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Controlled Substances Used in Non-Clinical Educational and Research Activities

15.99.99.Z1.03 (IP)

Approved December 1, 2004

Revised September 6, 2006

1. GENERAL

Due to their potential for abuse, items identified by the U.S. Department of Justice, Drug Enforcement Administration (DEA) as controlled substances are subject to extensive licensing, registration, storage, security, use, and disposal requirements. This institutional policy regulates the use of controlled substances, including controlled substance analogues, chemical precursors, controlled glassware used in non-clinical educational and research activities on the campuses of The Texas A&M University System Health Science Center (HSC).

2. DEFINITIONS

2.1 Controlled Substance is defined as a substance, including a drug and immediate precursors and controlled glassware, listed in Schedules I through V or Penalty Group 1 through 4 of the Health and Safety Code, Chapter 481, the Texas Controlled Substance Act.

2.2 Controlled Substance Analogue is defined as a substance with a chemical structure substantially similar to the chemical structure of a controlled substance in Schedule I or II or Penalty Group 1 or 2 of the Health and Safety Code, Chapter 481, the Texas Controlled Substance Act; or a substance specifically designed to produce an effect substantially similar to, or greater than, the effect of a controlled substance in Schedule I or II or Penalty Group 1 or 2 of the Health and Safety Code, Chapter 481, the Texas Controlled Substance Act.

2.3 Chemical Precursor is defined as a chemical specified by regulation of the DEA that may be used as a primary component in manufacturing a controlled substance. The list of regulated chemical precursors may be found in the U.S. Controlled Substances Act.

2.4 Controlled Glassware is defined as condensers; distilling apparatus; vacuum dryers; single, two-and three-necked flasks; distilling flasks; Florence flasks; filter funnels; Buchner funnels; separator funnels; Erlenmeyer flasks; round-bottom flasks; thermometer flasks; filtering flasks; Soxhlet extractors; and adapter tubes made of glass.

3. RESPONSIBLE PARTY

Any person with specific authority to purchase or accept controlled substances must bear full responsibility for establishing security measures regarding their purchase, acceptance, use, and ultimate disposal. Thus, if the controlled substances are to be used in a research program supervised by an individual faculty member, the principal investigator (PI) must assume full responsibility. If the controlled substances are to be used in conjunction with the activities in an organized research unit (e.g. centers and institutes) outside the operation of a specific sponsored project, the Director of the unit is responsible. If the controlled substances are to be used in a teaching laboratory or in a demonstration for an organized class, the Chair of the department through which the academic course is offered is the responsible party.

Health Science Center faculty and staff who use controlled substances, controlled substance analogues, and chemical precursors in their employment related activities must obtain and keep current federal Drug Enforcement Administration (DEA) and Texas Department of Public Safety (DPS) registrations, unless exempted by law. Registrants are responsible for procuring, maintaining security, keeping records, and disposing of controlled substances, controlled substance analogues, and chemical precursors in accordance with federal and state regulations and rules.

Each HSC component shall maintain an updated list of faculty and staff in possession of controlled substances, and the type of controlled substance each responsible party utilizes. Each HSC component shall also establish procedures for procuring, maintaining security, keeping records, inventory control, and disposing of controlled substances, controlled substance analogues, and chemical precursors, and chemical glassware.

4. SITE SECURITY

The Texas A&M University Police Department or the HSC component's Director of Security is available to assist in evaluating and making recommendations regarding site security.

4.1 Specific locations (e.g., a laboratory or locked storage area assigned to the responsible party) should be established where controlled substances, controlled substance analogues, and chemical precursors are utilized and stored.

4.2 Access to rooms and locked storage areas containing controlled substances, controlled substance analogues, and chemical precursors must be restricted to authorized personnel.

4.3 Positions having access to controlled substances, controlled substance analogues, and chemical precursors should be designated as security sensitive and appropriate pre-employment criminal history checks must be performed.

5. OPERATIONAL SECURITY

5.1 Procedures must be established by each Responsible Party to assure the proper use of controlled substances in laboratories and storage areas.

5.2 Authorized personnel must be alert to any unauthorized personnel entering laboratories containing controlled substances and appropriate action must be taken to assure security when visitors are present.

5.3 The storage and handling of controlled substances must adhere to all applicable state and federal laws.

6. INVENTORY AND REPORTING OF LOSS

6.1 Prudent procedures must be established by each Responsible Party to monitor consumption and use of controlled substances to include a running balance of the amount in possession.

6.2 Authorized personnel must be alert and attentive to the disappearance of any controlled substances. Any losses must be reported to the appropriate Department Chair, Dean or Director (or designee), Vice President for Research, and Director of Security immediately (within the next business day) upon the discovery of the loss.

6.3 A full and complete inventory of all controlled substances must be completed at least once every 2 years.

7. DISPOSAL

Disposal of controlled substances must be accomplished in accordance with federal laws and state regulations and rules.

8. NOTIFICATION

The Vice President for Research will send a letter to all Deans, Directors, and Department Chairs reminding them of the elements of the controlled substance policy on an annual basis. The Department Chairs, Directors and PI's will be informed of their ultimate responsibility for adherence with this policy. Each HSC component will also be required to submit their controlled substance policy and their updated list of faculty and staff in possession of controlled substances to the Office of the Vice President for Research annually.

OFFICE OF RESPONSIBILITY

Office of the Vice President for Research and Graduate Studies