[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: 21CFR201.62]
[Page 39-42]
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 C Labeling Requirements for Over-the-Counter Drugs
Sec. 201.62 Declaration of net quantity of contents.
(a) The label of an over-the-counter drug in package form shall bear
a declaration of the net quantity of contents. This shall be expressed
in the terms of weight, measure, numerical count, or a combination or
numerical count and weight, measure, or size. The statement of quantity
of drugs in tablet, capsule, ampule, or other unit form and the quantity
of devices shall be expressed in terms of numerical count; the statement
of quantity for drugs in other dosage forms shall be in terms of weight
if the drug is solid, semisolid, or viscous, or in terms of fluid
measure if the drug is liquid. The drug quantity statement shall be
augmented when necessary to give accurate information as to the strength
of such drug in the package; for example, to differentiate between
several strengths of the same drug ``100 tablets, 5 grains each'' or
``100 capsules, 125 milligrams each'' or ``100 capsules, 250 milligrams
each'': Provided, That:
(1) In the case of a firmly established, general consumer usage and
trade custom of declaring the quantity of a drug in terms of linear
measure or measure of area, such respective term may be used. Such term
shall be augmented when necessary for accuracy of information by a
statement of the weight, measure, or size of the individual units or of
the entire drug; for example, the net quantity of adhesive tape in
package form shall be expressed in terms of linear measure augmented by
a statement of its width.
(2) Whenever the Commissioner determines for a specific packaged
drug that an existing practice of declaring net quantity of contents by
weight, measure, numerical count, or a combination of these does not
facilitate value comparisons by consumers, he shall by regulation
designate the appropriate term or terms to be used for such article.
(b) Statements of weight of the contents shall be expressed in terms
of avoirdupois pound and ounce. A statement of liquid measure of the
contents shall be expressed in terms of the U.S. gallon of 231 cubic
inches and quart, pint, and fluid-ounce subdivisions thereof, and shall
express the volume at 68 [deg]F (20 [deg]C). See also paragraph (p) of
this section.
(c) The declaration may contain common or decimal fractions. A
common fraction shall be in terms of halves,
[[Page 40]]
quarters, eights, sixteenths, or thirty-seconds; except that if there
exists a firmly established, general consumer usage and trade custom of
employing different common fractions in the net quantity declaration of
a particular commodity, they may be employed. A common fraction shall be
reduced to its lowest terms; a decimal fraction shall not be carried out
to more than two places. A statement that includes small fractions of an
ounce shall be deemed to permit smaller variations than one which does
not include such fractions.
(d) The declaration shall be located on the principal display panel
of the label, and with respect to packages bearing alternate principal
panels it shall be duplicated on each principal display panel.
(e) The declaration shall appear as a distinct item on the principal
display panel, shall be separated, by at least a space equal to the
height of the lettering used in the declaration, from other printed
label information appearing above or below the declaration and, by at
least a space equal to twice the width of the letter ``N'' of the style
of type used in the quantity of contents statement, from other printed
label information appearing to the left or right of the declaration. It
shall not include any term qualifying a unit of weight, measure, or
count, such as ``giant pint'' and ``full quart'', that tends to
exaggerate the amount of the drug in the container. It shall be placed
on the principal display panel within the bottom 30 percent of the area
of the label panel in lines generally parallel to the base on which the
package rests as it is designed to be displayed: Provided, That:
(1) On packages having a principal display panel of 5 square inches
or less the requirement for placement within the bottom 30 percent of
the area of the label panel shall not apply when the declaration of net
quantity of contents meets the other requirements of this part; and
(2) In the case of a drug that is marketed with both outer and inner
retail containers bearing the mandatory label information required by
this part and the inner container is not intended to be sold separately,
the net quantity of contents placement requirement of this section
applicable to such inner container is waived.
(3) The principal display panel of a drug marketed on a display card
to which the immediate container is affixed may be considered to be the
display panel of the card, and the type size of the net quantity of
contents statement is governed by the dimensions of the display card.
