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Controlled Substances Questions and Answers

Who must register with the DEA?

A Principal Investigator (PI) or person who wishes to conduct research involving a controlled substance must first be registered with the Drug Enforcement Agency (DEA).

 

Who is considered a DEA registrant?

A DEA registrant refers to the Principal Investigator (PI) who will conduct research involving a controlled substance who possesses a “Research” category registration issued through the DEA.

 

I have an office in the Medical Education Research Building (MERB) on the Health Sciences Campus, but my laboratory is located on another floor, in another building or on another campus.  What should I use as the address for my DEA registration?

  • The DEA regulations require that registered researchers have a separate registration for each location where controlled substances are received, stored or used.
  • If you are planning to receive, store or use DEA controlled substances in more than one building or you are storing DEA controlled substances in more than one location within the same building, then you must either request amendment to your DEA registration or have a separate registration for each building and location.
  • The local DEA field office must be consulted first and grant the registrant approval if you wish to have multiple locations on a single DEA registration.  The DEA will review and may conduct a site visit and review the circumstances surrounding your request.   

 

Who is an “Authorized User”?

Authorized Users are research staff, including graduate students and postdoctoral scholars that work with controlled substances under the direct supervision of a researcher (registrant) who has an active DEA registration.

 

Do Authorized Users undergo a background check or screening?

Yes, authorized users are required to go through a DEA background check or screening (21 CFR 1301.90). The DEA registrant is ultimately responsible for the management of the controlled substances acquired under their DEA registration.  Therefore, each registrant is responsible for ensuring that that all authorized users working under their registration undergo background check/screenings, specific roles are authorized/documented and all the required training is completed prior to granting authorization.    The registrant must ensure that the University Employee Questionnaire is completed for each authorized user working under their registration.  Temple University Human resources can assist in performing the background check.

 

Can I share a drug safe/vault/narcotic safe with one of my colleagues in the lab?  We each have a current DEA registration.

Each DEA registrant must maintain his/her own secure safe/lock box or other secure location for storage of his or her own DEA-controlled substances.

How do I dispose of my controlled substance?

You may dispose of out of date, damaged, or otherwise unusable or unwanted controlled substances, including samples, by transferring them to a third party company who is authorized by the DEA to receive such materials.  These commercial operators are referred to as a reverse distributor.  The registrant should contact the Philadelphia Field Office for a list of authorized Reverse Distributors.

Schedule I and Schedule II controlled substances must be transferred via the DEA form 222, while Schedule III-V substances may be transferred via an invoice.  The registrant must maintain copies of the records documenting the transfer and disposal for a period of 2 years after disposal of a controlled substance.  There is a charge for the use of a reverse distributor.  The cost of the waste disposal depends on the type and quantity of the substance.  You may also try contacting the manufacturer to request authorization to return the controlled substance directly to them.

 

Can I transfer a controlled substance between University Registrants?

Yes, the transfer of a controlled substance between University Registrants is allowed as long as the following conditions are met:

  • All federal regulations, Temple Policies and security requirements must be reviewed and followed prior to conducting the transfer of a controlled substance.
  • Registrant may only transfer controlled substances to other registrants at the University. Each registrant must be approved to possess the scheduled drug or chemical that is transferred.
  • The following information must be included and maintained in the records of both the supplier and the recipient of the transferred controlled substance.  The following information must be included in any document used to transfer a controlled substance.
    • Name, address, and DEA registration of the recipient.
    • Name, address, and DEA registration number of the supplier
    • Name, concentration, and quantity of controlled substance transferred
    • Transfer date
  • A DEA Form 22 must be used for transfer of Schedule I and II substances. The recipient must submit attached copies one and two to the supplier. The supplier must retain one and submit copy two to the DEA.
  • Any documentation must be signed and date by both the supplier and recipient upon delivery. The form/document should be filed with inventory records and kept for at least two years.
  • Secure and log the newly received controlled substance into the current inventory upon delivery. The recipient must complete copy three of DEA Form 222 if the substances received are in schedule I or II.  
  • Registrant can only transfer up to 5 percent of their annual total controlled substances dosage units to other registrants without having to acquire a separate distributer registration.

 

Can practitioners perform research with their own DEA registration?

Practitioners with their own DEA registration may conduct research (human or animal) with those substances for which the registration was granted as long as the records for research are kept separate from all other records.

 

Can practitioners perform research with their own DEA registration at any location?

Practitioners can only order, receive, dispense or store controlled substances at the same business address as stated in the DEA registration.  For example, if a practitioner has a DEA number for location A and wants to conduct research that requires ordering, dispensing or administrating controlled substance at location A , then there is no need to get a new DEA registration as long as research records are kept separately.

However, if the practitioner practices medicine at location A that includes ordering controlled substances for dispensing or administering to conduct research at location B, then a researcher registration for location B is required.

 

Can practitioners take their controlled substances from the location stated in the DEA registration to another location to perform research?

Practitioners are not authorized to transfer controlled substances to another location. Therefore, if the location of research is not the same as the location stated in the DEA registration, then  practitioners needs to get a separate research DEA registration for the research activity.

 

Can individuals with a research DEA registration perform chemical analysis at the same location?

Research DEA registrants can use their DEA registration to perform chemical analysis at the same location stated in their DEA registration.

 

Should research DEA registrants notify DEA when controlled substances are going to be used on different research projects?

When the researcher applies for DEA registration, the local DEA office will conduct a pre-registration interview to include the research protocol as it relates to the controlled substances. No additional information is required if the drugs are also used on additional or subsequent projects. This applies to Schedule II – V controlled substances. Use of Schedule I controlled substances in research require a separate DEA registration and application process.

 

Should research DEA registrants notify the DEA when there is a change in location of use, storage or administration of controlled substances? If so, does this require a new DEA registration or can it be done as an amendment to the existing registration?

Any time registrants move their principal place of business, they must notify the DEA.

 

Research DEA registrant. Can controlled substances be dispensed or administered at location B if location B is at the same building as location A.?

The registrant cannot transfer, move or relocate controlled substances from the registered location to any other location. The registered location is the only place the controlled substances may be stored, dispensed and/or administered.

 

Research DEA registrant has a principal place of business on the DEA registration as location A. Can controlled substances be dispensed or administered at location B if location B is within walking distance of location A.?

The registrant cannot transfer, move or relocate controlled substances from the registered location to any other location. The registered location is the only place the controlled substances may be stored, dispensed and/or administered.

 

Research DEA registrant has a principal place of business on the DEA registration as location A. Can controlled substances be dispensed or administered at location B if location B is driving distance from location A?

The registrant cannot transfer, move or relocate controlled substances from the registered location to any other location. The registered location is the only place the controlled substances may be stored, dispensed and/or administered.