Ohio Administrative Code › Title 3341 - Bowling Green State University › Chapter 3341-7 - Research › Section 3341-7-09 - Use of controlled substances in research

Current through all
			 regulations passed and filed through July 1, 2024
(A)
								Policy statement
			 and purpose
Controlled substances are drugs which
				are regulated by the DEA and the Ohio state board of pharmacy because of
				potential for abuse. This policy describes the responsibilities of the
				investigators who use controlled substances in research and the investigators'
				responsibilities to comply with state of Ohio and DEA requirements concerning
				the administration, handling, storage, destruction and/or transfer of
				controlled substances.
(B)
								Policy
(1)
									Policy
			 scope
While controlled substances are
				infrequently purchased by BGSU for research purposes, there are several units
				on the BGSU campus that hold DEA licenses. This policy has been created to
				ensure that BGSU and its investigators are in compliance with the federal and
				state laws governing controlled substances, thus minimizing risk to the
				university.
Controlled substances are designated by
				the DEA as schedule I - V according to their medical use, potential for abuse,
				and safety or dependence liability. Each controlled substance, or basic class
				thereof, has been assigned an "Administration Controlled Substances Code
				Number" for purposes of identification of the substances or class on certain
				certificates of registration issued by the administration pursuant to
				21 CFR
				1301.35 and on certain order forms issued by
				the administration pursuant to
				21 CFR
				1305.05.
(a)
										Schedule of
			 controlled substances ( 21 CFR 1308 )
Schedule I substances have a high
				potential for abuse and no accepted medical use in treatment in the United
				States. Examples of schedule I substances include heroin, lysergic acid
				diethylamide (LSD), and methaqualone.
Schedule II substances have currently
				accepted medical use in treatment in the United States; however, they have
				severe restrictions, due to their high potential for abuse, which may lead to
				severe psychological or physical dependence. Examples of schedule II substances
				include pentobarbital, morphine, cocaine, and methadone.
Schedule III substances have currently
				accepted medical use in treatment in the United States and less potential for
				abuse the substances listed in schedule I and II. Abuse may lead to moderate or
				low physical dependence or high psychological dependence. Ketamine, codeine and
				hydrocodone are examples of schedule III substances.
Schedule IV substances have accepted
				medical use in clinical treatment and a lower potential for abuse relative to
				substances in schedule III. Abuse of Schedule IV substance, however, may lead
				to limited physical dependence or psychological dependence. Examples of drugs
				included in schedule IV are midazolam, lorazempam, and
				phenobarbital.
Schedule V substances have currently
				accepted medical uses with low potential for abuse. Cough medicines with
				codeine are examples of schedule V drugs.
(b)
										Corrective
			 measures
Failure of investigators and authorized
				individuals to follow the requirements of this policy may result in personal
				civil and criminal liability under state and federal law and termination of
				university employment. In addition, failure may result in university
				disciplinary action under applicable faculty and staff policies.