Authorization of Users
1. Who must undergo a security screening, and how does the screening process work?
Section 1301.76 of the United States Drug Enforcement Administration (DEA) manual for registrants specifies that a DEA registrant “shall not employ, as an agent or employee who has access to controlled substances, any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a DEA registration revoked or has surrendered a DEA registration for cause”. In other words, the DEA requires that any individual with even limited access to controlled substances must complete a DEA screening certification and undergo a background check.
To aid investigators in complying with DEA requirements, the University’s Office of Human Resources has established a procedure to screen laboratory personnel who will have access to controlled substances. Such individuals must complete a DEA screening certification form, which must be signed by both the individual and the DEA registrant and submitted to Human Resources by the individual who will have access to controlled drugs. After the screening process is complete, the individual’s authorization to work with controlled substances is returned to the DEA registrant, for filing with other documents related to the DEA registration. Individuals who are authorized by the University to have access to controlled substances under the oversight of the DEA registrant are designated, by University policy, as Authorized Laboratory Personnel.
2. What is the difference between an “Authorized Agent” and “Authorized Laboratory Personnel”? Do both have to undergo the same screening process?
An Authorized Agent is an individual who has the complete trust of a DEA registrant, and who is authorized by the DEA registrant to oversee the ordering, dispensing and control of controlled substances in the absence of the DEA registrant. To minimize the risk of drug diversion, only 1-2 individuals in a laboratory can have the status of Authorized Agent. Only the DEA registrant and Authorized Agents can have key or combination access to the safe or locked cabinet where controlled substances are stored. Only Authorized Agents are permitted know the DEA registrant’s respective license number, and only Authorized Agents can order controlled substances on behalf of the DEA registrant upon his or her absence. Authorized Agents of the DEA registrant are required to undergo the DEA screening process (see question 1) and are thus also Authorized Laboratory Personnel.
It is understood that authorized individuals (i.e., Authorized Laboratory Personnel) in addition to the DEA registrant and Authorized Agents of the DEA registrant may participate in using controlled substances during experiments or treatments of research animals. Authorized Laboratory Personnel can perform these functions, but do not have key or combination access to the safe or cabinet where bulk quantities of controlled substances are stored. The DEA registrant or an Authorized Agent of the DEA registrant dispenses limited quantities of controlled substances to Authorized Laboratory Personnel for immediate use. All personnel who handle any quantity of controlled substances must undergo the DEA screening process.
3. If an Authorized Agent or Authorized Laboratory Personnel transfer to another lab or leave the University, do I need to notify someone?
No - There is no need to notify the DEA or University Human Resources if an Authorized Agent or Authorized Laboratory Personnel terminates his/her employment with a given laboratory or with the University.
4. Does a DEA registrant need to undergo the DEA screening process with University Human Resources?
No. A background check is conducted by the DEA when an individual applies for a DEA registration. As such, a redundant screening by the University is not required.
5. Authorized Agents and/or Authorized Laboratory Personnel in my laboratory are employed by UPMC, and not the University. Do they need to be cleared through the mechanism stipulated in the policy?
Yes. All individuals (including students and volunteers) who handle controlled substances used in University of Pittsburgh laboratories or under the direction of University of Pittsburgh faculty or staff are subject to the policy. All personnel who handle any quantity of controlled substances must undergo the DEA screening process.
Ordering Controlled Substances and Prescription Drugs
6. I am attempting to order antibiotics from a distributor, but they told me that they need verification documentation to prove that I am authorized to receive the drugs. How do I obtain this verification documentation?
Under the Pennsylvania Controlled Substance, Drug, Device, and Cosmetic Act, researchers are authorized to receive prescription drugs and are exempt from registration or licensure as long as the research is within the scope of their professional approved research protocol. However, a licensed distributor must perform due diligence and obtain verification documentation to ensure that parties they ship product to are authorized to receive it. The University has consulted with a large distributor of prescription drugs and devices, Henry Schein, and developed a “Certification of Exemption Memorandum,” which can be downloaded from: http://www.rcco.pitt.edu/ControlledDrugs/Forms/CertificationOfExemption.doc where is this document. Researchers should complete this form, and the investigator’s Department Chair or Dean must sign the form to verify that they have a need to order prescription drugs. The signed form must then be submitted to the distributor, with a copy sent to Purchasing Services (3328 Cathedral of Learning, Pittsburgh, PA 15260).
