CHAPTER § 2.02 Regulation of Controlled Substances

• Jurisdiction: United States

§ 2.02 Regulation of Controlled Substances

[1] Applicable Laws

A variety of U.S. laws and international treaties frame U.S. regulatory requirements for controlled substances. Significant among these are the Single Convention on Narcotic Drugs and the Convention on Psychotropic Substances.¹ These treaties establish certain control principles, international coordination mechanisms, and oversight entities (e.g., the International Narcotics Control Board) that support global regulatory activities.

The primary U.S. statutes currently in effect are the Controlled Substances Act² and the Controlled Substances Import and Export Act³ (parts of a broader statute entitled the Comprehensive Drug Abuse Prevention and Control Act of 1970). Collectively, these statutes are commonly referred to as the Controlled Substances Act or "CSA."

In addition to federal law, a variety of state-level laws augment the complex regulatory regime for controlled substances.⁴

[2] Federal Regulatory Agencies

Regulatory authority over controlled substances is vested primarily in the Attorney General of the United States.⁵ The Attorney General has delegated this authority to the Administrator of the Drug Enforcement Administration ("DEA"), an agency within the U.S. Department of Justice.⁶ DEA has promulgated regulations, published guidance, and taken regulatory actions (e.g., inspections, enforcement proceedings) to implement legal requirements under the CSA.

The CSA assigns one important task to the Secretary of the U.S. Department of Health and Human Services ("HHS"): providing scientific and medical evaluations and recommendations regarding whether, and how, a drug or other substance should be controlled. The HHS recommendations are binding on DEA with respect to scientific and medical matters, and if HHS recommends that a drug or substance not be controlled, then DEA may not control it.⁷ The Secretary of HHS has delegated authority under the CSA to the Assistant Secretary for Health, who in turn relies on the Food and Drug Administration ("FDA") and other HHS Public Health Service agencies for data analysis and recommendations.⁸

In addition to responding to scheduling requests from DEA,⁹ FDA must apprise DEA if a new drug application is submitted for a product that has a stimulant, depressant, or hallucinogenic effect on the nervous system and appears to pose a potential for abuse. FDA elicits information about abuse liability as part of the new-drug review process.¹⁰

[3] Definition of "Controlled Substance"

The term "controlled substance" identifies a drug, other substance, or immediate precursor included in one of five categories—referred to as "schedules"—established by Congress and periodically updated by DEA.¹¹ A controlled substance can exist in various forms, including as an ingredient, in-process material, finished drug product, or waste (e.g., rejected matter or expired product).

As discussed in more detail later in this chapter, schedule classification determines the scope of security and other control measures that apply to a regulated firm or product. Requirements applicable to Schedule I and II products are often more stringent than corresponding requirements for Schedules III through V. This fact has commercial significance with respect to manufacturing and supply-chain options and costs. Schedule classification also can affect commercial promotion and the prescribing decisions of health care practitioners.

The classification of an item as a controlled substance must take into consideration: the product's actual or relative potential for abuse; available scientific evidence of pharmacological effect; the state of current scientific knowledge regarding the drug or other substance; its history and current pattern of abuse; the scope, duration, and significance of abuse; potential risk to the public health; the product's liability for psychic or physiological dependence; and whether the substance is an immediate precursor of a substance already controlled by law.¹² The definition of "controlled substance" expressly excludes distilled spirits, wine, malt beverages, and tobacco.¹³

The findings required for classification into the five federal regulatory "schedules" are set forth below:

Schedule I—A drug or other substance has a high potential for abuse, no currently accepted medical use in treatment in the United States, and there is a lack of accepted safety or use of the drug or other substance under medical supervision. Commonly recognizable examples include: 3,4-Methylenedioxymetham phetamine ("MDMA" or Ecstasy), heroin, marijuana (with limited exceptions for FDA-approved use of certain substances discussed below),¹⁴ tetrahydrocan-nabinols ("THC"),¹⁵ and gamma hydroxybutyric acid (GHB, with limited exception for FDA-approved use discussed below). Note:

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