[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
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
[[Page 13]]
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
[[Page 14]]
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]
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