Policy No: 2079 Responsible Office: Research and Economic Development Last Review Date: 10/31/2022 Next Required Review: 10/31/2024
Non-medical Controlled Substances Research
Many substances may only be used for legitimate medical and scientific research purposes and all other uses are illegal. The federal Controlled Substance Act (21 USC Chapter 13) regulates such use and requires users to be registered. Federal regulations for implementing this statute are promulgated in 21 CFR 1300-1399 and are enforced by the U.S. Drug Enforcement Administration (DEA). These regulations require legitimate users of controlled substances to register with the DEA and comply with requirements pertaining to secure storage, recordkeeping, inventorying, reporting loss, theft, or abuse, and safe disposal.
The purpose of this document is to regulate and prevent the diversion of controlled substances used in the conduct of non-medical research activities at University of South Alabama (USA) and, by clarifying responsibilities, facilitate the process for the investigator.
The scope of this document extends only to controlled substance licensees/registrants engaged in non-medical research activities at the University of South Alabama.
Authorized Personnel: A University employee authorized to use controlled substances by a DEA Registrant who also serves as the employee's direct supervisor.
Controlled Substances: A controlled substance is generally a drug or chemical whose manufacture, possession, or use is regulated by a government, such as illicitly used drugs or prescription medications that are designated by law. Controlled substances are divided into five categories, known as Schedules by 21 USC §812. Schedules are based on whether the substances have a currently accepted medical use in treatment in the United States, their relative abuse potential, and likelihood of causing dependence when abused.
DEA Registrant: A University employee who holds a DEA registration and is responsible for ordering, storing, using and disposing of controlled substances.
4. Policy Guidelines
USA employees conducting activities with DEA controlled substances must be registered with the DEA and are responsible for complying with relevant state and federal regulations regarding the acquisition, storage, use and disposal of those substances. Registrants must first provide notification of intent to register with the USA Office of Information Security and Risk Compliance (OISRC) by email at firstname.lastname@example.org.
Registrants may authorize non-registered agents (definition of “authorized personnel”) to engage in controlled substance activities on their behalf. Laboratory employees can be considered authorized personnel of the registrant if they are acting in the usual course of their business or employment. The activities, including the administration of controlled substances, must be delegated by the licensee/registrant to the authorized user in writing and kept in a designated user log (Drug Usage Form).
4.1.1 DEA Registrants must:
- Must obtain and maintain a current DEA registration whenever controlled substances are being used;
- Notify and report their DEA registration number to OISRC by email;
- Require any person that handles controlled substances to complete a DEA-based questionnaire;
- Keep a record of the questionnaire until that person no longer handles controlled substances;
- Authorize the purchase, use, and disposal of controlled substances;
- Maintain an accurate list of authorized users of controlled substances;
- Supervise the use of controlled substances;
- Conduct a physical inventory of controlled substances annually with documentation following guidelines detailed in section 5.7;
- Maintain all records for at least three years; and
- Report any volume discrepancies to OISRC.
4.1.2 Authorized Personnel must:
- Complete and submit the DEA-based questionnaire to the DEA Registrant;
- Comply with the directions for using controlled substances given by the Registrant;
- Maintain accurate records of the acquisition, use, and disposition of controlled substances;
- Use proper personal protective equipment and adhere to safe practices while using controlled substances; and
- Report any volume discrepancies to the Department’s Registrant.
4.1.3 Office of Information Security and Risk Compliance (OISRC) must:
- Assist individuals who wish to engage in research with controlled substances in obtaining a DEA registration number;
- Educate researchers on the applicable rules and regulations for use, storage, and disposal of controlled substances;
- Maintain physical records of all DEA registrants and their purchases/acquisitions of CS;
- Assist DEA registrants with disposal of expired CS or excess CS upon project termination and document disposal;
- Verify DEA registrants have completed required DEA training; and
- Investigate all discrepancy reports and make determination whether discrepancy requires report to DEA.
4.1.4 Office of Research Compliance and Assurance must:
- Provide compliance oversight through inspections in coordination with OISRC.
4.2 Penalties for Controlled Substance Violations
The DEA can impose administrative, civil, and criminal actions against a controlled substance licensee and DEA registrant for noncompliance and/or theft or loss associated with storage, administration, recordkeeping, and other aspects of controlled substances.
Failure to comply with USA non-Medical Controlled Substance Research Policy, state regulations, or federal regulations may result in terminating your Controlled Substance Authorization and may also result in the suspension of controlled substance orders. If the failure to comply results in a violation of DEA regulations, the DEA will be provided notification of the non-compliance and the violation.
USA faculty or staff wishing to obtain controlled substances must register with the Drug Enforcement Administration. Different activities have different registration requirements. Forms and detailed instructions are available on the DEA website. The required forms are as follows, according to activity:
- For research and chemical analysis: Form 225. To renew an existing registration, use Form 225A;
- For the shipping address, the applicant should use the address for the Office of Information Security and Risk Compliance (5840 USA Drive South, Mobile, AL 36688);
- During the DEA application process, the applicant should identify as a government employee in order to receive a fee exemption. The USA Authorizing Official for this purpose is the OISRC. Please call OISRC directly to obtain the official contact information for registration purposes;
- The applicant must have separate registrations for separate locations; and
- Notify the Office of Information Security and Risk Compliance (OISRC) upon approval of the controlled substance registration.
