[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: 21CFR369.22]

[Page 313]
 
                        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 B--Warning and Caution Statements for Drugs
 
Sec. 369.22  Drugs; warning and caution statements specifically required by law.

PREPARATIONS CONTAINING HABIT-FORMING DERIVATIVES OF SUBSTANCES NAMED IN 
SECTION 502(d) OF THE ACT. (See Secs. 329.1, 329.10, and 329.20 of this 
chapter.)

    The statement ``Warning--May be habit forming'' is required to 
appear on the labels of all drugs containing derivatives designated in 
Sec. 329.1 of this chapter as habit forming, including exempt narcotic 
preparations described in Sec. 329.20(a) of this chapter and 
preparations containing one or more derivatives of barbituric acid, 
unless such drug is not suitable for internal use and is distributed and 
sold exclusively for such external use as involves no possibility of 
habit formation.