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Controlled Substances in Research and Instructional Use

The University of Texas at Brownsville (UTB) requires all individuals conducting activities with Drug Enforcement Agency (DEA) controlled substances be registered with the DEA, Texas Department of Public Safety, and U.S. Food and Drug Administration (where appropriate) and comply with state and federal regulations regarding the acquisition, storage, use and disposal of those substances.

I. Registration

Both the state and federal law classify controlled substances into five categories according to their medical use and potential abuse. For example, Schedule I substances are categorized as having no medical value and having the highest potential for abuse. Schedule V is categorized as having the least potential for abuse.

Registration forms are available on the web at www.deadiversion.usdoj.gov and www.txdps.state.tx.us/csr/.

A. Research Use

Every person conducting research activities with a controlled substance is required to register with the Drug Enforcement Agency (21 CFR 1301.21 or instructions on application Form 225). For Schedule II-V Substances, complete and submit DEA Form 225 or DEA 224 (see Instructional Use below). For Schedule I Substances, in addition to DEA form 225, the applicant is required to submit three copies of the research protocol (see 21 CFR 1301.18 or instructions on application Form 225).

B. Instructional Use

Every person conducting instructional activities with a controlled substance is required to register with the Drug Enforcement Agency (21 CFR 1301.11). For Schedule II-V Substances, use DEA Form 224 to register (can be used for both research and instructional activities). Re-registration is required every three years. State employees are exempt from the registration fee (see 21 CFR 1301.21).

C. Notes

  • For Schedule I substances, a copy of the DEA Application and research protocol must be submitted to EH&S. Following review, EH&S will provide institutional approval as appropriate.
  • DEA Form 222 must be used for procurement of Schedule I and II substances (Order DEA Form 222 by checking ‘Indicate here if you require order form books’ on application form).
  • On August 12, 1999, Ketamine was included into the Federal Drug Enforcement Regulations. Purchase, use and disposal of Ketamine requires a Schedule III permit.

II. Employee Screening Procedure

The registrant is responsible for managing the controlled substance in accordance with the requirements of the regulations including inventory, record keeping and security provisions. Agents of the registrant may engage in approved activities under the direction of the registrant. The registrant is required to screen those employees prior to authorization. As part of the screening process, a questionnaire which includes the following questions (21 CFR 1301.90) must be completed for each non-practitioner having access to DEA controlled substances:

  • Within the past five years, have you been convicted of a felony, or, within the past two years, any misdemeanor, or, are you presently charged with committing a criminal offense?
  • In the past three years, have you knowingly used narcotics, amphetamines or barbiturates other than those prescribed to you by a physician?

Fill out one questionnaire for each employee (non-practitioner) who is authorized by the registrant to handle DEA controlled substances under his or her direction.

III. Record Keeping

To ensure accountability, a complete and accurate continuing record (e.g. real-time inventory) is required for each substance and must be maintained on a current basis. Continuing records should be kept for two years after the substance is spent. Inventories and records of Schedules I and II shall be kept separately from all other records maintained by registrant. Similarly, inventories and records of controlled substances in Schedules III, IV, and V must maintained separately from all other forms maintained or in a form that they are readily retrievable from the ordinary business records of the registrant. It should include:

  • Date of receipt
  • Name of the substance
  • Each finished form of the substance (e.g. 10 mg tablet or 10 mg concentration/mL.)
  • Number of units or volume of each finished form in each container
  • Number of containers of each finished form (e.g. six 3-mL vials)
  • Date of dispensing, units or volume dispensed, units or volume remaining in container, name or initials of the individual who dispensed or administered the substance
  • If substance is acquired from, or distributed to another person, their name, address and DEA registration number must be recorded along with date and number of units acquired or distributed
  • If substance is disposed of, include date, manner of disposal, and quantity of substance disposed (Keep disposal records for at least two years)

After initial inventories of controlled substances in Schedules I - V are taken, the registrant shall take new inventory of all controlled substances on hand at least every two years. Each inventory shall include:

  • If inventory was taken at the beginning or closing of business
  • Name of controlled substance
  • Each finished form of substances (e.g. 10 mg tablet or 10 mg concentration/mL)
  • Number of units or volume of each finished form in each container
  • Number of containers of each finished form (e.g. six 3-mL vials)
  • Disposition of the controlled substance

Damaged, defective, expired or impure substances awaiting disposal must also be inventoried including name, total quantity, and the reason why the substance is being maintained.

After the initial inventory, a new inventory must be taken at least every two years. The biennial inventory date must be within two years of the last inventory. Inventories and records for Schedule I and II substances are required to be maintained separately from all other records of the registrant. Records and inventories of all controlled substances must be maintained at the registered location.

Inventories (biennial and real-time/continuing records) and other records including copy of certificate of registration, purchase orders, copy of DEA Form 222 (if applicable), loss records and screening questionnaires must be kept at the registered location and made available to EH&S and research compliance officer for review.

IV. Security

Registrants shall provide effective controls to guard against the theft or diversion of controlled substances. Substances are required to be stored in securely locked, substantially constructed cabinets or safes (i.e. not easily broken into or moved; see 21 CFR 1301.71)

Registrants are required to report any significant loss or thefts to the local DEA office by using DEA Form 106 and contact Campus Police and EH&S for further assistance. Thefts must be reported whether or not the controlled substances are subsequently recovered and/or the responsible parties are identified and action taken against them.

V. Disposal

All DEA controlled substances must be accounted for upon their disposal. Please, contact EH&S 956-882-5930 for information concerning the disposal of Schedule I-V DEA controlled substances. A current certification of registration will be required. Keep all disposal records for at least two years.

VI. Surveillance

As a service, EH&S will survey all controlled substance researchers annually to assist with verification of recordkeeping, security and disposal. A list of all registrants will be requested annually with the assistance of Campus Police at 956-882-2222 and the DEA. Any changes to researcher status can be reported to EH&S at 956-882-5930.

For more information, you can also contact the Office of Environmental Health & Safety at 956-882-5930.

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