21 - CONTROLLED SUBSTANCES FOR RESEARCH AND TEACHING

 

Section Contents

21.1 INTRODUCTION
21.2 PROCESS FOR OBTAINING CONTROLLED SUBSTANCES
21.3 AUTHORIZED PERSONNEL
21.4 SECURITY
21.5 RECORDKEEPING
21.6 DISPOSAL
21.7 THEFT OR LOSS
21.8 RESOURCES AND REFERENCES

 

21.1

INTRODUCTION

This procedure establishes the guidelines to follow for procuring controlled substances for research and teaching purposes. These guidelines are consistent with the District of Columbia regulations and the Code of Federal Regulations, 21 CFR 1300 through 1316. See also the Office of General Counsel web page on The Controlled Substance Act of 1970.

A controlled substance is defined as a drug or other substance, or its immediate precursor, as listed by the Drug Enforcement Administration in Schedules I, II, III, IV, or V. The definition does not include distilled spirits, wine, malt beverages, or tobacco.

Each principal investigator at The Catholic University of America who intends to perform research that will involve controlled substances must secure his or her own licenses from both the Drug Enforcement Agency (DEA) and the District of Columbia. The Principal Investigator must notify Environmental Health & Safety prior to submitting the application for a DEA license.

21.2

PROCESS FOR OBTAINING CONTROLLED SUBSTANCES
  1. Contact Environmental Health & Safety (EHS) at 202-319-4461 to review research/teaching protocol and procedures that require use of controlled substances. Schedule I and II substances require special handling.
  2. Apply for and obtain a District of Columbia Registration for Controlled Substances. Pick up an application at the Environmental Health Administration, Bureau of Food, Drug, and Radiation Protection, 51 N Street, NE, 6th Floor, Washington, DC, Monday through Friday, 8:30 a.m. to 4:30 p.m. Application fees and annual renewal fees apply.
  3. Apply for and obtain a federal Drug Enforcement Administration (DEA) Controlled Substance Registration Form 225 or 225A. Application fees and annual renewal fees apply.

21.3

AUTHORIZED PERSONNEL
  • Persons previously convicted of a felony offense relating to a controlled substance or who, at any time, had an application for registration with the DEA denied, had a DEA registration revoked, or surrendered a DEA registration for "cause" may not be authorized to work with controlled substances.
  • Only those persons registered with the DEA and with the District of Colombia to work with controlled substances may do so. As a license holder, a principal investigator possesses the authority and responsibility to delegate individuals in his or her laboratory to dispense controlled substances.

21.4

SECURITY
  • Store controlled substances in a locked cabinet with a solid door within an area that can be locked (total of at least two locks between user and the controlled substance. The number of keys to the locks should be kept to a minimum.
  • Security requirements vary by schedule, with schedule I and II drugs requiring that they be stored separately from III thru V. EHS can assist in determining whether or not the proposed storage area meets DEA requirements.
  • Schedule I and II drugs must be stored in an approved safe. Specifications for the safe are set forth in the regulations, and the Drug Enforcement Administration Field Office may also be called upon to review proposed security systems (21 CFR § 1301.72-76).

21.5

RECORDKEEPING
  • An initial inventory, and then annually thereafter, of all controlled substances must be documented on letterhead paper and recorded in a bound ledger book. This must be dated and signed by the person authorized to handle the controlled substances.
  • Utilization inventory: An actual count of the drug is recommended with each transaction. Include the date, balance, name of person dispensing the controlled substance, name of person receiving the controlled substance, justification for use, and amount added or distributed.
  • All records must be made in ink and maintained for at least two years.
  • The District of Columbia, the DEA, and EHS may perform unannounced audits and inspections at anytime.
  • EHS will perform on-site audits semi-annually in May and in November.

21.6

DISPOSAL
  • Contact the District of Columbia to arrange for disposal (202-535-2290). Obtain and complete an Inventory of Drugs Surrendered as necessary.
  • Any amount of controlled substance waste must be disposed of by the registered researcher and witnessed by either the District of Columbia or EHS.
  • Rinse the container with alcohol and dispose of the rinsate as hazardous waste.

21.7

THEFT OR LOSS
  • Contact Public Safety in cases of loss or theft (202-319-5111).
  • Contact the District of Columbia (202-535-2290) and EHS (202-319-4461).
  • Contact the DEA.
  • Complete appropriate paperwork within 72 hours of the theft or loss of drugs.

21.8

RESOURCES AND REFERENCES

CUA Office of Environmental Health & Safety
Phone: 202-319-5515
Fax: 202-319-4446

CUA Department of Public Safety
Phone: 202-319-5111 Fax: 202-319-5110

DC Department of Health
Health Regulation & Licensing Administration
Pharmaceutical Control Division
717 14th Street NW, 6th Floor
Washington, DC 20005
Phone: 202-724-4900

US Department of Justice, Washington Division
Phone: 202-305-8500