21 U.S.C. § 814 — Removal of exemption of certain drugs

(a) Removal. By regulation, the Attorney General must remove from the exemption in section 802(39)(A)(iv) a drug or group of drugs that the Attorney General finds is being diverted to obtain a listed chemical for illicit production of a controlled substance. (b) Factors. The Attorney General must consider the diversion's scope, duration, and importance; whether the drug is made so it cannot easily be used for illicit production; and whether the listed chemical can readily be recovered from it. (c) Specificity. The designation must be limited to the most specifically identifiable drug or group for which diversion evidence exists, unless the diversion pattern and other relevant factors show that diversion will not be limited to that drug or group. (d) Restoration for particular products. (1) On a manufacturer's application, the Attorney General must restore the exemption for a particular product removed under subsection (a) if the product is made and distributed in a way that prevents diversion. (2) The Attorney General must consider package size and packaging; distribution and advertising; evidence of diversion; the manufacturer's prevention steps; and other factors relevant to and consistent with public health and safety, including the factors in subsection (b) as applied to the product. (3) A transaction involving a product with a genuine pending restoration application filed within 60 days after the removal regulation is issued is not a regulated transaction while the application is pending and, if denied, for 60 days after denial, unless the Attorney General has evidence the product is being diverted under the subsection (b) factors and notifies the applicant. (4) A restoration regulation may be changed or revoked if those factors show diversion or if the data supporting the regulation has significantly changed.