DEA Controlled Substances and Pharmaceutical Products

OBJECTIVE

The Objective of this policy will be to provide guidelines for the use, storage and disposal of Drug Enforcement Agency (DEA) Controlled Substances and all other pharmaceutical products being used in research laboratories.

By authority of the University President, the Vice President for Business Affairs is responsible for the safety of all University facilities. Under this authority, policies are developed to provide a safe teaching, research, service, housing and recreational environment.

Reference
Florida Governor’s Executive Order Number 00-292
Title 21 United States Code (USC) Controlled Substances Act
Florida Statutes, Title XXXII, Chapter 445 Business and Professional Regulation: General Provisions

The Policy on use of the Pharmaceutical and Drug Enforcement Agency Controlled Substances in Research and attached EHS guidelines will establish the minimum requirements necessary for UF researchers to use, store and dispose of all DEA controlled substances and pharmaceutical products, are used in conducting research at the University. The EHS guidelines outline the process for obtaining the required Florida Department of Business and Professional Regulations exemption for the use of pharmaceutical products and the DEA registration for use of controlled substances. The guidelines also provide the procedures and instructions for record keeping, storage and disposal of these products.

Principal Investigator (PI)
The UF PI overseeing the use of pharmaceutical and controlled substance is ultimately responsible for all aspects of use, storage, disposal and associated recordkeeping of these products, even if the handling and use had been delegated to lab staff. PIs must provide the authorization to research staff for the use of these products and train then appropriately. . PIs aree responsible for attaining and renewing both the State of Florida exemption for use of pharmaceutical products in research and the DEA registration (if required). Paperwork must be made readily available in the event of an inspection or audit. Secure storage must be provided for the use of controlled substances as defined in the guidelines below.

Research Staff
Upon the approval by the PI, lab staff may be “authorized users” responsible for the use, handling, storage, and disposal of these products as directed by the PI.

Environmental Health and Safety
The EHS Laboratory Safety staff support compliance with the use of DEA controlled substance and pharmaceutical products through training sessions, guidelines, consultations and inspections. Lab Safety staff will escort the DEA inspectors during their audits and act as a liaison for the institution.

Policy#: UFEHS-LS001- 10/11/13
History: Originated 10/11/13, Revised: 9/4/2020

Overview

This program will be focused and aimed at the use of any pharmaceutical grade product in UF research laboratories, including drugs classified as “controlled substances” by the US Drug Enforcement Administration (DEA). This is written for Principal Investigators (PI), as they are ultimately responsible for the use and storage of the products and the authorization of their staff that will have access to and use the products.

The University of Florida requires each PI to have an individual DEA registration for research (separate from a clinical DEA registration). DEA Controlled Substances cannot be shared between PIs, unless both PIs are co-researchers on the same grant and the second PI is listed as an authorized user under the PI with the registration.

The products that are included in this program will include, but are not exclusive to: DEA controlled substances, pharmaceutical grade antibiotics used for animals or tissue culture, medical grade gases (including oxygen, carbon dioxide, etc.) and anesthetic gases.

Licensed medical, dental or veterinary providers are not exempt from this program. A separate research registration is required.

The provider’s clinical license only allows the use of these products for patient care and does not cover use of these products for research purposes unless specifically approved as such by the DEA.

The first step in the process will be for the PI to attain a State of Florida exemption to use pharmaceutical grade substances for research. The exemption must be completed before starting the DEA registration. The registration form can be filed on-line with the Florida Department of Business and Professional Regulations (DBPR). There is no fee for this exemption.

The DBPR and DEA registration forms require very specific information, such as the address of the lab(s) where the products will be stored and used, including building and room numbers. For example, the use of “1600 SW Archer Road” is too generic for these forms - it does not designate specific building and rooms where the drug products will be used.

This exemption number will need to be provided to vendors, such as UF’s gas cylinder suppliers, prior to their deliveries. Without this valid exemption for medical grade gases or pharmaceutical products, the vendors cannot deliver any gas cylinders, veterinary drugs, etc., to the PI’s labs. There are no special exceptions or allowances to these rules.

