DRCNet Response to the
Drug Enforcement Administration
The dispensing of a controlled substance is the delivery of the controlled substance to the ultimate user, who may be a patient or research subject. Special control mechanisms operate here as well. Schedule I drugs are those which have no currently accepted medical use in the United States; they may, therefore, be used in the United States only in research situations. They generally are supplied by only a limited number of firms to properly registered and qualified researchers. Controlled substances may be dispersed by a practitioner by direct administration, by prescription, or by dispensing from office supplies. Records must be maintained by the practitioner of all dispensing of controlled substances from office supplies and of certain administrations. The CSA does not require the practitioner to maintain copies of prescriptions, but certain states require the use of multiple copy prescriptions for Schedule II and other specified controlled substances.
The determination to place drugs on prescription is within the jurisdiction of the FDA. Unlike other prescription drugs, however, controlled substances are subject to additional restrictions. Schedule II prescription orders must be written and signed by the practitioner; they may not be telephoned into the pharmacy except in an emergency. In addition, a prescription for a Schedule II drug may not be refilled; the patient must see the practitioner again in order to obtain more drugs. For Schedule III and IV drugs, the prescription order may be either written or oral (that is, by telephone to the pharmacy). In addition, the patient may (if authorized by the practitioner) have the prescription refilled up to five times and at anytime within six months from the date of the initial dispensing.
Schedule V includes some prescription drugs and many over-the-counter narcotic preparations, including antitussives and antidiarrheals. Even here, however, the law imposes restrictions beyond those normally required for the over-the-counter sales; for example, the patient must be at least 18 years of age, must offer some form of identification, and have his or her name entered into aspecial log maintained by the pharmacist as part of a special record.
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