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of the act and by the regulations in thereof, and shall express the volume this part.
at 68 °F (20 °C). See also paragraph (p) (C) The statement of identity shall be of this section. presented in bold face type on the prin- (c) The declaration may contain comcipal display panel, shall be in a size mon or decimal fractions. A common reasonably related to the most promi- fraction shall be in terms of halves, nent printed matter on such panel, and quarters, eighths, sixteenths, or thirtyshall be in lines generally parallel to seconds; except that if there exists a the base on which the package rests as firmly established, general consumer it is designed to be displayed.
usage and trade custom of employing
different common fractions in the net $801.62 Declaration of net quantity of
quantity declaration of a particular contents.
commodity, they may be employed. A (a) The label of an over-the-counter common fraction shall be reduced to device in package form shall bear a its lowest terms; a decimal fraction declaration of the net quantity of con- shall not be carried out to more than tents. This shall be expressed in the two places. A statement that includes terms of weight, measure, numerical small fractions of an ounce shall be count, or a combination of numerical deemed to permit smaller variations count and weight, measure, or size: than one which does not include such Provided, That:
fractions. (1) In the case of a firmly established (d) The declaration shall be located general consumer usage and trade cus- on the principal display panel of the tom of declaring the quantity of a de- label, and with respect to packages vice in terms of linear measure bearing alternate principal panels it measure of area, such respective term shall be duplicated on each principal may be used. Such term shall be aug- display panel. mented when necessary for accuracy of (e) The declaration shall appear as a information by a statement of the distinct item on the principal display weight, measure, or size of the indi- panel, shall be separated, by at least a vidual units or of the entire device. space equal to the height of the let
(2) If the declaration of contents for a tering used in the declaration, from device by numerical count does not other printed label information appeargive accurate information as to the ing above or below the declaration and, quantity of the device in the package, by at least a space equal to twice the it shall be augmented by such state- width of the letter “N” of the style of ment of weight, measure, or size of the type used in the quantity of contents individual units or of the total weight, statement, from other printed label inmeasure, or size of the device as will formation appearing to the left or right give such information; for example, of the declaration. It shall not include “100 tongue depressors, adult size”, “1 any term qualifying a unit of weight, rectal syringe, adult size”, etc. When- measure, or count, such as “giant pint” ever the Commissioner determines for and "full quart”, that tends to exaga specific packaged device that an ex- gerate. It shall be placed on the prinisting practice of declaring net quan- cipal display panel within the bottom tity of contents by weight, measure, 30 percent of the area of the label panel numerical count, or a combination of in lines generally parallel to the base these does not facilitate value on which the package rests as it is decomparisions by consumers, he shall by signed to be displayed: Provided, That: regulation designate the appropriate (1) On packages having a principal term or terms to be used for such arti- display panel of 5 square inches or less cle.
the requirement for placement within (b) Statements of weight of the con- the bottom 30 percent of the area of the tents shall be expressed in terms of av- label panel shall not apply when the oirdupois pound and ounce. A state- declaration of net quantity of contents ment of liquid measure of the contents meets the other requirements of this shall be expressed in terms of the U.S. part; and gallon of 231 cubic inches and quart, (2) In the case of a device that is marpint, and fluid-ounce subdivisions keted 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 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.
(f) The declaration shall accurately reveal the quantity of device in the package exclusive of wrappers and other material packed therewith.
(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 onehalf 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:
(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 5 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 i 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, i.e., gallons, followed by common or decimal fractions of a gallon or by the next smaller whole unit 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 142 pounds weight shall be expressed as "net wt. 24 oz (1 lb 8 oz)," or "Net wt. 24 oz (142 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 134 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 contents 56 fl oz (1 qt 24 oz)."
(5) A declaration of 242 gallons liquid measure shall be expressed as “Net contents 2 gal 2 qt”, “Net contents 2.5 gallons,” or “Net contents 21/2 gal" but not as "2 gal 4 pt”.
(1) For quantities, the following abbreviations and none other may be employed. Periods and plural forms are optional: gallon gal milliliter mi
cubic centimeter cc quart at
yard yd pint pt
teet or foot ft
inch in pound lb
meter m grain gr
centimeter cm kilogram kg
millimeter mm gram g
fluid fl milligram mg
square sa microgram mcg
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 pa
rentheses 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 (242 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)”.