If the lab is not using a DEA controlled substance, the PI does not need to apply for the DEA registration. The exemption and registration process is complete.

The time frame to obtain this exemption number is approximately 2-3 weeks.

Once the DBPR exemption number is received, the PI can start the process of obtaining the DEA registration. Researchers will use the online 225 application for their registration. “Researcher (I)” is applicable to the use of Schedule I controlled substances, while “Researcher (II-V)” is applicable to the use of Schedule II through V controlled substances. Click this link to access the full list of DEA controlled substances.

UF researchers are exempt from the DEA registration fees. Please enter the PI’s department chair or dean’s name under the "official's Name" on the application. Additionally, the DEA application will ask for a “state license” number. There is no state license number in Florida, therefore enter the exemption number and expiration date where the state license number is requested.

The time frame needed for the DEA registration process is typically two weeks. However, depending on the circumstances, it can take up to 6 weeks. Following the online submission of the application, a telephone interview with a DEA investigator will occur to gather more specific information. The DEA investigator will also review the specific security and paperwork requirements with the PI. On rare occasions, the DEA will do an announced site inspection prior to the registration being granted. Please note that the DEA will conduct a pre-registration inspection for all Schedule 1 applications.

Once the FL exemption letter and DEA registration are both received, a copy of each must be emailed to EHS Lab Safety (LabSafety@ehs.ufl.edu). Ensure that the originals are filed in a secure location where they can be easily accessed in the event of an inspection.

  • If any changes occur with the use of the pharmaceutical products, such as deleting the use of one or more product, or if the lab moves locations where they will be used (even if within the same building), the PI will be responsible for amending the DEA registration and DBPR exemption. Failure to do an amendment is a potential felony under the DEA regulations.
  • To update the DBPR exemption letter, notify the contact person included at the bottom of the original exemption letter.
  • If the PI or lab is moving from UF to another university, the drug products cannot be moved and must be disposed of appropriately.
  • The PI can modify the DEA license through the Office of Diversion Control website. A DEA investigator will contact the PI to verify the changes. The PI does not need to amend a registration if different staff is authorized (or withdrawn) to use the drug products or if a different vendor is used for supplying the products.
  • The DEA regulations do allow PIs to have two valid registrations at one time. To have dual registrations, it is strongly suggested that the PI contact the DEA for their assistance. It is important to note that DEA Controlled Substances cannot be transported from one registration site to the other. The multiple sites are considered “coincidental activities” and both sites must be considered independent from each other. Each site must have complete, independent sets or records .

Both the FL DBPR exemption and DEA registration expire. PIs must keep track of the expiration dates of these required documents. DO NOT let either of these expire. Potential penalties for expired registrations are severe, and may include prison time and/or criminal fines.

The FL exemption letter is valid for two years and DBPR does not send out renewal reminders. The DBPR requires receipt of an updated renewal form 30-60 days prior to the expiration of the exemption.

The US DEA registration is valid for one year and must be renewed annually. The PI will be contacted via email by the agency, usually three months prior to its expiration, to renew it. The DEA sends only one reminder.

If the PI allows the registration to expire and then renews or reapplies, the drug products purchased under the previous registration will not be covered under the new registration. The products purchased under the earlier registration cannot be used or disposed of under the new registration. The PI will need special permission from the DEA to dispose of these products.

A PI may formally authorize specific staff members under his/her control, or a co-investigator on the research project, to have access to the regulated pharmaceutical substances, including controlled substances regulated by the DEA. The EH&S Controlled Drug Authorized Access Form documents such permissions. Completed authorization forms are kept by the PI for the length of each individual’s employment (or for co-investigators, the duration of their project affiliation) plus an additional 3 years

All of the following record-keeping forms must be maintained and be readily available for inspection. All records must be kept for a minimum of three years.

