[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR369.3]

[Page 325]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 369_INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-
 
                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 Sec.  310.201(a) of this chapter, or 
the provisions of an effective application pursuant to section 505(b) of 
the act.