Controlled Substances Used in Animal Research
(Tulane University)
Responsible University Officials: Director, Department of Comparative Medicine (DCM)
Director, Division of Veterinary Medicine (DVM)
Responsible Offices: Department of Comparative Medicine & Division of Veterinary Medicine
Coordinating Departments: Office of the Associate Senior Vice President for Research; Office of Research Compliance; Institutional Animal Care and Use Committee (“IACUC”).
Issued Date: October 23, 2009 Effective Date: July 1, 2010
Last Reviewed Date: October 23, 2009 Next Review Date: October 23, 2010
Who Needs to Know This Policy: Faculty Member, Students, and Staff participating in research using animals.
Website Address for This Policy: http://tulane.edu/asvpr/dcm/
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I. Background
Laws and regulations regarding controlled substances are documented in the federal Controlled Substances Act of 1970 and Louisiana Uniform Controlled Dangerous Substances Law (see Section II below for citations to regulatory authority). The intent of this policy is to minimize the chances of misuse that may occur when controlled drugs are used in animal or laboratory research. This policy applies to all Tulane University faculty, staff, and students and any other individuals using Tulane facilities that purchase controlled substances at Tulane in animal or laboratory research, testing, or teaching.
II. Regulatory Authority.
A. Federal: 21 CFR Part 1300-1308, Controlled Substance Act.
B. State: Louisiana Uniform Controlled Dangerous Substances Law, LA-R.S. Title 40, Chapter 4, Part X, Section 973, “Licensing Requirements”.
III. Policy and Procedure.
A. This policy addresses the acquisition, use, record keeping, and disposal of controlled substances (narcotic and non-narcotic) regulated by the Drug Enforcement Agency (“DEA”) and any other drugs designated by the DCM/DVM. This policy is endorsed by the Tulane University (“TU”) ASVPR. The goal of this policy is to ensure all TU employees and other individuals covered by this policy are in compliance with all state and federal regulations related to the legal purchase and use of controlled substances.
B. Required License Holders/Obtaining a License.
1. All Tulane faculty or staff or any other individuals using University resources or facilities that require the use of controlled substances in their research, teaching and testing activities that involve animals or laboratory work must be registered with the state of Louisiana and the DEA. The license can be held at the individual level or the unit level (e.g. department). Forms are available from the Louisiana Board of Pharmacy Controlled and Dangerous Substances located at https://www.labp.com. Federal DEA licenses may be obtained for research purposes at http://www.deadiversion.usdoj.gov/drugreg/index.html.
2. If use of controlled substances in animals is restricted to controlled substances that are dispensed directly to the animal by a member of the DCM/DVM staff (veterinarian, veterinary technician, or animal care), then registration is not required. For example, controlled substances that may fall into this category include anesthetics and analgesic agents that are administered to large animals (including nonhuman primates) by DCM/DVM staff for procedures conducted within DCM/DVM central surgery/animal housing areas.
3. In general, use of controlled substances for anesthetic/analgesic purposes in small animals such as rats and mice on which the investigator administers the agent to the animal will require that the investigator hold their own state and federal licenses. DCM/DVM staff will not dispense controlled substances to investigators.
4. When applying for a LA Board of Pharmacy license, applicants who do not fit within the categories of APRN, Dentist, Med. Psych, Optometrist, Physician, Physician Assistant, Podiatrist, or Veterinarian must submit a LA Controlled Dangerous Substances Protocol Form with the state license application. This form is available at
http://www.labp.com/cds/CDSProtocolForm.pdf.
C. The IACUC is responsible for the following items in regards to controlled substances:
1. Reviewing animal use protocols to ensure appropriate clinical applications for controlled substances are being used.
2. Monitoring the records of controlled substances used in animal research twice yearly during facility inspections.
D. The DCM/DVM is responsible for the following items in regards to controlled substances:
1. Providing information for DEA licensing to principal investigators (PIs) upon request.
2. Ensuring that PIs have current animal use protocols prior to initiating a study.
3. Acquiring and administering controlled substances directly to animals by DCM or DVM staff (veterinarians, veterinary technicians, and/or animal care technicians) for procedures conducted by the DCM/DVM.
E. In accordance with this policy, investigators and their staff purchasing controlled substances in animal research are responsible for the following:
1. Using controlled substances only under an approved and current animal use protocol that contains provisions for the use of controlled substances at appropriate dosing. Using controlled substances not included in the relevant IACUC-approved animal use protocols is prohibited.
2. Providing appropriate security (anchored cabinet with a minimum of 2 separately keyed doors and limited access to keys or lock combinations) for controlled substances.
3. Keeping records of controlled substance use on forms that are compatible with DEA requirements. A sample form is provided by DCM/DVM at http://tulane.edu/asvpr/dcm/.
4. Disposing of expired or unused controlled substances as per Section 29 “Hazardous Materials” of the Tulane University Environmental Health & Safety Policies and Procedures Manual located at http://www2.som.tulane.edu/oehs/safety/29hazmat.pdf. Contact OEHS at 504.988.5486 or 504.988.2865 for more information.
F. All controlled substance records are subject to inspection by the DCM/DVM, the IACUC, or other authorized review/compliance individuals without prior notice.
IV. Enforcement
A. Enforcement of these policies will be conducted by the DCM/DVM, IACUC, vivarium clients, and animal care users. Any person with concerns, complaints or wishing to report a violation regarding animal care and use at TU may do so by contacting the DCM at 504.988.5211, DVM at 985.871.6266, or the IACUC Chair at 504.988.6868.
B. The DEA is the principal Federal agency responsible for the enforcement of regulations involving controlled substances, and holders of controlled drug licenses will ultimately be responsible to that agency.
V. Related Forms
A. Controlled Drug Log
1
The official version of this information will only be maintained in an on-line web format. Any and all printed copies of this material are
dated as of the print date. Please make certain to review the material on-line prior to placing reliance on a dated printed version.