Pharmaceutical Products and DEA Controlled Substances

Policy for the Use of Pharmaceutical Products and
Drug Enforcement Agency Controlled Substances in
Research Programs

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.

AUTHORITY

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

POLICY

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

RESPONSIBILITIES

Principle Investigator (PI)

Any PI of a lab at UF will be ultimately responsible for all aspects of the use, storage, disposal and all associated recordkeeping of these pharmaceutical products, even if the handling and use had been delegated to lab staff. PIs will need to provide the authorization for use of these products to their lab staff. Staff training will be the responsibility of their PI. PIs will be responsible for attaining and renewing both the State of Florida exemption for use of pharmaceutical products in research and the DEA registration (if required). It is the PI’s responsibility to have all paperwork available for immediate review by an inspector. Lastly- the PI will need to be sure to provide the security needed for the storage of the product(s). This may include the need to purchase strong boxes or safes.

Research Scientists and Lab Staff

Lab staff will be the PI’s “authorized users” and will be responsible for the use, handling, storage and disposal of these products as directed by the PI. The PI will most likely delegate all responsibilities for maintaining all paperwork for the use, handling, storage and disposal of these materials to lab staff.

Environmental Health and Safety

The EHS Laboratory Safety staff will be responsible to aid all researchers and PIs maintain compliance with the program through training sessions, guidelines, consultations and inspections. Lab Safety staff will also escort the DEA inspectors during their inspections of labs and act as a liaison between the inspectors and the PI or lab staff.

Policy#: UFEHS-LS001- 10/11/13
History: Originated 10/11/13


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 the Principal Investigator (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. 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.

List of DEA Controlled Substances

This will be an inclusive program for all pharmaceutical products being used in research by researchers including PhD, MD, DO, DVM, DDS, etc. Licensed medical, dental or veterinary providers are not exempt from this program as the provider’s licensure only allows the use of these products for patient care, and does not cover use of these products for research purposes, unless specifically approved by the DEA.

GETTING STARTED WITH PAPERWORK

State of Florida Exemption

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 registration form can be found on-line with the Florida Department of Business and Professional Regulations (DBPR). It can be found in the lower right side of the webpage. Please print it and mail, fax or email a scanned copy to the address at the bottom of page 4 of the website below. There is no fee for this exemption. The time frame to obtain this exemption number is approximately 2-3 weeks.

http://www.myfloridalicense.com/dbpr/ddc/exemptions.html

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. This requires building and room numbers to be entered. The use of “1600 SW Archer Road”, for example, is too generic for these forms, as it is the address of the UF Health Center, and does not designate specific building and rooms where the drug products will be used.

Please be as specific as possible when completing the form. Section V.3 will require a detailed explanation of the research being done with the drug products. Sections V.4 and V.5 will require a list of the drug products that will be bought and the vendor information.

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.

The DBPR exemption is valid for two years, and it will be the PI’s responsibility to keep a current exemption. The exemption must be maintained and renewed as long as the pharmaceuticals are in their lab, whether they are being used or not. If the exemption expires, it will need to be reapplied for. If anything changes with the lab’s location, use, products, etc., the PI must amend it as needed. If the PI’s exemption expires or is not modified as required, this will potentially be a violation of Florida statutes, as a PI cannot have the pharmaceutical products in their possession without a valid exemption.

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

DEA Controlled Substances Registration

Once the DBPR exemption number is received, the PI can start the process of obtaining the DEA registration. The DEA website application for registration has the electronic forms required. Researchers will use the online 225 application for their registration. The DEA application will ask for a “state license” number. There is no state license number in Florida, so enter the exemption number and expiration date where the state license number is requested.

UF researchers are exempt from the DEA registration fees. The application will ask for an “official’s” name. Please enter the PI’s department chair or dean’s name. The DEA will potentially contact them to confirm the PI is truly a researcher at UF and to ensure that the PI is doing the research that requires the use of the controlled substance.

The time frame needed for the DEA registration process is typically two weeks but can possibly extend up to 6 weeks, depending on the circumstances. It will involve the online submittal of the application and then telephone interviews with a DEA investigator to gather more specific information. The DEA investigator will also review the specific security and paperwork requirements with the PI. On rare occasions, DEA will do an announced site inspection prior to the registration being granted, but please note that the DEA will conduct a pre-registration inspection for all Schedule 1 applications.

Once the exemption and DEA registration are both received, ensure that they are filed in a secure location where they can be easily accessed. EHS Lab Safety and IACUC (Institutional Animal Care and Use Committee) will need to review these during the annual Lab Safety and IACUC site surveys. UF IACUC is now requiring EHS Lab Safety to have a copy of the DBPR exemption and the DEA registration. Please forward copies of these to EHS Lab Safety.