(f) The declaration shall accurately reveal the quantity of drug or
device in the package exclusive of wrappers and other material packed
therewith: Provided, That in the case of drugs packed in containers
designed to deliver the drug under pressure, the declaration shall state
the net quantity of the contents that will be expelled when the
instructions for use as shown on the container are followed. The
propellant is included in the net quantity declaration.
(g) The declaration shall appear in conspicuous and easily legible
boldface print or type in distinct contrast (by typography, layout,
color, embossing, or molding) to other matter on the package; except
that a declaration of net quantity blown, embossed, or molded on a glass
or plastic surface is permissible when all label information is so
formed on the surface. Requirements of conspicuousness and legibility
shall include the specifications that:
(1) The ratio of height to width of the letter shall not exceed a
differential of 3 units to 1 unit, i.e., no more than 3 times as high as
it is wide.
(2) Letter heights pertain to upper case or capital letters. When
upper and lower case or all lower case letters are used, it is the lower
case letter ``o'' or its equivalent that shall meet the minimum
standards.
(3) When fractions are used, each component numeral shall meet one-
half the minimum height standards.
(h) The declaration shall be in letters and numerals in a type size
established in relationship to the area of the principal display panel
of the package and shall be uniform for all packages of substantially
the same size by complying with the following type specifications:
[[Page 41]]
(1) Not less than one-sixteenth inch in height on packages the
principal display panel of which has an area of 5 square inches or less.
(2) Not less than one-eighth inch in height on packages the
principal display panel of which has an area of more than five but not
more than 25 square inches.
(3) Not less than three-sixteenths inch in height on packages the
principal display panel of which has an area of more than 25 but not
more than 100 square inches.
(4) Not less than one-fourth inch in height on packages the
principal display panel of which has an area of more than 100 square
inches, except not less than one-half inch in height if the area is more
than 400 square inches.
Where the declaration is blown, embossed, or molded on a glass or
plastic surface rather than by printing, typing, or coloring, the
lettering sizes specified in paragraphs (h) (1) through (4) of this
section shall be increased by one-sixteenth of an inch.
(i) On packages containing less than 4 pounds or 1 gallon and
labeled in terms of weight or fluid measure:
(1) The declaration shall be expressed both in ounces, with
identification by weight or by liquid measure and, if applicable (1
pound or 1 pint or more) followed in parentheses by a declaration in
pounds for weight units, with any remainder in terms of ounces or common
or decimal fractions of the pound (see examples set forth in paragraphs
(k) (1) and (2) of this section), or in the case of liquid measure, in
the largest whole units (quarts, quarts and pints, or pints, as
appropriate) with any remainder in terms of fluid ounces or common or
decimal fractions of the pint or quart (see examples set forth in
paragraphs (k) (3) and (4) of this section). If the net weight of the
package is less than 1 ounce avoirdupois or the net fluid measure is
less than 1 fluid ounce, the declaration shall be in terms of common or
decimal fractions of the respective ounce and not in terms of drams.
(2) The declaration may appear in more than one line. The term net
weight shall be used when stating the net quantity of contents in terms
of weight. Use of the terms net or net contents in terms of fluid
measure or numerical count is optional. It is sufficient to distinguish
avoirdupois ounce from fluid ounce through association of terms; for
example, ``Net wt. 6 oz'' or ``6 oz net wt.,'' and ``6 fl oz'' or ``net
contents 6 fl oz''.
(j) On packages containing 4 pounds or 1 gallon or more and labeled
in terms of weight or fluid measure, the declaration shall be expressed
in pounds for weight units with any remainder in terms of ounces or
common or decimal fractions of the pound; in the case of fluid measure,
it shall be expressed in the largest whole unit (gallons, followed by
common or decimal fractions of a gallon or by the next smaller whole
unit or units (quarts or quarts and pints)) with any remainder in terms
of fluid ounces or common or decimal fractions of the pint or quart; see
paragraph (k)(5) of this section.