7. Do I need to submit all orders for controlled substances via mail?
Only orders for Schedule II controlled substances need to be delivered to University Purchasing Services, along with a copy of the investigator’s DEA registration, Researcher Verification Memorandum or PA Practitioner’s License, and signed DEA 222 form. Orders for Schedule III-IV drugs should be placed using the University’s PRISM system, provided that non-practitioners first submit the Certification of Exemption Memorandum to Purchasing Services (3328 Cathedral of Learning, Pittsburgh, PA 15260). No additional documentation needs to be provided to Purchasing Services unless the order exceeds $5,000. However, a copy of the investigator’s DEA registration and either the Certification of Exemption Memorandum or PA Practitioner’s License must be sent to the distributor.
Securing controlled substances
8. I have heard from the DEA that I need to double-lock controlled substances. What does that mean?
This means that two locks must protect the security of the controlled substances. A laboratory door that is locked when authorized personnel (i.e., the DEA registrant, Authorized Agent(s) of the DEA registrant, or Authorized Laboratory Personnel) are absent can serve as one of the “locks”. Within the laboratory, controlled substances must be secured within a locked cabinet or safe that cannot be moved or transported. Schedule I and II controlled substances must be secured within a specific type of safe or steel cabinet. The DEA regulations provide specifications regarding such enclosures. A narcotics cabinet (double lock, double door, which must be bolted to a wall) is recommended for drug storage. View example; item #3704.
The safe or cabinet must remain locked at all times when controlled substances are not being dispensed from or returned to storage.
9. Authorized Laboratory Personnel need access to controlled drugs over the weekend to treat an animal, when the DEA registrant or an Authorized Agent of the DEA registrant is not available. Is this permissible and, if so, how should the controlled substance be secured?
It is permissible to dispense small quantities of controlled substances for planned laboratory use in the near future. The substance removed should be placed in a secondary container; sterile controlled substances for administration to animals must be placed in a sterile secondary container such as a syringe. The secondary container must be labeled with the identity of the controlled substance, its lot or assigned control number and expiration date, and the identity of the DEA registrant. The information to be included on a secondary container label for materials intended for use in animals is specified in more detail in the IACUC Policy on Secondary Container Labeling.
In the case of weekend administration of a controlled substance by Authorized Laboratory Personnel, only the amount of the substance needed for the planned laboratory use can be dispensed from the bulk storage location (i.e., the controlled substances cabinet or safe). During weekend use, the dispensed controlled substance must be placed in a separate secure location in the lab, such as a locked drawer. Note that no individuals other than the DEA registrant or Authorized Agents of the DEA registrant can be provided keys to the bulk controlled substances cabinet or the combination to the controlled substances safe.
10. Can I share the drug locker of one my colleagues in the lab? We each have a current DEA registration.
Each DEA registrant should maintain his/her own secure lock-box or other secure location for storage of his or her own DEA-controlled substances.
11. I dropped a bottle containing DEA regulated substances and all of the material was spilled. What paperwork do I need to fill out, and do I have to use a reverse distributor to dispose of materials used to clean up the spill?
You need to document, in the respective drug accountability record, the volume of the DEA-controlled substance that was lost, and you must fill out and submit a Form 106 detailing the loss to the DEA. You do not need to use a reverse distributor to dispose of the materials used to clean up the spill.
12. Is there any difference in the procedures for discarding empty vials of controlled substances versus residual quantities of expired controlled substances?
Empty vials of controlled substances can be disposed of as medical waste, although the label should be removed or rendered unreadable. In addition, the disposal of the empty vial must be recorded in the respective controlled substances accountability record.
Expired containers of controlled substances (with any contents remaining) must be separated from non-expired containers of controlled substances, and must be clearly labeled as being expired. The expired containers of controlled substances must remain in the locked controlled substances cabinet or safe. The DEA registrant dispose of the remainder of the expired controlled substance through a DEA-registered Reverse Distributor. The University's Department of Environmental Health and Safety (EH&S) maintains an active contract with a DEA-licensed reverse distributor. Contact EH&S at 412-624-9505 for further information.
