[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: 21CFR329.10]

[Page 205-206]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--Continued
 
PART 329--HABIT-FORMING DRUGS--Table of Contents
 
                           Subpart B--Labeling
 
Sec. 329.10  Labeling requirements for habit-forming drugs.


    (a)(1) The name of a substance or derivative required to be borne on 
the label of a drug by section 502(d) of the act shall be the common or 
usual name of such substance or derivative, unless it is designated 
solely by a name recognized in an official compendium and such 
designation complies with the provisions of section 502(c).
    (2) A statement on the label of a drug of the name of a constituent, 
which constituent is a chemical derivative of a substance named in 
section 502(d) of the act, shall show the substance from which such 
constituent is derived and that such constituent is a derivative 
thereof.
    (b) If the drug is in tablet, capsule, ampul, or other unit form, 
the statement of the quantity or proportion of such substance or 
derivative contained therein shall express the weight or measure of such 
substance or derivative in each such unit. If the drug is not in such 
unit form the statement shall express the weight or measure of such 
substance or derivative in a specified unit of weight or measure of the 
drug. Such statement shall be in terms which are informative to the 
ordinary consumer and user of the drug.
    (c) The names and quantities or proportions of all such substances 
and derivatives, and the statement ``Warning--May be habit forming'', 
shall immediately follow (without intervening written, printed, or 
graphic matter) the name by which such drug is titled in the part or 
panel of the label thereof which is presented or displayed under 
customary conditions of purchase.
    (d) A drug shall not be considered to be misbranded by reason of 
failure of its label to bear the statement ``Warning--May be habit 
forming'':
    (1) If 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; or
    (2) If the only substance or derivative subject to section 502(d) of 
the act contained in such drug is chlorobutanol, which is present solely 
as a preservative and in a quantity not more than 0.5 percent by weight, 
and such drug is for parenteral use only; or
    (3) If the only substance or derivative subject to section 502(d) of 
the act contained in such drug is chlorobutanol which is present as an 
analgesic or as an analgesic and a preservative in a quantity not more 
than 3.0 percent,

[[Page 206]]

and such drug contains one or more other active ingredients and is for 
parenteral use only.

    Cross Reference: For the Spanish-language version of the required 
labeling statement, see Sec. 201.16(b) of this chapter.

[39 FR 11736, Mar. 29, 1974, as amended at 40 FR 13496, Mar. 27, 1975]