21 U.S.C. § 821 — Rules and regulations

Page 805 TITLE 21—FOOD AND DRUGS § 822 (D) any actions taken by the manufacturer to prevent diversion of the drug product; and (E) such other factors as are relevant to and consistent with the public health and safety, including the factors described in subsection (b) as applied to the drug prod- uct. (3) Status pending application for reinstate- ment A transaction involving a particular drug product that is the subject of a bona fide pend- ing application for reinstatement of exemp- tion filed with the Attorney General not later than 60 days after a regulation removing the exemption is issued pursuant to subsection (a) shall not be considered to be a regulated transaction if the transaction occurs during the pendency of the application and, if the At- torney General denies the application, during the period of 60 days following the date on which the Attorney General denies the appli- cation, unless— (A) the Attorney General has evidence that, applying the factors described in sub- section (b) to the drug product, the drug product is being diverted; and (B) the Attorney General so notifies the applicant. (4) Amendment and modification A regulation reinstating an exemption under paragraph (1) may be modified or revoked with respect to a particular drug product upon a finding that— (A) applying the factors described in sub- section (b) to the drug product, the drug product is being diverted; or (B) there is a significant change in the data that led to the issuance of the regula- tion. (Pub. L. 91–513, title II, § 204, as added Pub. L. 103–200, § 2(b)(1), Dec. 17, 1993, 107 Stat. 2334; amended Pub. L. 104–237, title IV, § 401(c), Oct. 3, 1996, 110 Stat. 3108; Pub. L. 109–177, title VII, § 712(a)(2), Mar. 9, 2006, 120 Stat. 263.) Editorial Notes AMENDMENTS 2006—Subsec. (e). Pub. L. 109–177 struck out subsec. (e). Text read as follows: ‘‘Pursuant to subsection (d)(1) of this section, the Attorney General shall by regula- tion reinstate the exemption with respect to a par- ticular ephedrine, pseudoephedrine, or phenyl- propanolamine drug product if the Attorney General determines that the drug product is manufactured and distributed in a manner that prevents diversion. In making this determination the Attorney General shall consider the factors listed in subsection (d)(2) of this section. Any regulation issued pursuant to this sub- section may be amended or revoked based on the fac- tors listed in subsection (d)(4) of this section.’’ 1996—Subsec. (e). Pub. L. 104–237 added subsec. (e). Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104–237 not applicable to sale of any pseudoephedrine or phenylpropanolamine prod- uct prior to 12 months after Oct. 3, 1996, except that, on application of manufacturer of particular drug product, Attorney General may exercise sole and judicially unreviewable discretion to extend such effective date up to additional 6 months, see section 401(g) of Pub. L. 104–237, set out as a note under section 802 of this title. EFFECTIVE DATE Section effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as an Effective Date of 1993 Amendment note under section 802 of this title. PART C—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CON- TROLLED SUBSTANCES § 821. Rules and regulations The Attorney General is authorized to promul- gate rules and regulations and to charge reason- able fees relating to the registration and control of the manufacture, distribution, and dispensing of controlled substances and to listed chemicals. (Pub. L. 91–513, title II, § 301, Oct. 27, 1970, 84 Stat. 1253; Pub. L. 103–200, § 3(a), Dec. 17, 1993, 107 Stat. 2336; Pub. L. 108–447, div. B, title VI, § 633(b), Dec. 8, 2004, 118 Stat. 2922.) Editorial Notes AMENDMENTS 2004—Pub. L. 108–447 substituted ‘‘listed chemicals’’ for ‘‘the registration and control of regulated persons and of regulated transactions’’. 1993—Pub. L. 103–200 inserted before period at end ‘‘and to the registration and control of regulated per- sons and of regulated transactions’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1993 AMENDMENT Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 of this title. EFFECTIVE DATE Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title. § 822. Persons required to register (a) Period of registration (1) Every person who manufactures or distrib- utes any controlled substance or list I chemical, or who proposes to engage in the manufacture or distribution of any controlled substance or list I chemical, shall obtain annually a registration issued by the Attorney General in accordance with the rules and regulations promulgated by him. (2) Every person who dispenses, or who pro- poses to dispense, any controlled substance, shall obtain from the Attorney General a reg- istration issued in accordance with the rules and regulations promulgated by him. The Attorney General shall, by regulation, determine the pe- riod of such registrations. In no event, however, shall such registrations be issued for less than one year nor for more than three years. (3)(A) Except as provided in subparagraph (C), the registration of any registrant under this subchapter to manufacture, distribute, or dis- pense controlled substances or list I chemicals terminates if and when such registrant—