Controlled Substance Policy

The objective of the UF Controlled Substances Policy is to ensure compliance with state and federal regulations governing the use of Drug Enforcement Agency (DEA) controlled substances.

Authority

Delegated to the Division of Environmental Health & Safety by the University President on October 10, 1991.

Policy

The University of Florida requires that all individuals conducting activities with DEA controlled substances be registered with the DEA and comply with state and federal regulations regarding the acquisition, storage, use and disposal of those substances.

Responsibilities

Each principal investigator or faculty conducting research and/or instructional activities with DEA controlled substances will be responsible for registering with the DEA and for assuring compliance with applicable state and federal regulations. The registrant may not allow the permit to lapse until all controlled substances are spent, disposed of, or transferred to another registered person.

The Division of Environmental Health & Safety will be responsible for assisting individuals in complying with applicable rules and regulations. This will include educating researchers about the requirements, assisting them as necessary during implementation, and providing regular oversight to insure compliance is being maintained.

B. GENERAL INFORMATION & PROCEDURES

1. 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

A. Research Use

Every person conducting research activities with a controlled substance is required to register with the Drug Enforcement Agency (21 CFR 1301.11). Re-registration is required annually. State employees are exempt from the registration fee (see 21 CFR 1301.21 or instructions on application Form 225).

For Schedule II-V Substances, complete and submit DEA Form 225 or DEA Form 224 (see Instructional Use below).

For Schedule I substances, in addition to DEA Form 225, the applicant is required to submit 3 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 12th, 1999, Ketamine was included into the Federal Drug Enforcement Regulations. Purchase, use, and disposal of Ketamine requires a Schedule III permit.

2. Employee Screening Procedure

The registrant is responsible for managing the controlled substances 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 3 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.

Employee Questionnaire

3. 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 2 years after the substance is spent. 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.)

Continuing Record

Initial and biennial inventories are required for Schedule I and II substances. An initial inventory shall include:

· Name of each 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).

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 & 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.

Initial and Biennial Inventory form

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 compliance officer review.

4. 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 (Orlando) by using DEA Form 106. 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.

5. Disposal

All DEA controlled substances must be accounted for upon their disposal. Follow EH&S Hazardous Materials Management instructions for disposal of Schedule I-V DEA controlled substances. Keep all disposal records for at least two years.

C. DEA PHONE NUMBERS & CONTACTS