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Research Responsibilities and Compliance

Controlled Substances

Controlled Substances Program

Controlled substances are drugs that are regulated by the Drug Enforcement Administration (DEA) and the State of Ohio Board of Pharmacy because of potential for abuse. Federal and state guidelines govern the responsible conduct of research associated with the use of controlled substances. Failure to meet DEA and Board of Pharmacy registration and licensing requirements specific to the use of controlled substances in animal and laboratory research may result in regulatory sanctions, fines, and/or drug diversion of controlled substances from their lawful purpose into illicit drug traffic. DEA regulations and Board of Pharmacy rules allow faculty and staff researchers to obtain and use controlled substances in IACUC-approved animal research or Institutional Biosafety Committee (IBC)-approved research with cell culture systems or other in vitro analyses (“laboratory research”). To do so, investigators must either:

  • hold a current individual DEA research or instructing registration and a State of Ohio Board of Pharmacy Terminal (TDDD) Distributor License or
  • conduct their research as an authorized agent of a university official or investigator who holds a current DEA registration and Board of Pharmacy TDDD License.

NOTE: The policy does not apply to controlled substances used in Institutional Review Board (IRB)-approved research involving the use of human subjects by university faculty and staff who are licensed healthcare practitioners in the State of Ohio and hold current DEA registrations. Further, the policy does not apply to controlled substances used in Institutional Animal Care and Use Committee (IACUC)-approved veterinary clinical trials by university faculty and professional staff members who are licensed veterinarians in the State of Ohio and hold a DEA controlled substance registration for veterinary use.

Researcher Roles and Responsibilities

Register

Investigators who seek to obtain a research or instructing registration for use of controlled substances in animal or laboratory research must first notify their college and/or department prior to registering with the Board of Pharmacy and/or the DEA.

Registration Holders and Authorized Agent Programs

Those whose role will require them to become an authorized agent will need to be listed as an authorized agent on Ohio State Controlled Substance Form 3 – Authorized Agent List, complete a Security Release using Ohio State Controlled Substance Form 4- Security Release, and undergo a background check.

Any laboratory staff who do not come into contact with or have direct access to the controlled substances themselves (e.g., they work on other experiments, they perform custodial duties in the laboratory, etc.) should not become authorized agents.

Purchase

You may purchase controlled substances from internal university sources or from outside distributors like Sigma-Aldrich; Butler Schein, Inc.; Fort Dodge Laboratories; etc. Contact your purchasing department or your college/department registration holder or their program administrator for more information.

Training

All registrants and authorized agents must undergo appropriate training on the use of controlled substances in research in order to meet the regulatory requirements. The college and/or department of the registrant under whom the research is being conducted provides this training. A required, but not exhaustive, list of training elements includes: regulatory overview, controlled substance schedules, recordkeeping requirements and form use, storage, disposal, personnel changes, and best practices. If you are serving as an authorized agent, contact the registration holder or responsible program administrator for your college/department/unit. When necessary, training can be provided by another college/department (with its permission).

Storage

Registrants and authorized agents may only receive and store the minimum amount of controlled substances needed for current research. All controlled substances must be stored in a locked steel cabinet or a locked substantially constructed cabinet. Controlled substances should not be located near a glass panel where they can be visible from the outside.

Disposal

Damaged, expired, unwanted, unusable, or non-returnable controlled substances must be accounted for, stored, and disposed of in accordance with applicable state and federal regulations. Disposal of a controlled substance must render it non-retrievable. Though the DEA does not specify destruction methods, it does state, “the process utilized to render a substance ‘non-retrievable’ shall permanently alter the substance’s physical or chemical condition or state through irreversible means and thereby render the substance unavailable and unusable for all practical purposes. A substance is considered ‘non-retrievable’ when it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue.”

Disposal Methods

The Registrant Record of Controlled Substances Destroyed form (DEA Form 41) must be completed prior to disposing of any controlled substance. A copy of the completed form must be retained by the registrant or the authorized agent for at least five (5) years.

Commercially available active-charcoal chemical digestion systems like Rx Destroyer™️ or DRUGBUSTER® can be purchased for the use of on-site disposal to render a controlled substance non-retrievable. Alternatively, controlled substances can be rendered non-retrievable by mixing them into latex paint and allowing the paint to solidify. Once dry, the latex paint plug can be disposed of in the regular trash. If this method is employed, the paint mixture must be securely maintained (e.g., supervised and/or locked in the lab’s controlled substance storage cabinet) until completely dry.

Disposal methods that do not permanently alter the substance’s physical or chemical state or render the controlled substance non-retrievable (e.g., flushing, rinsing down the drain, or mixing the controlled substance with an undesirable substance like coffee grounds or kitty litter) are no longer sufficient in meeting the DEA’s “non-retrievable” standard.

If additional information is needed, consult the Controlled Substances policy (section VIII), contact the program administrator for your college, or contact our office at controlledsubstances@osu.edu or 614-292-5714.

Exempt Chemical Preparations

Without a DEA registration, investigators may lawfully purchase, use in research, and store only those controlled substances in the forms described on the DEA exempt chemical preparation list. Use of exempt chemical preparations is intended for laboratory, industrial, or educational purposes and not for immediate or subsequent administration to a human being or other animal.

Additional Information

ORC
Associate Director, Research Integrity Officer

Courtney Mankowski - Office of Research Compliance

6142925714