Amending the DPBR Exemption or DEA Registration

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, 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.

If the lab changes locations (labs within the same building or a different building) where the products will be used, the PI must send an addendum to both the DBPR and DEA with the expected move date. The registration is specific to the labs in which the controlled substances will be used and stored. Without this amendment, the PI will be in violation of the regulations and subject to fines and possible imprisonment.

If the PI or lab is moving from UF to another university, the drug products cannot be moved. It would be easier for the PI to dispose of all drug products before the move and buy new once at the new location and the new DEA registration for the new university is obtained.

The DEA regulations do allow PIs to have two valid registrations at one time. To have duel registrations, it is strongly suggested that the PI contact the DEA for their assistance with this. 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 sets of purchase, use, dilution and disposal recordkeeping.

The PI can modify the DEA license via their website. No letter to the DEA is required. Go to the Office of Diversion Control website, click registration, click registration tools, and then click registration changes. Enter the changes as needed. 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.

FL DBPR EXEMPTION AND DEA REGISTRATION RENEWALS

Both the FL DBPR exemption and DEA registration do expire. The FL DBPR is valid for two years and DBPR does not send out reminders about the need to renew. The DBPR will require an updated renewal form to be sent to them 30-60 days prior to the expiration of the exemption. It is strongly suggested that all PIs mark a calendar as to the expiration dates of these required documents.

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

DO NOT let either of these expire! If either expires, the PI will need to start the process all over again. This unfortunately will also put the PI into a state of non-compliance with the Federal regulations. The PI or researchers will not be able to use, buy or dispose of any DEA products without a valid registration. The PI will potentially be in felony violation of the DEA regulations, as the lab will be in possession of DEA controlled substance that the PI would not have a valid registration for. Penalties for this could be severe, and may include prison time and/or criminal fines.

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, but the PI is still responsible to secure them, even though they cannot legally have them. The PI will need special permission from the DEA to dispose of these products.

AUTHORIZED STAFF

The PI will grant permission to select members of the lab’s staff to have access to the drug products so they can perform their research projects. The PI will need to grant them this permission by completing the Authorized User form. The authorized staff will have to complete the two question form and then sign the form. The PI will also need to sign the form. These will need to be kept readily assessable in the lab’s files. The PI will need a form for each of the authorized lab staff who have access to the drug products. These records will need to be kept for three years.

Please note that the PI cannot authorize anyone who is not directly reporting to them to use the DEA products they are registered to use. Therefore, the PI with the registration cannot allow another PI or their staff to use or buy products under the registration unless the registered PI is in a direct supervisory role of these individuals or are working as a co-PI on a research project.

RECORD KEEPING

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

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.

The DEA uses the designation of “C” as the schedule symbol. Example: “C-I” = schedule one products.

Inventories: Each bottle received will need to be numbered or individually identified. A log sheet must be started for each bottle as soon as they are received. 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 and as an initial inventory. These pre-populated forms will be sent to the lab when the registration is granted. All other scheduled products will not have the DEA 222 form to complete. Log each bottle onto the individual form with the date received, date opened, date emptied and date it was disposed of (if applicable). Continuing Record for Acquisition and Disposition of Controlled Substances form C-II drugs use should also be logged onto the Drug Record  – C-II form.

C- III, C- IV or C-V drug products can use the same inventory form, which is separate from the C-I or C-II forms. Drug Record – C-III-V form

Bi-annual inventory: A full inventory of all DEA controlled substances must be completed every two years. Any product that is in the lab at that time must be inventoried, even if it has not been in the lab’s possession for the full two years. Biennial Inventory of C-II Controlled Substances form

Diluted materials: 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 at a later date, a new inventory page must be created, as it is considered a “new product” and dilution.

Waste bottles: If the lab makes a dilution of the product and does not use all of it in their work, the remaining portion is now considered waste. A new inventory form for the dilution must be initiated and kept for any amounts of that same dilution. Lab staff cannot add different dilutions to this waste bottle.

If any controlled substance has been stolen, misplaced or lost from the lab staff’s control, it must be reported to the UF Police Department (392-1111) and to the DEA. The DEA form DEA-106 must be used for this.

Lab staff must also document any discrepancies for losses of the product through issues of the following.

  • Human error in alloquoting 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.
  • These discrepancies should be documented on the inventory sheets for the bottle.

INSPECTION

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 from the Orlando office may make unannounced inspections at any time to any registration holder. This could be for any researcher, no matter what schedule drug product they use. The officers may also do an inspection of the labs prior to granting the registration to the PI. DEA Officers will always do an inspection for any requested Schedule 1 (C-1) controlled substance.

