Section 22-B10308. DECLARATION OF NET QUANTITY OF CONTENTS

 

10308.1The label of an over-the-counter device in package form shall bear a declaration of the net quantity of contents.  This shall be expressed in terms of weight, measure, numerical count, or a combination of numerical count and weight, measure, or size, provided that:

 

(a)In the case of a firmly established general consumer usage and trade custom of declaring the quantity of a device in terms of linear measure or measure of area, the respective term may be used.  The 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 device; or  

 

(b)If the declaration of contents for a device by numerical count does not give accurate information as to the quantity of the device in the package, it shall be augmented by such statement of weight, measure, or size of the individual units or of the total weight, measure, or size of the device as will give such information.  For example, “one hundred (100) tongue depressors, adult size,” and “one (1) rectal syringe, adult size.”  Whenever the Director determines for a specified packaged device 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 or she shall, by regulation, designate the appropriate term or terms to be used for the medical device.

 

10308.2Statements of weight of the contents shall be expressed in terms of avoirdupois pound and ounce.  Statements of liquid measure of the contents shall be expressed in terms of the U.S. gallon of two hundred thirty-one cubic inches (231 cu. in.) and quart, pint, and fluid-ounce subdivisions thereof, and shall express the volume at sixty-eight degrees Fahrenheit (68 °F) (twenty degrees Celsius (20 °C)).

 

10308.3The declaration may contain common or decimal fractions.  A common fraction shall be in terms of halves, quarters, eighths, 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 (2) 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. 

 

10308.4The 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. 

 

10308.5The declaration shall appear as a distinct item on the principal display panel, and shall be separated from other printed label information appearing to the left or right of the declaration by a space at least equal to the height of the lettering used in the declaration.  It shall not include any term qualifying a unit of weight, measure, or count, such as “giant pint” or “full quart,” that tends to exaggerate.  It shall be placed on the principal display panel within the bottom thirty percent (30%) 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:

 

(a) On packages having a principal display panel of five square inches (5 sq. in.) or less the requirement for placement within the bottom thirty percent (30%) 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;

 

(b) In the case of a device 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; and

 

(c) The principal display panel of a device 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.

 

10308.6The declaration shall accurately state the quantity of device in the package exclusive of wrappers and other material packed therewith.

 

10308.7The declaration shall appear in conspicuous and easily legible bold face 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. 

 

10308.8Requirements of conspicuousness and legibility shall include the specifications that:

 

(a) The ratio of height to width of the letter shall not exceed a differential of three (3) units to one (1) unit, in other words, no more than three (3) times as high as it is wide;

 

(b)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; and

 

(c)When fractions are used, each component numeral shall meet one-half (1/2) the minimum height standards.

 

10308.9The 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:

 

(a)Not less than one-sixteenth inch (1/16 in.) in height on packages the principal display panel of which has an area of five square inches (5 sq. in.) or less;

 

(b)  Not less than one-eighth inch (1/8 in.) in height on packages the principal display panel of which has an area of more than five (5) but not more than twenty-five square inches (25 sq. in.);

 

(c)Not less than three-sixteenths inch (3/16 in.) in height on packages the principal display panel of which has an area of more than twenty-five (25) but not more than one hundred square inches (100 sq. in.); and

 

(d)Not less than one-quarter inch (1/4 in.) in height on packages the principal display panel of which has an area of more than one hundred square inches (100 sq. in.), except not less than one-half inch (1/2 in.) in height if the area is more than four hundred square inches (400 sq. in.).

 

10308.10Where 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 § 10308.9(a) - (d) shall be increased by one-sixteenth inch (1/16 in.).

 

10308.11On packages containing less than four pounds (4 lbs.) or one gallon (1 gal.) and labeled in terms of weight or fluid measure, the declaration shall be expressed both in ounces, with identification by weight or by liquid measure and, if applicable (one pound (1 lb.) or one pint (1 pt.) or more) followed in parentheses by a declaration in pounds for weight units, with, with any remainder in terms of ounces or common or decimal fractions of the pound, 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.  If the net weight of the package is less than one ounce (1 oz.) avoirdupois or the net fluid measure is less than one fluid ounce (1 fl. oz.), the declaration shall be in terms of common or decimal fractions of the respective ounce and not in terms of drams;  

 

10308.12Pursuant to § 10308.11, 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. six (6) oz.” or “six (6) oz. net wt.,” and “six (6) fl. oz.” or “net contents six (6) fl. oz.”

 

10308.13On packages containing four pounds (4 lbs.) or one gallon (1 gal.) 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 (such as gallons) followed by common or decimal fractions or 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.

 

10308.14Pursuant to § 10308.13, examples are:

 

(a) A declaration of one and one half pounds (1-1/2 lbs.) 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.);”

 

(b)    A declaration of three-fourths pound (3/4 lb.) avoirdupois weight shall be expressed as “Net wt. 12. oz.;”

 

(c)A declaration of one quart (1 qt.) liquid measure shall be expressed as “Net contents 32 fl. oz. (1 qt.).” 

 

(a) A declaration of one and three fourths quarts (1-3/4 qts.) liquid measure shall be expressed as “Net contents 56 fl. oz. (1 qt. 1.5 pt.),” but not in terms of quart and ounce such as “Net contents 56 fl. oz. (1 qt. 24 oz.);” or

 

(e)A declaration of two and one half gallons (2-1/2 gals.) 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.”

 

10308.15Pursuant to § 10308.14, for quantities, the following abbreviations and none other may be employed.  Periods and plural forms are optional:

 

gallon – gal.liter – l

milliliter – mlcubic centimeter – cc

quart – qt.yard – yd.

pint – pt.feet or foot – ft.

ounce – oz.inch – in.

pound – lb.meter – m

grain – gr.centimeter – cm

kilogram – kgmillimeter – mm

gram – gfluid – fl.

milligram – mgsquare – sq.

microgram – mcgweight – wt.

 

10308.16On packages labeled in terms of linear measure, the declaration shall be expressed both in terms of inches and, if applicable (one foot (1 ft.)) 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 (2yd, 1 ft. 2 in.)”, “90 inches (2-1/2 yd.),” “30 inches (2.5 ft.),” and “3/4 inch by 36 in. (1 yd.).”

 

10308.17On packages labeled in terms of area measure, the declaration shall be expressed both in terms of square inches and, if applicable one square foot (1 sq. ft.) 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.)."

 

10308.18Nothing in this section shall prohibit supplemental statements at locations other than the principal display panel(s) describing in non-deceptive 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 device contained in the package; for example, "giant pint" or "full quart."  Dual or combination declarations of net quantity of contents are not regarded as supplemental net quantity statements and shall be located on the principal display panel.

 

10308.19A 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.

 

10308.20The 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.

 

 

authority

Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor’s Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor’s Order 98-88, dated May 29, 1998.

source

Final Rulemaking published at 60 DCR 10252 (July 12, 2013).