[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: 21CFR369.3]

[Page 324-325]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 369_INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES
FOR OVER-THE-COUNTER SALE--Table of Contents
 
                Subpart A_Definitions and Interpretations
 
Sec. 369.3  Warnings required on drugs exempted from 

prescription-dispensing requirements of section 503(b)(1)(C).

    Drugs exempted from prescription-dispensing requirements under 
section 503(b)(1)(C) of the act are subject to the labeling requirements 
prescribed in Sec. 310.201(a) of this chapter. Although, for 
convenience, warning and caution statements for a number of the drugs 
named in Sec. 310.201 of this chapter (cross-referenced in the text of 
this part) are included in subpart B of this part, the inclusion of such 
drugs in Sec. Sec. 369.20, 369.21, 369.22 in no way affects the 
requirements for compliance with

[[Page 325]]

Sec. 310.201(a) of this chapter, or the provisions of an effective 
application pursuant to section 505(b) of the act.