EH&S Lab Safety and the Orlando DEA office have an agreement where the DEA will inform Lab Safety when they plan on coming to Gainesville for an inspection. They will not tell this office who they will be inspecting. As Lab Safety will not know who the DEA plans to inspect, this office will send a mass email to all DEA Registration holders to try to affirm if they will be on campus the day of the proposed DEA visit. Lab Safety will provide this information to the DEA. The reasoning behind this process is to ensure the PI who will be inspected will be on campus and the DEA will not waste the trip to campus.

EH&S Lab Safety will escort the inspectors, but we will have no prior knowledge of which lab they will inspect until we leave our office to inspect the labs. UF EH&S will not be able to give any PI notice of any impending inspection to their labs. During the inspection, Lab Safety staff will act as observers and counselors and will be able to help answer questions or concerns about the UF policy and guidelines.

It is important to note that once the inspectors are at the labs, they will ask to meet with the PI. The PI may refuse an inspection or ask for an appointment for an inspection at a different time. This may be granted if the PI has special circumstances. If the PI refuses to do the inspection at the time, the inspectors can, and will, get a court warrant to conduct the inspection. This may happen within hours of the initial refusal by the PI. Once that occurs, the inspection will be more adversarial and will be much stricter.

If the inspectors 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, but can contacted via telephone to give the lab staff verbal permission to sign the DEA Notice of Inspection form, the DEA inspectors will do the inspection.

The inspection will start with the inspectors showing their IDs. The PI and staff may look at it, but they will not be allowed to touch or photocopy the IDs. After credentials are shown, the Notice of Inspection will need to be reviewed and signed by the PI, or the designee for the PI. The DEA officials will ask for both the PI’s and staff’s UF ID and driver’s license and they will take information off of those documents. The inspection will start immediately after IDs and credentials are shared and examined.

For a 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).

For a general use inspection, they will first want to inspect all record keeping. This will include the following (and is typically going to be in the following sequence to follow the drug purchase, use and disposal).

  • 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.
  • 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 inspectors will then want to see how the products are secured, where keys are kept, etc. They may wish to see where the drugs will be used, but if it is in an Animal Care facility on campus, they most likely will not go into those areas.

If the inspectors observe any issues, they will discuss them with the PI and staff and will work with the PI and lab staff to get things corrected while they are 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 inspectors.

At the end of the inspection, a verbal summary will be provided to the PI and the staff about the inspector’s observations. If any non-compliance issues are found during the C-1 inspection, a written letter will also be sent to the PI at a later date.

EH&S and IACUC will also do periodic inspections of DEA registration holders. Lab Safety will do this during the annual Lab Safety Survey of the labs. The Lab Safety Surveyors will look at all paperwork, storage areas, etc. IACUC will do its inspections during the semi-annual inspection cycles. 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.

CONTROLLED SUBSTANCE HANDLING AND TRANSPORT

Neither the PI nor her/his authorized staff can self transport these products from one location to another if neither location is on the PI’s registrations. The PI cannot make a solution and transport it 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, etc. This process and dilution has been vetted through the DEA for that purpose and the substances would not require a DEA registration for use. 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.

DISPOSAL

The PI will be responsible for disposing of any leftover drug products or products that have expired and will not be used. 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. Just abandoning them for someone else to deal with is a violation of the DEA regulations and the PI who owns them may be subject to punishment which may include fines and imprisonment.

UF Environmental Health and Safety Hazardous Materials Management cannot take possession of DEA controlled substances. It is suggested that PIs contact one of the vendors listed in the EH&S Hazardous Materials Handling web page. The PI must have a valid DBPR exemption and DEA registration to dispose of these products. The vendors will ask that various forms be completed and submitted for their approval. Once the forms are accepted, the vendor will send shipping boxes for the PI to send the products to them for their disposal. The PI will receive a copy of the disposal information that must be kept in the files for a minimum of 3 years. The PI will be responsible for any and all costs of disposal of DEA controlled substances as billed by the vendor.

In rare cases where a drug has been abandoned due to the death of the PI holding the registration or other unforeseen circumstance, EHS will work with the department and the DEA to dispose of the product. Special permission must be granted by the DEA for this disposal to occur. This scenario is very rare and costly to the University, so it is most strongly recommended that control of all DEA products be strictly observed while they are in the possession of the PI.

If the products to be disposed of are other types of non-controlled pharmaceuticals, list them on the EH&S Hazardous Materials Management (HMM) pick-up form as would be done for other chemical wastes.  These products will be picked-up and disposed of by EH&S HMM.

If anyone has any questions or concerns with the University of Florida’s use and disposal of pharmaceutical and DEA controlled substances, please contact Environmental Health and Safety at 352-392-1591 or labsafety@ehs.ufl.edu.