FEDERAL LAWS CONCERNING DRUGS

LEARNING OBJECTIVES: Explain the formal scheduling of drugs. List four items that determine a drug's potential for abuse, and identify eight factors that determine the schedule into which a drug should be placed. Identify the characteristics of each of the five schedules of drugs. Explain temporary drug scheduling, controlled substance analogues, and international drug treaty obligations.

The Federal Controlled Substances Act (FCSA), Title II, of the Comprehensive Drug Abuse Prevention and Control Act of 1970, is the legal foundation of the government's fight against abuse of drugs and other substances. This law is a consolidation of numerous laws regulating the manufacture and distribution of narcotics, stimulants, depressants, and hallucinogens. Drugs may placed on the on the FCSA by administrative or legislative acts passed by Congress. More recently, in 1988, congress passed the Chemical Diversion and Trafficking Act. This Act allows for the regulation of certain chemicals that are used in the making of controlled substances.

FORMAL SCHEDULING

The FCSA places all substances that are 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, or added to a schedule; decontrolled, or removed from control; and rescheduled or transferred from one schedule to another. The procedure for these actions is found in Section 201 of the FCSA (21 U.S.C. 811).

Proceedings to add, delete, or change the schedule of a drug or other substance may be initiated by the Department of Health and Human Services (HHS), by the DEA, or by petition from any interested person- 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, or an individual citizen. When a petition is received by the DEA, the agency begins its own investigation of the drug.

The agency also may begin an investigation 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 administrator of the DEA, 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 of Health of HHS. HHS solicits information from the Commissioner of FDA, evaluations and recommendations from the National Institute on Drug Abuse, and, on occasion, from the scientific and medical community at large. 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. The recommendation on scheduling is binding only to the extent that if HHS recommends that the substance not be controlled, the DEA may not control the substance.

The threshold issue is whether the drug or other substance has potential for abuse. 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 FCSA, 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: 

. There is evidence that individuals are taking the drug or drugs containing such a substance in amounts sufficient to create a hazard to their health or to the safety of other individuals or of the community.

. There is significant diversion of the drug or drugs containing such a substance from legitimate drug channels. 

. Individuals are taking the drug or drugs containing such a substance on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such drugs in the course of his or her professional practice.

. The drug or drugs containing such a substance are new drugs so related in their action to a drug or drugs already listed as having a potential for abuse to make it likely that the drug will have the same potentiality for abuse as such drugs, thus making it reasonable to assume that there may be significant diversions from legitimate channels, 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 should be considered. Specific findings are not required for each factor. These factors are listed in Section 201 (c), 21 U.S.C. 811 (c), of the FCSA and are as follows:

(1) The drug's actual or relative potential for abuse.

(2) Scientific evidence of the drug's pharmacological effects. The state of knowledge with respect to the effects of a specific drug is, of course, a major consideration. It is vital to know, for example, whether or not a drug has a hallucinogenic effect if it is to be controlled because of that. 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, including the socioeconomic characteristics of the segments of the population involved in such abuse.

(5) The scope, duration, and significance of abuse. In evaluating existing abuse, the administrator must know not only the pattern of abuse but whether the abuse is widespread. In reaching his or her decision, the administrator should consider the economics of regulation and enforcement attendant to such a decision. In addition, he or she should be aware of the social significance and impact of such a decision upon those people, especially the young, that would be affected by it.

(6) What risk, if any, 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 physically addictive or psychologically habit-forming, if such information is known.

(8) Whether the substance is an immediate precursor of a substance already controlled. The FCSA allows inclusion of immediate precursors on this basis alone into the appropriate schedule and thus safeguards against possibilities of clandestine manufacture.

After considering the previous 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 established by the FCSA. They are as follows.

Schedule I 

l 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. 

l There is a lack of accepted safety for use of the drug or other substance under medical supervision.

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

l 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.

Schedule III

. The drug or other substance has a potential for abuse less 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.

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.

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.

When the administrator of the DEA has determined that a drug or other substance should be controlled, decontrolled, or rescheduled, a proposal will be published in the Federal Register setting forth the schedule for which control is proposed, or that a substance should be decontrolled, and inviting all interested persons to file comments with the DEA. Affected parties may also request a hearing with the DEA. If no hearing is requested, the DEA will evaluate all comments 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 imposed under the FCSA.

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 administrator of the DEA. The administrator will review these documents, as well as the underlying material, and prepare his or 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 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, interested 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.