from the market.192 One must register with the Drug Enforcement Agency
(DEA) to prescribe or dispense a scheduled drug.193 All scheduled drugs
require the prescriber and dispenser to keep accurate and detailed records of
their transactions.194 In addition, Schedule I and II drug prescriptions
require each order to be placed on a triplicate, with one copy forwarded to
the DEA.195 The CSA also provides disincentives to physicians for drug
over-prescription in the form of penalties, ranging from a $100,000–
250,000 fine to up to one year in prison for first-time offenders.196
The CSA can theoretically incorporate antibiotics as a Schedule V
controlled substance.197 The Department of Health and Human Services
(HHS) Secretary and the Attorney General (AG) (or the DEA with the
AG’s delegated authority) share drug-scheduling authority.198 When
scheduling a drug, the HHS makes medical judgments199 and scientific
determinations about a specific drug product, and the AG promulgates the
rules relating to the registration and control of the “efficient execution of his
functions.”200 Eight factors are considered in determining whether the
scheduling should be authorized: ( 1) the actual or potential abuse of the
drug; ( 2) the scientific evidence of its pharmacological effect; ( 3) the state
of current scientific knowledge; ( 4) the history and current pattern of abuse
of the drug; ( 5) the scope, duration, and significance of the abuse; ( 6) the
risks to the public health; ( 7) the psychic or physiological dependence
liability; and ( 8) whether the substance is an immediate precursor of a
substance already controlled under this subchapter.201
The CSA establishes three elements for Schedule V drugs: ( 1) the
drug has a low potential for abuse relative to the drugs or other substances
in schedule IV; ( 2) the drug has a currently accepted medical use in
treatment in the United States; and ( 3) abuse of the drug may lead to limited
192. 21 U.S. C. § 812 (2012).
193. NIELSEN, supra note 128, at 67.
194. BRIAN T. YEH, CONG. RESEARCH SERV., RL34635, THE CONTROLLED SUBSTANCES
ACT: REGULATORY REQUIREMENTS 2 (2012).
195. Id. at 97.
196. BRIAN T. YEH, CONG. RESEARCH SERV., RL30722, DRUG OFFENSES: MAXIMUM
FINES AND TERMS OF IMPRISONMENT FOR VIOLATIONS OF THE FEDERAL CONTROLLED
SUBSTANCES ACT AND RELATED LAWS 6 (2015).
197. Scott B. Markow, Penetrating the Walls of Drug-Resistant Bacteria: A Statutory
Prescription to Combat Antibiotic Misuse, 87 GEO. L.J. 531, 542 (1998) (“The Attorney
General may be able to schedule antibiotics based on potential for abuse by prescribers and
the risk that they pose to the public health.”).
198. Gonzales v. Oregon, 546 U.S. 243, 265 (2006).
199. Id. at 265.
200. Id. at 259.
201. 21 U.S. C. § 811(c)( 1)( 7) (2015).