CONTROLLING DRUGS OR OTHER SUBSTANCES THROUGH FORMAL SCHEDULING

The Controlled Substances Act (CSA) places all substances which were in some manner regulated under existing federal law into one of five schedules. This placement is based upon the substance’s medical use, potential for abuse, and safety or dependence liability. The Act also provides a mechanism for substances to be controlled (added to or transferred between schedules) or decontrolled (removed from control). The procedure for these actions is found in Section 201 of the Act (21U.S.C. §811).

Proceedings to add, delete, or change the schedule of a drug or other substance may be initiated by the Drug Enforcement Administration (DEA), the Department of Health and Human Services (HHS), or by petition from any interested party, including:

»» The manufacturer of a drug

»» A medical society or association

»» A pharmacy association

»» A public interest group concerned with drug abuse

»» A state or local government agency

»» An individual citizen

When a petition is received by the DEA, the agency begins its own investigation of the drug. The DEA also may begin an investiga tion of a drug at any time based upon information received from law enforcement laboratories, state and local law enforcement and regulatory agencies, or other sources of information.

Once the DEA has collected the necessary data, the DEA Administrator, by authority of the Attorney General,

requests from HHS a scientific and medical evaluation and recommendation as to whether the drug or other substance should be controlled or removed from control. This request is sent to the Assistant Secretary for Health of HHS.

The Assistant Secretary, by authority of the Secretary, compiles the information and transmits back to the DEA: a medical and scientific evaluation regarding the drug or other substance, a recommendation as to whether the drug should be controlled, and in what schedule it should be  placed.

The medical and scientific evaluations are binding on the DEA with respect to scientific and medical matters and form a part of the scheduling  decision.

Once the DEA has received the scientific and medical evalu- ation from HHS, the Administrator will evaluate all available data and make a final decision whether to propose that a drug or other substance should be removed or controlled and into which schedule it should be  placed.

If a drug does not have a potential for abuse, it cannot be controlled. Although the term “potential for abuse” is not defined in the CSA, there is much discussion of the term in the legislative history of the Act. The following items are indicators that a drug or other substance has a potential for  abuse:

1. There is evidence that individuals are taking the drug or other substance in amounts sufficient to create a hazard to their health or to the safety of other individuals or to the community.
2. There is significant diversion of the drug or other sub- stance from legitimate drug channels.
3. Individuals are taking the drug or other substance on their own initiative rather than on the basis of medical advice from a practitioner.
4. The drug is a new drug so related in its action to a drug or other substance already listed as having a potential for abuse to make it likely that the drug will have the same potential for abuse as such drugs, thus making it reasonable to assume   that there may be significant diversions from legitimate chan- nels, significant use contrary to or without medical advice, or that it has a substantial capability of creating hazards to the health of the user or to the safety of the community. Of course, evidence of actual abuse of a substance is indicative that a drug has a potential for abuse.

In determining into which schedule a drug or other substance should be placed, or whether a substance should be decontrolled or rescheduled, certain factors are required to be considered.

These factors are listed in Section 201 (c), [21 U.S.C. § 811 (c)] of the CSA   as follows:

1. The drug’s actual or relative potential for abuse.
2. Scientific evidence of the drug’s pharmacological effect, if known. The state of knowledge with respect to the effects of a specific drug is, of course, a major consideration. For example, it is vital to know whether or not a drug has a hallucinogenic effect if it is to be controlled due to that effect.The best available knowledge of the pharmacological properties of a drug should be  considered.
3. The state of current scientific knowledge regarding the substance. Criteria (2) and (3) are closely related. However, (2) is primarily concerned with pharmacological effects and (3) deals with all scientific knowledge with respect to the substance.
4. Its history and current pattern of abuse. To determine whether or not a drug should be controlled, it is important to know the pattern of abuse of that substance.
5. The scope, duration, and significance of abuse. In evaluating existing abuse, the DEA Administrator must know not only the pattern of abuse, but whether the abuse is widespread.
6. What, if any, risk there is to the public health. If a drug creates dangers to the public health, in addition to or because of its abuse potential, then these dangers must also be considered by the Administrator.
7. The drug’s psychic or physiological dependence liability. There must be an assessment of the extent to which a drug is physi- cally addictive or psychologically habit  forming.
8. Whether the substance is an immediate precursor of a substance already controlled. The CSA allows inclusion of immediate precursors on this basis alone into the appropriate schedule and thus safeguards against possibilities of clandestine manufacture. After considering the above listed factors, the Administrator  must make specific findings concerning the drug or other substance. This will determine into which schedule the drug or other substance will be placed. These schedules are establishedby the CSA. They are as follows:

Schedule I

»» The drug or other substance has a high potential for abuse.

»» The drug or other substance has no currently accepted medical use in treatment in the United  States.

»» There is a lack of accepted safety for use of the drug or other

substance  under  medical supervision.