Final disposition of the expired quantity of the controlled substance must be documented on the respective controlled substance accountability record. Expired drugs can never be administered to research animals.
Obtaining a DEA registration
13. I have an office in Scaife Hall, but my laboratory is on Second Ave. What should I use as the address for my DEA registration?
DEA regulations require that registrants have a separate DEA registration for each location where controlled substances are received, stored or used. In general, if you are using DEA-controlled substances at a different location within the same building, but only storing controlled substances at one location in this building, your registration need only reflect the storage location. If you are receiving, storing or using DEA-controlled substances in more than one building, or if you are storing DEA-controlled substances in more than one location within the same building, you must have a separate DEA registration for each building and/or storage location. The Clapp-Langley-Crawford complex is considered to be within a single building, as is the Scaife-BST-BST3 complex. In all other cases, researchers should have separate DEA registrations for each of the separate buildings where DEA-controlled substances are being received, used or stored and/or separate DEA registrations for each location within the same building where DEA-controlled substances are being stored. Researchers, who are not licensed practitioners, should also have Pennsylvania Department of Health authorizations corresponding to each building or building location for which they have a DEA registration. To minimize the need for transferring controlled substances between multiple registrations held by a single researcher, you should order the DEA-controlled substances that you will need for each separate building/building location under the appropriate registration for such building/building location.
14. I am a licensed healthcare professional in the Commonwealth of Pennsylvania and have a practitioner’s registration with the DEA. Can I use this registration to cover my research (i.e., non-clinical) use of DEA controlled substances, or should I obtain a separate DEA registration for research use?
While a DEA registration held by a practitioner may permit research use of the specified DEA-controlled substance(s), the DEA registration is specific to a certain location where the DEA-controlled substances are being received, stored, or used. If you do not store controlled substances at your practice location, you may be able to maintain only one registration, located at the research site. Call the local DEA office (412) 777-1870 if you need more guidance.
15. I had an active DEA registration for a research protocol I was working on last year which has now ended. Can I just renew my registration in case I start another protocol which uses DEA regulated substances?
When researchers are no longer conducting studies under an approved research protocol that authorizes the use of DEA-controlled substances, they should promptly surrender their respective DEA registration to the DEA to avoid potential civil or administrative penalties. The DEA only grants registration to researchers who have a current need to access controlled substances for use in their research. Similarly, you should keep the schedules of DEA-controlled substances specified on your DEA registration current with the DEA, and promptly remove any schedules of DEA- controlled substances that are not authorized in your on-going research.
16. I just learned that a controlled substance that I commonly use is back-ordered at Henry Schein. My current supply may not meet the needs of ongoing studies before I can obtain a new order. What should I do?
Proper attention to the inventory of controlled substances in a laboratory should typically prevent shortages from occurring. If a controlled substance is back-ordered at Henry Schein, the DEA registrant or an Authorized Agent of the DEA registrant should contact University Purchasing Services (412) 624-6648 to obtain permission to order the controlled substance from an alternate supplier. If animals are in need of immediate treatments, the principal investigator must contact the Division of Laboratory Animal Resources (DLAR) to arrange for DLAR personnel to administer the controlled substance prescribed in the approved IACUC protocol governing the ongoing work. DLAR will charge the investigator for time involved in providing controlled substance treatments to animals.
17. I suspect that controlled substances have been stolen from the lab, but since I am not the DEA registrant or an Authorized Agent of the DEA registrant, I can’t be sure. What should I do?
The DEA registrant holds ultimate responsibility for the oversight of controlled substances maintained and/or used under his/her direction. Hence, any suspicion of possible diversion of a controlled substance should be initially brought to the attention of the DEA registrant. The DEA registrant should promptly report suspicion of drug loss or theft to the attention of the University of Pittsburgh Police Department (412-624-4040), and to the DEA Field Office (412) 777-1870. Notification to the DEA should include prompt completion by the DEA registrant of a DEA Form 106.