Drug Diversion - Registration of Drug Suppliers and Dispensers

Registration of Drug Suppliers and Dispensers

21 U.S.C. § 823 of the Controlled Substances Act provides for registration of manufacturers and distributors of controlled substances. The criteria for registering manufacturers of Schedule I and II drugs are particularly strict and call for "limiting the importation and bulk manufacture of such controlled substances to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical, scientific, research, and industrial purposes." The Attorney General must make a positive determination that the registration would be "consistent with the public interest."

For manufacturers of other drugs, and for drug distributors, the regulations are substantially less strict: "The Attorney General shall register an applicant… unless he determines that the issuance of such registration is inconsistent with the public interest." The criteria for both manufacture and distribution is somewhat biased in favor of established industries, favoring "past experience" and a record of compliance with drug laws .

The Controlled Substances Act also provides for the registration of medical practitioners (i.e., physicians, dentists, veterinarians, etc.), pharmacies and hospitals that prescribe, administer, or dispense controlled substances directly to patients, as well as individuals conducting approved research involving controlled substances. This category also includes narcotic treatment programs that administer and dispense primarily Methadone for narcotic addiction treatment.