[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.10]

[Page 12-14]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 201_LABELING--Table of Contents
 
                  Subpart A_General Labeling Provisions
 
Sec. 201.10  Drugs; statement of ingredients.

    (a) The ingredient information required by section 502(e) of the 
Federal Food, Drug, and Cosmetic Act shall appear together, without any 
intervening written, printed, or graphic matter, except the proprietary 
names of ingredients, which may be included with the listing of 
established names, and such statements that are specifically required 
for certain ingredients by the act or regulations in this chapter.
    (b) The term ingredient applies to any substance in the drug, 
whether added to the formulation as a single substance or in admixture 
with other substances.
    (c) The labeling of a drug may be misleading by reason (among other 
reasons) of:
    (1) The order in which the names of the ingredients present in the 
drug appear in the labeling, or the relative prominence otherwise given 
such names.
    (2) Failure to reveal the proportion of, or other fact with respect 
to, an ingredient present in such drug, when such proportion or other 
fact is material in the light of the representation that such ingredient 
is present in such drug.
    (3) The employment of a fanciful proprietary name for a drug or 
ingredient in such a manner as to imply that the drug or ingredient has 
some unique effectiveness or composition when, in fact, the drug or 
ingredient is a common substance, the limitations of which are readily 
recognized when the drug or ingredient is listed by its established 
name.
    (4) The featuring in the labeling of inert or inactive ingredients 
in a manner that creates an impression of value greater than their true 
functional role in the formulation.
    (5) Designation of a drug or ingredient by a proprietary name that, 
because of similarity in spelling or pronunciation, may be confused with 
the proprietary name or the established name of a different drug or 
ingredient.
    (d)(1) If the drug is in tablet or capsule form or other unit dosage 
form, any statement of the quantity of an ingredient contained therein 
shall express the quantity of such ingredient in each such unit. If the 
drug is not in unit dosage form, any statement of the quantity of an 
ingredient contained therein shall express the amount of such ingredient 
in a specified unit of weight or measure of the drug, or the percentage 
of such ingredient in such drug. Such statements shall be in terms that 
are informative to licensed

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practitioners, in the case of a prescription drug, and to the layman, in 
the case of a nonprescription drug.
    (2) A statement of the percentage of an ingredient in a drug shall, 
if the term percent is used without qualification, mean percent weight-
in-weight, if the ingredient and the drug are both solids, or if the 
ingredient is a liquid and the drug is a solid; percent weight in volume 
at 68 [deg]F. (20 [deg]C.), if the ingredient is a solid and the drug is 
a liquid; and percent volume in volume at 68 [deg]F. (20 [deg]C.), if 
both the ingredient and the drug are liquids, except that alcohol shall 
be stated in terms of percent volume of absolute alcohol at 60 [deg]F. 
(15.56 [deg]C.).
    (e) A derivative or preparation of a substance named in section 
502(e) of the act is an article derived or prepared from such substance 
by any method, including actual or theoretical chemical action.
    (f) If an ingredient is a derivative or preparation of a substance 
specifically named in section 502(e) of the act and the established name 
of such ingredient does not indicate that it is a derivative or 
preparation of the parent substance named in section 502(e) of the act, 
the labeling shall, in conjunction with the listing of the established 
name of such ingredient, declare that such article is a derivative or 
preparation of such parent substance.
    (g)(1) If the label or labeling of a prescription drug bears a 
proprietary name or designation for the drug or any ingredient thereof, 
the established name, if such there be, corresponding to such 
proprietary name or designation shall accompany such proprietary name or 
designation each time it is featured on the label or in the labeling for 
the drug; but, except as provided in this subparagraph, the established 
name need not be used with the proprietary name or designation in the 
running text of the label or labeling. On any label or page of labeling 
in which the proprietary name or designation is not featured but is used 
in the running text, the established name shall be used at least once in 
the running text in association with such proprietary name or 
designation and in the same type size used in such running text: 
Provided, however, That if the proprietary name or designation is used 
in the running text in larger size type, the established name shall be 
used at least once in association with, and in type at least half as 
large as the type used for, the most prominent presentation of the 
proprietary name or designation in such running text. If any labeling 
includes a column with running text containing detailed information as 
to composition, prescribing, side effects, or contraindications and the 
proprietary name or designation is used in such column but is not 
featured above or below the column, the established name shall be used 
at least once in such column of running text in association with such 
proprietary name or designation and in the same type size used in such 
column of running text: Provided, however, That if the proprietary name 
or designation is used in such column of running text in larger size 
type, the established name shall be used at least once in association 
with, and in type at least half as large as the type used for, the most 
prominent presentation of the proprietary name or designation in such 
column of running text. Where the established name is required to 
accompany or to be used in association with the proprietary name or 
designation, the established name shall be placed in direct conjunction 
with the proprietary name or designation, and the relationship between 
the proprietary name or designation and the established name shall be 
made clear by use of a phrase such as ``brand of'' preceding the 
established name, by brackets surrounding the established name, or by 
other suitable means.
    (2) The established name shall be printed in letters that are at 
least half as large as the letters comprising the proprietary name or 
designation with which it is joined, and the established name shall have 
a prominence commensurate with the prominence with which such 
proprietary name or designation appears, taking into account all 
pertinent factors, including typography, layout, contrast, and other 
printing features.
    (h)(1) In the case of a prescription drug containing two or more 
active ingredients, if the label bears a proprietary name or designation 
for such mixture and there is no established

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name corresponding to such proprietary name or designation, the 
quantitative ingredient information required on the label by section 
502(e) of the act shall be placed in direct conjunction with the most 
prominent display of the proprietary name or designation. The prominence 
of the quantitative ingredient information shall bear a reasonable 
relationship to the prominence of the proprietary name.
    (2) If the drug is packaged in a container too small to bear the 
quantitative ingredient information on the main display panel, the 
quantitative ingredient information required by section 502(e) of the 
act may appear elsewhere on the label, even though the proprietary name 
or designation appears on the main display panel of the label; but side- 
or back-panel placement shall in this case be so arranged and printed as 
to provide size and prominence of display reasonably related to the size 
and prominence of the front-panel display.
    (i) A drug packaged in a container too small or otherwise unable to 
accommodate a label with sufficient space to bear the information 
required for compliance with section 502(e)(1) (A)(ii) and (B) of the 
act shall be exempt from compliance with those clauses: Provided, That:
    (1) The label bears:
    (i) The proprietary name of the drug;
    (ii) The established name, if such there be, of the drug;
    (iii) An identifying lot or control number; and
    (iv) The name of the manufacturer, packer, or distributor of the 
drug; and
    (2) All the information required to appear on the label by the act 
and the regulations in this chapter appears on the carton or other outer 
container or wrapper if such carton, outer container, or wrapper has 
sufficient space to bear such information, or such complete label 
information appears on a leaflet with the package.

[40 FR 13998, Mar. 27, 1975, as amended at 67 FR 4906, Feb. 1, 2002]