Security Records

Authorized Personnel Log

List each person (e.g., PI, lab personnel) allowed to handle controlled substances for research use as an authorized agent or authorized personnel. 

  • Include a date range for the authorization.
  • This does not need to be sent to the DEA. Maintain it in an easily accessible secure location.

Inventory Records

Initial Inventory

Record controlled substances at a new storage location (including transfers and changes of address) immediately upon receipt of a DEA registration.

  • Each bottle received will need to be numbered or individually identified.
  • If the product is a Schedule I or II (C-I or C-II) use the DEA 222 form to log this into the lab as an initial inventory.
  • Schedule III-V substances are logged separately from Schedule I and II.
DEA Biennial Inventory

List all of the controlled substances currently stored at the DEA registered location. 

Perform every two (2) years after initial inventory.  Keep the completed biennial inventory with the controlled substance records
General Inventory Log

Summarize the usage of a controlled substance from the time of acquisition to the end of use (e.g., administration and/or disposal), including recording expired or damaged controlled substances.

  • If the staff has diluted a product for use, and uses it all during one application, there is no need to create an inventory for that dilution.
  • If any diluted material remains for intended use later, a new inventory page must be created, as it is considered a “new product” and dilution. The Diluted Solution Log can be used.

Document any discrepancies for losses of the product:

  • Human error in aliquoting and dispensing products
  • Inaccurate calibration of syringes
  • The small amount of product left in the syringe’s hub and in the hollow bore of the needle
  • Inaccurate volume of the products in their original bottles. Example: a 50 ml bottle may actually contain 48 or 53 mls. Due to sterility issues, it is not recommended that lab staff check this initial volume when bottles are received.
Diluted Solution Log

If any diluted material remains for intended use later, document the usage details including the:

  • Amount withdrawn
  • Waste amount (if applicable), and
  • Remaining balance through final disposal
Closing Inventory

List the controlled substances stored at a registered location upon the closing of that location.  

May use the General Inventory Log, but clearly label it "Closing Inventory

Purchasing & Theft/Loss

Purchasing Records Once the lab orders the exempted and registered products, all vendor records must be kept on file for inspection. This includes all orders, shipping and receiving forms
DEA Form 106 Theft/Loss (online submission)

Submit an online report within one (1) day of significant loss/theft:

  • Report to UFPD (392-1111)
  • Complete form after notifying Orlando Diversion Office (800-667-9752)
  • Must be completed by the DEA registrant

The Florida DBPR does not stage inspections of researchers who have been granted an exemption for using pharmaceuticals in research. Researchers must use, store, and dispose of these materials per the various regulations.

The DEA Diversion Control Officers may make unannounced inspections at any time to any registration holder. The officers may also complete an inspection of the labs prior to granting a registration and will always inspect any lab requesting the use of a Schedule 1 (C-1) controlled substance. EHS Lab Safety will notify all DEA registration holders of which day the Diversion Control Officers plan to inspect UF spaces and all registration holders must be on campus in the event they get selected for an audit. EHS has no prior knowledge of which labs will be inspected.

During the inspection, EHS Lab Safety staff can provide assistance answering questions &/or concerns about the UF policy and guidelines.

Diversion Control Officers will request to meet with the PI. If the PI refuses to do the inspection at the time, the Diversion Control Officers can get a court warrant to conduct the inspection. If the Diversion Control Officers arrive at the lab and the PI is not immediately available, they will wait for a short period of time prior to starting the inspection. If the PI is not on campus, he/she may be contacted via telephone to give the lab staff verbal permission to sign the DEA Notice of Inspection form. The DEA officials will ask for both the PI’s and staff’s UF ID and driver’s license

Pre-granting Inspection

The DEA officials will need to see the following:

  • Proposal of the research
  • Who will be authorized for use
  • CVs for all staff involved with the research
  • List of suppliers, as they need to ensure the suppliers have a DEA registration for those products
  • How the ordering process will be done
  • How the products will be received into the department or lab and who will sign for them
  • A summary of the labs proposed scientific process
  • Explanation of how the products will be secured
  • The location where the products will be secured
  • How other drugs have been handled (if the PI has had a registration for a different drug).

