[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR314.162]

[Page 150-151]
 
                        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. 314.162  Removal of a drug product from the list.

    (a) FDA will remove a previously approved new drug product from the 
list for the period stated when:
    (1) The agency withdraws or suspends approval of a new drug 
application or an abbreviated new drug application under Sec. 314.150(a) 
or Sec. 314.151 or under the imminent hazard authority of section 505(e) 
of the act, for the same period as the withdrawal or suspension of the 
application; or
    (2) The agency, in accordance with the procedures in Sec. 314.153(b) 
or Sec. 314.161, issues a final decision stating that the listed drug 
was withdrawn from sale for safety or effectiveness reasons, or 
suspended under Sec. 314.153(b), until the agency determines that the 
withdrawal from the market has ceased or is not for safety or 
effectiveness reasons.
    (b) FDA will publish in the Federal Register a notice announcing the 
removal of a drug from the list.

[[Page 151]]

    (c) At the end of the period specified in paragraph (a)(1) or (a)(2) 
of this section, FDA will relist a drug that has been removed from the 
list. The agency will publish in the Federal Register a notice 
announcing the relisting of the drug.

[57 FR 17996, Apr. 28, 1992]