[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR314.161]

[Page 156-157]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 314_APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG--
Table of Contents
 
    Subpart D_FDA Action on Applications and Abbreviated Applications
 
Sec. 314.161  Determination of reasons for voluntary withdrawal of a listed drug.

    (a) A determination whether a listed drug that has been voluntarily 
withdrawn from sale was withdrawn for safety or effectiveness reasons 
may be made by the agency at any time after the drug has been 
voluntarily withdrawn from sale, but must be made:
    (1) Prior to approving an abbreviated new drug application that 
refers to the listed drug;
    (2) Whenever a listed drug is voluntarily withdrawn from sale and 
abbreviated new drug applications that referred to the listed drug have 
been approved; and
    (3) When a person petitions for such a determination under 
Sec. Sec. 10.25(a) and 10.30 of this chapter.
    (b) Any person may petition under Sec. Sec. 10.25(a) and 10.30 of 
this chapter for a determination whether a listed drug has been 
voluntarily withdrawn for safety or effectiveness reasons. Any such 
petition must contain all evidence available to the petitioner 
concerning the reason that the drug is withdrawn from sale.
    (c) If the agency determines that a listed drug is withdrawn from 
sale for safety or effectiveness reasons, the agency will, except as 
provided in paragraph (d) of this section, publish a notice of the 
determination in the Federal Register.
    (d) If the agency determines under paragraph (a) of this section 
that a listed drug is withdrawn from sale for

[[Page 157]]

safety and effectiveness reasons and there are approved abbreviated new 
drug applications that are subject to suspension under section 505(j)(5) 
of the act, FDA will initiate a proceeding in accordance with Sec. 
314.153(b).
    (e) A drug that the agency determines is withdrawn for safety or 
effectiveness reasons will be removed from the list, under Sec. 
314.162. The drug may be relisted if the agency has evidence that 
marketing of the drug has resumed or that the withdrawal is not for 
safety or effectiveness reasons. A determination that the drug is not 
withdrawn for safety or effectiveness reasons may be made at any time 
after its removal from the list, upon the agency's initiative, or upon 
the submission of a petition under Sec. Sec. 10.25(a) and 10.30 of this 
chapter. If the agency determines that the drug is not withdrawn for 
safety or effectiveness reasons, the agency shall publish a notice of 
this determination in the Federal Register. The notice will also 
announce that the drug is relisted, under Sec. 314.162(c). The notice 
will also serve to reinstate approval of all suspended abbreviated new 
drug applications that referred to the listed drug.

[57 FR 17995, Apr. 28, 1992]