»» Examples of Schedule I substances include heroin, gamma hydroxybutyric acid (GHB), lysergic acid diethylamide (LSD), marijuana,  and  methaqualone.

Schedule II

»» The drug or other substance has a high potential for abuse.

»» The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions.

»» Abuse of the drug or other substance may lead to severe psychological or physical  dependence.

»» Examples of Schedule II substances include morphine, phencyclidine (PCP), cocaine, methadone, hydrocodone, fentanyl, and methamphetamine.

Schedule III

»» The drug or other substance has less potential for abuse than the drugs or other substances in Schedules I and II.

»»  The drug or other substance has a currently accepted medical use in treatment in the United States.

»» Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological  dependence.

»» Anabolic steroids, codeine and hydrocodone products with aspirin or Tylenol®, and some barbiturates are examples of Schedule III substances.

Schedule IV

»» The drug or other substance has a low potential for abuse relative to the drugs or other substances in Schedule   III.

»» The drug or other substance has a currently accepted medical use in treatment in the United States.

»» Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in Schedule III.

»» Examples of drugs included in Schedule IV are  alprazolam, clonazepam, and diazepam.

Schedule V

»» The drug or other substance has a low potential for abuse relative to the drugs or other substances in Schedule   IV.

»» The drug or other substance has a currently accepted medical use in treatment in the United States.

»» Abuse of the drug or other substances may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in Schedule   IV.

»» Cough medicines with codeine are examples of Schedule V drugs.

When the DEA Administrator has determined that a drug or other substance should be controlled, decontrolled,  or rescheduled, a proposal to take action is published in the Federal Register. The proposal invites all interested persons to file comments with the DEA and may also request a hearing with the DEA. If no hearing is requested, the DEA will evaluate all com- ments received and publish a final order in the Federal Register, controlling the drug as proposed or with modifications based upon the written comments filed. This order will set the effective dates for imposing the various requirements of the   CSA.

If a hearing is requested, the DEA will enter into discussions  with the party or parties requesting a hearing in an attempt to narrow the issue for litigation. If necessary, a hearing will then be held before an Administrative Law Judge. The judge will   take evidence on factual issues and hear arguments on legal questions regarding the control of the drug. Depending on the scope and complexity of the issues, the hearing may be brief or quite extensive. The Administrative Law Judge, at the close of the hearing, prepares findings of fact and conclusions of law and a recommended decision that is submitted to the DEA Administra- tor. The DEA Administrator will review these documents, as well  as the underlying material, and prepare his/her own findings of fact and conclusions of law (which may or may not be the same   as those drafted by the Administrative Law Judge). The DEA Administrator then publishes a final order in the Federal Register either scheduling the drug or other substance or declining to do so.

Once the final order is published in the Federal Register, inter- ested parties have 30 days to appeal to a U.S. Court of Appeals to challenge the order. Findings of fact by the Administrator  are deemed conclusive if supported by “substantial evidence.” The order imposing controls is not stayed during the appeal, however, unless so ordered by the Court

Emergency or Temporary Scheduling

The CSA was amended by the Comprehensive Crime Control Act of 1984.ThisActincludedaprovisionwhichallowstheDEAAdministra- tor to place a substance, on a temporary basis, into Schedule I, when necessary, to avoid an imminent hazard to the public safety.

This emergency scheduling authority permits the scheduling of  a substance which is not currently controlled, is being abused, and is a risk to the public health while the formal rulemaking procedures described in the CSA are being conducted. This emergency scheduling applies only to substances with no accepted medical use.

A temporary scheduling order may be issued for one year with a possible extension of up to six months if formal scheduling procedures have been initiated. The notice of intent and order are published in the Federal Register, as are the proposals and orders for formal scheduling. [21 U.S.C. § 811 (h)]

Controlled  Substance analogues

A new class of substances was created by the Anti-Drug Abuse Act of 1986. Controlled substance analogues are substances that are not controlled substances, but may be found in illicit trafficking. They are structurally or pharmacologically similar to Schedule I or II controlled substances and have no legitimate medical use. A substance that meets the definition of a  controlled substance analogue and is intended for human consumption is treated under the CSA as if it were a controlled substance in Schedule I. [21 U.S.C. § 802(32), 21 U.S.C. § 813]

International treaty obligations

United States treaty obligations may require that a drug or other substance be controlled under the CSA, or rescheduled if existing controls are less stringent than those required by a treaty. The procedures for these scheduling actions are found in Section 201 (d)of the Act. [21 U.S.C. § 811 (d)]

The United States is a party to the Single Convention on Narcotic Drugs of 1961, which was designed to establish effective control over international and domestic traffic in narcotics, coca leaf, cocaine, and cannabis. A second treaty, the Convention on Psychotropic Substances of 1971, which entered into force in 1976 and was ratified by Congress in 1980, is designed to establish comparable control over stimulants, depressants, and hallucinogens.

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