L.Hull@usdoj.gov.

PLEASE SEND EMAIL TO DR. JIM HUTSON, IF YOU ARE MAKING AN APPLICATION.  We can facilitate this.  Thank you.

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