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The Controlled Substances Act of 1970 (CSA) established a classification structure for certain drugs and chemicals used in drug manufacturing. The CSA was enacted to coordinate a national approach toward the growing problem of drug abuse and drug control. The Drug and Enforcement Agency (DEA) and the Food and Drug Agency are responsible for maintaining the listing of controlled substances. 21 U.S.C. §§ 801 and 812. Controlled substances are classified into five schedules on the basis of their currently accepted medical use and potential for abuse and dependence. Id. at 822.
The CSA mandates that the DEA establish a closed system of control for manufacturing, distributing, and dispensing controlled substances. Any person who manufactures, dispenses, imports, exports, or conducts research with controlled substances must register with DEA (unless exempt), keep track of all stocks of controlled substances, and maintain records to account for all controlled substances received, distributed, or otherwise disposed of. Although all registrants, including pharmacies, are required to maintain records of controlled substance transactions, only manufacturers and distributors are required to report their Schedule I and II drugs and Schedule III narcotics drug transactions, including sales to the retail level, to DEA. The data provided to DEA are available for use in investigations of illegal diversions. The act does not require pharmacies to report dispensing information at the patient level to DEA.
Each provider must obtain a valid registration from DEA that reflects the schedule(s) of controlled substances the provider is authorized to store, dispense, administer, or prescribe. For example, if a physician wants the authority to prescribe Schedule II drugs, the physician must register and be granted authority by DEA to do so.
Common Areas of Concern.
The AHLA thanks Michael L. Silhol for the initial content of this article.