[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: 21CFR369.1]

[Page 305-306]
 
                        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-THE-COUNTER SALE--Table of Contents
 
               Subpart A--Definitions and Interpretations
 
Sec. 369.1  Purpose of issuance.


    The warning and caution statements suggested in subparts B and C of 
this part, for inclusion in the label or labeling of drugs and devices 
subject to section 502(d) and (f)(2) and other relevant

[[Page 306]]

provisions of the Federal Food, Drug, and Cosmetic Act are issued for 
the purpose of assisting industry in preparing proper labeling for these 
articles for over-the-counter sale and in meeting the legal requirements 
of the act that the label or labeling of drugs and devices bear adequate 
warnings, in such manner and form as are necessary for the protection of 
users. Only section 502(d) of the act requires use of the specific 
language included in these suggested warning and caution statements. 
These suggested warning or caution statements are illustrative of those 
that may be necessary or desirable. It is the responsibility of the 
manufacturer, packer, shipper, or distributor in interstate commerce to 
see that such statements are adequate for compliance with the provisions 
of the law. Omission of any article from this suggested list does not 
relieve drugs and devices subject to provisions of the act from bearing 
adequate warning or caution statements where such statements are 
necessary or desirable for the protection of the user.