5.2 Authorized Use
5.2.1 The registrant is responsible for managing the controlled substances according to the regulatory requirements covering the following:
- Record keeping; and
- Security provisions.
5.2.2 Registrants may authorize laboratory employees (termed, “authorized users”) to work with controlled substances on their behalf. Approved activities, including the administration of controlled substances, must be delegated in writing by the registrant to the authorized user.
5.2.3 The registrant is required to screen employees before authorizing them to work with controlled substances. Screening is conducted as follows:
- Employees must complete a questionnaire (21 CFR, 1301.90). The registrant retains this questionnaire as part of their records (see 5.5 Record-keeping Requirements” for information on filing the questionnaire);
- Laboratory employees must undergo a criminal background check as part of the screening process; and
- Registrant’s department will support fees incurred for this service. After the employee completes the questionnaire (Section 3.a) the registrant submits to the Authorizing Official the name(s) of the employee(s) they wish to authorize. A criminal background check, consisting of local, regional, and federal inquiries, will be conducted by USA Human Resource Services (HRS).
5.2.4 Please note that IT IS A FELONY to provide a controlled substance to a person who is not registered with the DEA. Transfers of controlled substances can occur only between two DEA registrants. Transfers of schedule I or II controlled substances must be accompanied by a DEA form 222 completed by the registrant receiving the substance(s).
5.3 Employee Questionnaire
Employee Questionnaire must be included as part of the screening process before they are allowed to handle DEA-controlled substances.
5.3.1 The Registrant must have the following questions answered in writing by any authorized agents:
- Question. Within the past five years, have you been convicted of a felony, or within the past two years, of any misdemeanor or are you presently formally charged with committing a criminal offense? (Do not include any traffic violations, juvenile offenses or military convictions, except by general court-martial.) If the answer is yes, furnish details of conviction, offense, location, date and sentence; and
- Question. In the past three years, have you ever knowingly used any narcotics, amphetamines or barbiturates, other than those prescribed to you by a physician? If the answer is yes, furnish details.
5.3.2 Make copies of the Controlled Substance Questionnaire for Non-DEA license holders form for each employee who will be working with these substances.
5.3.3 Maintain these questionnaires on file with Registrant’s Department. The questionnaires will be kept on file for a minimum of seven years following the cessation of controlled substance activity.
5.4 Ordering Controlled Substances
To order controlled substances, the Registrant must first be registered with the DEA. The Controlled Substance Ordering Form, DEA Form 222, is a paper-based form. It is requisitioned directly from the DEA and is required to be filled out in triplicate. The DEA Form 222 also allows the exchange of controlled substances from one DEA registrant to another DEA registrant (typically used when a controlled substance is sent to a reverse distributor for credit or disposal).
Schedule I or II registrants can request the DEA Forms 222 online, upon which you will receive the maximum number of order form books allowed for your business activity. The link is: https://www.deadiversion.usdoj.gov/webforms/orderFormsRequest.jsp
Schedule III, IV, and V drug orders do not require a DEA Form 222. These substances can be ordered directly from the manufacturer. However, you may be asked to provide a copy of your DEA Registration before your order will be prepared and shipped.
The Registrant is responsible for accounting for each DEA Form 222 in their possession – this includes voided, used, and unused forms.
To fill in DEA Form 222 (§1305.12 Procedure for executing DEA Forms 222):
- A purchaser must prepare and execute a DEA FOrm 222 by use of a typewriter, computer printer, pen, or indelible pencil;
- Only one item can be entered on each numbered line. An item must consist of one or more commercial or bulk containers of the same finished or bulk form and quantity of the same substance. The number of lines completed must be noted on that form at the bottom of the form, in the space provided. DEA Forms 222 for carfentanil, etorphine hydrochloride, and deprenorphine must contain only these substances;
- Order forms for carfentanil, etorphine hydrochloride and diprenorphine may not contain requests for any other substances;
- The name and address of the supplier from whom the controlled substances are being ordered must be entered on the form. Only one supplier may be listed on any form. The supplier's DEA registration number may be entered by the purchaser or the supplier;
- Each DEA Form 222 must be signed and dated by a person authorized to sign an application for registration or a person granted power of attorney to sign a Form 222 under § 1305.05. The name of the purchaser, if different from the individual signing the DEA Form 222, must also be inserted in the signature space.
- Unexecuted DEA Forms 222 may be kept and may be executed at a location other than the registered location printed on the form, provided that all unexecuted forms are delivered promptly to the registered location upon an inspection of the location by any officer authorized to make inspections, or to enforce, any Federal, State, or local law regarding controlled substances.
