Criteria For Controlling And Scheduling Drugs

Several factors are considered before a drug is controlled under this act. These factors include the potential for abuse (i.e., history, magnitude, dura tion, and significance), risk to public health, and potential of physical or psychological dependence. Drugs controlled under this act are divided into five Schedules (I—V) according to their potential for abuse, ability to produce dependence, and medical utility. Drugs in Schedule I have a high potential for abuse and/or dependence with no accepted medical use or they lack demonstrated clinical safety. Those in Schedules II—V may have a high potential for abuse or ability to produce dependence but also have an accepted medical use. (However, some substances which have no accepted medical use but which are precursors to clinically useful substances may also be found in Schedules II—V. For example, thebaine, found naturally in OPIUM, has no medical use but it is a substance used in the manufacture of CODEINE and a series of potent OPIOID compounds as well as opioid ANTAGONISTS.) The potential for abuse and the ability to produce dependence is considered to be the greatest for Schedule I and II drugs and progressively less for Schedule III, IV, and V (see Table 1).

The amount of controlled drug in a product can also determine the schedule in which it is placed. For example, AMPHETAMINE, METHAMPHETAMINE, and codeine, as pure substances, are placed in Schedule II; however, these same drugs in limited quantities and in combination with a noncontrolled drug are placed in Schedules III and V. Drugs in Schedule V generally contain limited quantities of certain narcotic drugs used for cough and antidiarrheal purposes and can only be distributed or dispensed for medical purposes.

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