
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC814]

 
                        TITLE 21--FOOD AND DRUGS
 
              CHAPTER 13--DRUG ABUSE PREVENTION AND CONTROL
 
                  SUBCHAPTER I--CONTROL AND ENFORCEMENT
 
          Part B--Authority To Control; Standards and Schedules
 
Sec. 814. Removal of exemption of certain drugs


(a) Removal of exemption

    The Attorney General shall by regulation remove from exemption under 
section 802(39)(A)(iv) of this title a drug or group of drugs that the 
Attorney General finds is being diverted to obtain a listed chemical for 
use in the illicit production of a controlled substance.

(b) Factors to be considered

    In removing a drug or group of drugs from exemption under subsection 
(a) of this section, the Attorney General shall consider, with respect 
to a drug or group of drugs that is proposed to be removed from 
exemption--
        (1) the scope, duration, and significance of the diversion;
        (2) whether the drug or group of drugs is formulated in such a 
    way that it cannot be easily used in the illicit production of a 
    controlled substance; and
        (3) whether the listed chemical can be readily recovered from 
    the drug or group of drugs.

(c) Specificity of designation

    The Attorney General shall limit the designation of a drug or a 
group of drugs removed from exemption under subsection (a) of this 
section to the most particularly identifiable type of drug or group of 
drugs for which evidence of diversion exists unless there is evidence, 
based on the pattern of diversion and other relevant factors, that the 
diversion will not be limited to that particular drug or group of drugs.

(d) Reinstatement of exemption with respect to particular drug products

                          (1) Reinstatement

        On application by a manufacturer of a particular drug product 
    that has been removed from exemption under subsection (a) of this 
    section, the Attorney General shall by regulation reinstate the 
    exemption with respect to that particular drug product if the 
    Attorney General determines that the particular drug product is 
    manufactured and distributed in a manner that prevents diversion.

                    (2) Factors to be considered

        In deciding whether to reinstate the exemption with respect to a 
    particular drug product under paragraph (1), the Attorney General 
    shall consider--
            (A) the package sizes and manner of packaging of the drug 
        product;
            (B) the manner of distribution and advertising of the drug 
        product;
            (C) evidence of diversion of the drug product;
            (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) of this section as applied to the 
        drug product.

          (3) Status pending application for reinstatement

        A transaction involving a particular drug product that is the 
    subject of a bona fide pending application for reinstatement of 
    exemption filed with the Attorney General not later than 60 days 
    after a regulation removing the exemption is issued pursuant to 
    subsection (a) of this section shall not be considered to be a 
    regulated transaction if the transaction occurs during the pendency 
    of the application and, if the Attorney General denies the 
    application, during the period of 60 days following the date on 
    which the Attorney General denies the application, unless--
            (A) the Attorney General has evidence that, applying the 
        factors described in subsection (b) of this section 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 subsection (b) of this 
        section 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 regulation.

(e) Reinstatement of exemption with respect to ephedrine, 
        pseudoephedrine, and phenylpropanolamine drug products

    Pursuant to subsection (d)(1) of this section, the Attorney General 
shall by regulation reinstate the exemption with respect to a particular 
ephedrine, pseudoephedrine, or phenylpropanolamine 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 subsection may be amended or revoked based on the factors listed in 
subsection (d)(4) of this section.

(Pub. L. 91-513, title II, Sec. 204, as added Pub. L. 103-200, 
Sec. 2(b)(1), Dec. 17, 1993, 107 Stat. 2334; amended Pub. L. 104-237, 
title IV, Sec. 401(c), Oct. 3, 1996, 110 Stat. 3108.)


                               Amendments

    1996--Subsec. (e). Pub. L. 104-237 added subsec. (e).


                    Effective Date of 1996 Amendment

    Amendment by Pub. L. 104-237 not applicable to sale of any 
pseudoephedrine or phenylpropanolamine product 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.

                  Section Referred to in Other Sections

    This section is referred to in section 802 of this title.