5.5 Record-keeping Requirements
Maintain the following records at the registrant’s location as identified on the registration:
- Employee questionnaire and authorization records;
- Executed order forms;
- Inventory records (must be kept for a minimum of seven years from the date of record); and
- Drug dispensing records (must be kept for a minimum of seven years from the date of record).
A registrant who wishes to maintain records at a location other than the registered location must notify the DEA. Refer to 21 CFR 1304.04 for guidance.
5.6 Controlled Substance Tracking
For each container of controlled substances, tracking records must be kept that note every time that these substances are used. Every mL or mg of a controlled substance must be accounted for in the dispensing records. A Sample DEA222 Drug Control (Dispensing) Record is available from OITRC, for dispensing records. The control substance record should have an entry for each time material was removed from the container.
The Registrant is responsible for accounting for the total volume of the controlled substance issued to them (in accordance with 21 CFR §1304.22). When controlled substances are dispensed, a “CS usage record” will be issued with the CS. Please use this form to log ALL amounts administered for experiments or to log discarded doses. If any dose is discarded, because of contamination or error, two signatures (or two sets of initials) must be present next to the entry for the discarded amount. Please do NOT discard un-used controlled substances that remains in the bottle. Return to OITRC for proper disposal.
The “CS usage record” must be returned to OISRC or Department of Comparative Medicine when all of the drug has been used or when returning expired, un-used CS. If CS remains in the vial, the amount of CS remaining in the container MUST match the amount of the CS logged as remaining on the record.
5.7 Inventory Procedures
Each person registered to handle controlled substances must maintain an inventory. The inventory should be:
- Maintained at the registered location (unless a notification has been sent to DEA notifying that records will be maintained at a specific central location);
- Available for seven years after the using or disposing of the substance; and
- A physical inventory (See CFR Section 1304.11 for specific inventory requirements).
The information included in the inventory depends on whether the controlled substance is in finished form (i.e., commercially bought) or otherwise (for example, damaged, defective, or impure controlled substances).
5.7.1 For controlled substances in finished form (i.e. commercially bought), the inventory should include the following information:
- Name, address, and DEA Registration Number;
- Date the inventory was taken, noting whether it was at the beginning or end of the day;
- Name of the substance;
- The form of the substance (e.g. 10 milligram tablet or 10 milligram concentration per fluid ounce or milliliter);
- The number of units or volume of each commercial container (e.g. 100 tablet bottle or 3 milliliter vial);
- The number of commercial containers of each substance form; and
- Signature and date.
5.7.2 For each substance not listed above (i.e. for damaged, defective, or impure substances), an exact count of the dosage units must be made, or the container must be graduated to reflect its content, and inventory should include the following:
- Name, address, and DEA registration number;
- Date the inventory was taken and whether it was at the beginning or end of the day;
- Name of substance;
- Total volume of substance or total number of units (e.g. 50 10mg tablets);
- Reason the substance is being maintained by the researcher; and
- Signature and date.
Controlled substances must be kept in a securely locked, sturdy cabinet or safe that is secured to a wall or otherwise not removable. DEA inspectors will check to see if the cabinet is bolted to a permanent structure (e.g., a wall) and that the interior double lock compartment is bolted to the main cabinet.
DO NOT leave keys to the controlled substances cabinet in the lab. Keys allowing access to the controlled substances must remain in the possession of authorized users.
If there is a theft or loss of controlled substances notify OISRC, Office of Research Compliance and USA Police Department immediately. A DEA Form 106 must be submitted to the DEA within 24 hours.
5.9.1 Empty Vials
Empty vials of controlled substances should be disposed of through OISRC. Please contact the office for assistance. In addition, the disposal of the empty vial must be recorded in the respective inventory and dispensing records.
5.9.2 Expired Controlled Substances
Expired containers of controlled substances (with any contents remaining) must be separated from non-expired containers of controlled substances, and must be clearly labelled as being expired. The expired substances must remain in the locked controlled substance cabinet or safe. A DEA Registrant in possession of controlled substances that are expired or unwanted must contact the OISRC for the permitted disposal of the drugs. All controlled substances designated for disposal must remain in a secured storage location until they are packaged and consigned for disposal.
OISRC will make the determination if on-sight disposal is available or a reverse distributor must be brought in. If on-sight disposal is recommended OISRC will facilitate the disposal with the Registrant. The Registrant must maintain copies of the records documenting the transfer and disposal for a period of at least seven years after disposal of a controlled substance.
Failure to comply with USA Controlled Substance Research Policy, state regulations, or federal regulations may result in terminating your Controlled Substance Authorization and may also result in the suspension of controlled substance orders. If the failure to comply results in a violation of DEA regulations, the DEA will be notified of the non-compliance and the violation.
Failure to comply with the guidelines set out in this policy could result in loss of rights to conduct CS research, suspension of ongoing orders, and in cases of intentional violation of these guidelines, administrative sanction including suspension and/or termination of employment.
If the failure to comply results in a federal crime, a report to the DEA will be made.
7. Related Documents