General Use Inspection

The record keeping portion of the inspection includes:

  • The PI’s original copies of both DBPR exemption letter and DEA registration
  • All copies of the purchase orders sent to vendors to order the pharmaceutical products.
  • All copies of the delivery receipts.
  • All of the inventories for each bottle, even ones that have been used up and disposed of.
  • Signature forms of all authorized staff that have or have had access to the products.
  • All disposal records, including all forms going to the disposal vendor, their mailing receipts and disposal certifications.
  • All records of theft or loss of a controlled substance.

Additionally, inspectors will request:

  • Experimental summaries for the studies the drugs will be used for.
  • The PI’s CV. This is so they can get an idea if the PI has the experience and knowledge to be using the products in research.

The Diversion Control Officer observes how the products are secured, where keys are kept, etc. They may also wish to see where the drugs are used. Inspectors do not normally enter an Animal Care facility on campus.

If the Diversion Control Officers notice any issues, they will discuss them with the PI and staff and will work with them to get issues corrected onsite. If the situation does not allow for this, the PI will need to correct the issue and send a letter of compliance to the Diversion Control Officers .
At the end of the inspection, a verbal summary will be provided to the PI and the staff about the Diversion Control Officer’s observations. If any non-compliance issues are found during the C-1 inspection, a written letter will also be sent to the PI.

EHS and IACUC will also conduct periodic inspections of DEA registration holders. These inspections are aimed at helping the PI and lab staff in maintaining their compliance with the associated rules and regulations regarding the use, storage and disposal of these controlled substances. Any deficiencies found by either UF EHS Lab Safety or IACUC must be rectified immediately.

Neither the PI nor her/his authorized staff can transport these products from one location to another if neither location is on the PI’s registrations. The PI and authorized staff cannot transport controlled substances to a different location and give it to a non-registered individual to use. This will constitute illegal trafficking of the products and the PI may be subject to fines and imprisonment.

Labs and individuals cannot dilute any controlled substance to a lower concentration to eliminate the need to have any product registered. This would be considered “manufacturing” of the substance and is not allowable under the law. Once a product is a DEA controlled substance, it is always a DEA controlled substance, regardless of how the lab alters or dilutes it.

There are certain diluted substances available for purchase that have been approved by the DEA for vendors to sell at a very low concentration for use as a testing standards without the need of a DEA registration. Labs cannot make their own diluted standards to avoid the DEA regulations.

A PI cannot give her/his DEA controlled substances to another PI to have it compounded, diluted, tested, etc. This would be considered manufacturing by an unregistered individual and would be punishable by fines and prison.

The PI will be responsible for disposing of any leftover drug products or products that have expired through a reverse distributer. The PI who owns the products may not give them to another PI.

If the lab is closing or the PI is retiring, the PI must dispose of those controlled substances prior to closing the lab or before allowing the DEA registration to expire. Abandoning them is a violation of the DEA regulations and the PI who owns them may be subject to punishment which may include fines and imprisonment.

EHS Hazardous Materials Management (HMM) cannot take possession of DEA controlled substances. PIs must contact one of the reverse distributor vendors listed in the EHS Hazardous Materials Handling web page. The PI must have a valid DBPR exemption and DEA registration to dispose of these products. DEA registrants must maintain a copy of the disposal information for a minimum of 3 years. The DEA registrant will be responsible for any and all costs of disposal of DEA controlled substances as billed by the vendor.

If the products to be disposed of are other types of non-controlled pharmaceuticals, list them on the EHS Hazardous Materials Management pick-up form as would be done for other chemical wastes. These products will be picked-up and disposed of by EHS HMM. Please contact Environmental Health and Safety at 352-392-1591 or labsafety@ehs.ufl.edu for questions or concerns.