[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR314.161]

[Page 159-160]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--Continued
 
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withdrawn from sale was withdrawn for safety or effectiveness reasons 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voluntarily withdrawn from sale, but must be made: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    (2) Whenever a listed drug is voluntarily withdrawn from sale and 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 
Secs. 10.25(a) and 10.30 of this chapter.
    (b) Any person may petition under Secs. 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withdrawn for safety or effectiveness reasons.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that the drug is withdrawn from sale.
    (c) If the agency determines that a listed drug is withdrawn from 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that a listed drug is withdrawn from sale for safety and effectiveness 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    (e) A drug that the agency determines is withdrawn for safety or 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

[[Page 160]]

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 A determination that the drug is not withdrawn for safety or 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 Secs. 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]