(k) Examples:
(1) A declaration of 1\1/2\ pounds weight shall be expressed as
``Net wt. 24 oz (1 lb 8 oz),'' or ``Net wt. 24 oz (1\1/2\ lb)'' or ``Net
wt. 24 oz (1.5 lb)''.
(2) A declaration of three-fourths pound avoirdupois weight shall be
expressed as ``Net wt. 12 oz''.
(3) A declaration of 1 quart liquid measure shall be expressed as
``Net contents 32 fl oz (1 qt)'' or ``32 fl oz (1 qt)''.
(4) A declaration of 1\3/4\ quarts liquid measure shall be expressed
as ``Net contents 56 fl oz (1 qt 1 pt 8 oz)'' or ``Net contents 56 fl oz
(1 qt 1.5 pt),'' but not in terms of quart and ounce such as ``Net 56 fl
oz (1 qt 24 oz).''
(5) A declaration of 2\1/2\ gallons liquid measure shall be
expressed as ``Net contents 2 gal 2 qt,'' ``Net contents 2.5 gallons,''
or ``Net contents 2\1/2\ gal'' but not as ``2 gal 4 pt''.
(l) For quantities, the following abbreviations and none other may
be employed. Periods and plural forms are optional:
Gallon gal
quart qt
pint pt
ounce oz
pound lb
grain gr
kilogram kg
gram g
milligram mg
microgram mcg
liter l
milliliter ml
cubic centimeter cc
yard yd
feet or foot ft
inch in
[[Page 42]]
meter m
centimeter cm
millimeter mm
fluid fl
square sq
weight wt
(m) On packages labeled in terms of linear measure, the declaration
shall be expressed both in terms of inches and, if applicable (1 foot or
more), the largest whole units (yards, yards and feet, feet). The
declaration in terms of the largest whole units shall be in parentheses
following the declaration in terms of inches and any remainder shall be
in terms of inches or common or decimal fractions of the foot or yard;
if applicable, as in the case of adhesive tape, the initial declaration
in linear inches shall be preceded by a statement of the width. Examples
of linear measure are ``86 inches (2 yd 1 ft 2 in),'' ``90 inches (2\1/
2\ yd),'' ``30 inches (2.5 ft),'' `` \3/4\ inch by 36 in (1 yd),'' etc.
(n) On packages labeled in terms of area measure, the declaration
shall be expressed both in terms of square inches and, if applicable (1
square foot or more), the largest whole square unit (square yards,
square yards and square feet, square feet). The declaration in terms of
the largest whole units shall be in parentheses following the
declaration in terms of square inches and any remainder shall be in
terms of square inches or common or decimal fractions of the square foot
or square yard; for example, ``158 sq inches (1 sq ft 14 sq in).''
(o) Nothing in this section shall prohibit supplemental statements
at locations other than the principal display panel(s) describing in
nondeceptive terms the net quantity of contents, provided that such
supplemental statements of net quantity of contents shall not include
any term qualifying a unit of weight, measure, or count that tends to
exaggerate the amount of the drug contained in the package; for example,
``giant pint'' and ``full quart.'' Dual or combination declarations of
net quantity of contents as provided for in paragraphs (a) and (i) of
this section are not regarded as supplemental net quantity statements
and shall be located on the principal display panel.
(p) A separate statement of net quantity of contents in terms of the
metric system of weight or measure is not regarded as a supplemental
statement and an accurate statement of the net quantity of contents in
terms of the metric system of weight or measure may also appear on the
principal display panel or on other panels.
(q) The declaration of net quantity of contents shall express an
accurate statement of the quantity of contents of the package.
Reasonable variations caused by loss or gain of moisture during the
course of good distribution practice or by unavoidable deviations in
good manufacturing practice will be recognized. Variations from stated
quantity of contents shall not be unreasonably large.
(r) A drug shall be exempt from compliance with the net quantity
declaration required by this section if it is an ointment labeled
``sample,'' ``physician's sample,'' or a substantially similar statement
and the contents of the package do not exceed 8 grams.
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