Ohio Administrative Code › Title 3364 - University of Toledo › Chapter 3364-70 - Research Protection and Practices › Section 3364-70-27 - The use of controlled substances and dangerous drugs in animal and in-vitro research

Current through all regulations passed and filed through July 1, 2024
(A)
								Policy
			 statement
The United States drug enforcement
				administration ("DEA") and the state of Ohio board of pharmacy regulate the use
				of controlled substances and dangerous drugs. The university of Toledo
				("UToledo") and its employees will comply with the federal and state laws and
				regulations that pertain but are not limited to ordering, storing, dispensing,
				recording and destruction of controlled substances and dangerous drugs used in
				animal and in-vitro research.
To obtain, synthesize, and use
				controlled substances in UToledo institutional animal care and use committee
				("IACUC") approved animal or in-vitro research, an investigator must be either
				a registrant or authorized agent.
(B)
								Purpose of
			 policy
The purpose of this policy is to
				facilitate a general understanding of the steps necessary to comply with
				federal and state laws and regulations governing controlled substances and
				dangerous drugs in UToledo animal or in-vitro research and to ensure safe
				handling and security of controlled substances and dangerous
				drugs.
(C)
								Scope
This policy applies to all UToledo
				faculty, students and staff using controlled substances or dangerous drugs in
				animal and in-vitro research.
(D)
								Definitions
(1)
									"Registrant":
			 UToledo employee who holds both a current DEA registration and a state of Ohio
			 board of pharmacy terminal distributor of dangerous drugs ("TDDD")
			 license.
(2)
									"Authorized agent": UToledo employee or student who is
			 authorized to act on behalf of or at the direction of the registrant with
			 respect to controlled drug access, use, receipt, and disposal.
(3)
									"Controlled
			 substances": drugs regulated by U.S. government including illegal and
			 prescription drugs. List of controlled substances found online at
			 https://www.deadiversion.usdoj.gov/schedules/orangebook/a_sched.alpha.pdf.
(4)
									"Controlled
			 substance schedules": classification of controlled substances used by the DEA.
			 An updated list of schedules may be found online at
			 https://www.deadiversion.usdoj.gov/schedules/.
(5)
									"Dangerous
			 drugs": as defined by section
			 4729.01 of the Revised Code; any
			 drug with a label prohibiting dispensing or use without a prescription or by
			 order of a licensed veterinarian, and drugs that may be dispensed only upon a
			 prescription; any drug intended for administration by injection into the human
			 body other than through a natural orifice of the human body. These are also
			 known as "pharmaceutical grade" drugs. This does not include substances known
			 as "chemical grade" or "reagent grade."
(6)
									"DEA": U.S. drug
			 enforcement administration, the U.S. department of justice law enforcement
			 agency.
https://www.deadiversion.usdoj.gov/
(7)
									"IACUC" The
			 UToledo IACUC or an IACUC authorized in writing by the UToledo office of
			 research and sponsored rograms ("RSP").
(8)
									"List I and list
			 II chemicals": chemicals specifically designated by the DEA and used in
			 manufacturing a controlled substance.