
From the U.S. Code Online via GPO Access
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[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC335c]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
              SUBCHAPTER III--PROHIBITED ACTS AND PENALTIES
 
Sec. 335c. Authority to withdraw approval of abbreviated drug 
        applications
        

(a) In general

    The Secretary--
        (1) shall withdraw approval of an abbreviated drug application 
    if the Secretary finds that the approval was obtained, expedited, or 
    otherwise facilitated through bribery, payment of an illegal 
    gratuity, or fraud or material false statement, and
        (2) may withdraw approval of an abbreviated drug application if 
    the Secretary finds that the applicant has repeatedly demonstrated a 
    lack of ability to produce the drug for which the application was 
    submitted in accordance with the formulations or manufacturing 
    practice set forth in the abbreviated drug application and has 
    introduced, or attempted to introduce, such adulterated or 
    misbranded drug into commerce.

(b) Procedure

    The Secretary may not take any action under subsection (a) of this 
section with respect to any person unless the Secretary has issued an 
order for such action made on the record after opportunity for an agency 
hearing on disputed issues of material fact. In the course of any 
investigation or hearing under this subsection, the Secretary may 
administer oaths and affirmations, examine witnesses, receive evidence, 
and issue subpoenas requiring the attendance and testimony of witnesses 
and the production of evidence that relates to the matter under 
investigation.

(c) Applicability

    Subsection (a) of this section shall apply with respect to offenses 
or acts regardless of when such offenses or acts occurred.

(d) Judicial review

    Any person that is the subject of an adverse decision under 
subsection (a) of this section may obtain a review of such decision by 
the United States Court of Appeals for the District of Columbia or for 
the circuit in which the person resides, by filing in such court (within 
60 days following the date the person is notified of the Secretary's 
decision) a petition requesting that the decision be modified or set 
aside.

(June 25, 1938, ch. 675, Sec. 308, as added Pub. L. 102-282, Sec. 4, May 
13, 1992, 106 Stat. 160.)


                              Construction

    This section not to preclude any other civil, criminal, or 
administrative remedy provided under Federal or State law, including any 
private right of action against any person for the same action subject 
to any action or civil penalty under an amendment made by Pub. L. 102-
282, see section 7 of Pub. L. 102-282, set out as a note under section 
335a of this title.

                  Section Referred to in Other Sections

    This section is referred to in section 321 of this title.