(0) 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 device 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
Subpart D-Exemptions From Adequate Directions for Use
practice or by unavoidable deviations in good manufacturing practice will be recognized. Variations from stated quantity of contents shall not be unreasonably large. $ 801.63 Medical devices; warning statements for devices containing manufactured
with chlorofluorocarbons and other class
I ozone-depleting substances. (a) All over-the-counter devices containing or manufactured with chlorofluorocarbons, halons, carbon tetrachloride, methyl chloride, or any other class I substance designated by the Environmental Protection Agency (EPA) shall carry one of the following warnings:
(1) The EPA warning statement: WARNING: Contains (or Manufactured with, if applicable) (insert name of substance), a substance which harms public health and environment by destroying ozone in the upper atmosphere.
(2) The alternative statement: NOTE: The indented statement below is required by the Federal government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFC's) (or other class I substance, if applicable):
WARNING: Contains (or Manufactured with, if applicable) (insert name of substance), a substance which harms public health and environment by destroying ozone in the upper atmosphere.
CONSULT WITH YOUR PHYSICIAN, HEALTH PROFESSIONAL, OR SUPPLIER IF YOU HAVE ANY QUESTION ABOUT THE USE OF THIS PRODUCT.
(b) The warning statement shall be clearly legible and conspicuous on the product, its immediate container, its outer packaging, or other labeling in accordance with the requirements of 40 CFR part 82 and appear with such prominence and conspicuousness as to render it likely to be read and understood by consumers under normal conditions of purchase. This provision does not replace or relieve a person from any requirements imposed under 40 CFR part 82. (61 FR 20101, May 3, 1996)
8 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which "adequate directions for use" cannot be prepared, shall be exempt from section 502(1)(1) of the act if all the following conditions are met:
(a) The device is:
(1)(i) In the possession of a person, or his agents or employees, regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device; or
(ii) In the possession of a practitioner, such as physicians, dentists, and veterinarians, licensed by law to use or order the use of such device; and
(2) Is to be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice.
(b) The label of the device, other than surgical instruments, bears:
(1) The statement "Caution: Federal law restricts this device to sale by or on the order of a ", the blank to be filled with the word "physician”, "dentist", "veterinarian", or with the descriptive designation of any other practitioner licensed by the law of the State in which he practices to use or order the use of the device; and
(2) The method of its application or
(c) Labeling on or within the package from which the device is to be dispensed bears information for use, including indications, effects, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the device can use the device safely and for the purpose for which it is intended, including all purposes for which it is advertised or represented:
Provided, however, That such informa- 8801.116 Medical devices having comtion may be omitted from the dis- monly known directions. pensing package if, but only if, the ar
A device shall be exempt from secticle is a device for which directions,
tion 502(f)(1) of the act insofar as adehazards, warnings, and other informa
quate directions for common tion are commonly known to practi
thereof are known to the ordinary inditioners licensed by law to use the de
vidual. vice. Upon written request, stating reasonable grounds therefor, the Commis- 8801.119 In vitro diagnostic products. sioner will offer an opinion on a proposal to omit such information from
A product intended for use in the dithe dispensing package under this pro
agnosis of disease and which is an in viso.
vitro diagnostic product as defined in (d) Any labeling, as defined in section
$ 809.3(a) of this chapter shall be 201(m) of the act, whether or not it is
deemed to be in compliance with the on or within a package from which the
requirements of this section and secdevice is to be dispensed, distributed by
tion 502(1)(1) of the act if it meets the or on behalf of the manufacturer, pack- requirements of $809.10 of this chapter. er, or distributor of the device, that
8801.122 Medical devices furnishes or purports to furnish infor
essing, repacking, manufacmation for use of the device contains
turing. adequate information for such use, including indications, effects, routes,
A device intended for processing, remethods, and frequency and duration packing, or use in the manufacture of of administration and any relevant
another drug or device shall be exempt hazards, contraindications, side effects,
from section 502(f)(1) of the act if its and precautions, under which practi
label bears the statement “Caution: tioners licensed by law to employ the
For manufacturing, processing, or redevice can use the device safely and for packing". the purposes for which it is intended, including all purposes for which it is
$ 801.125 Medical devices for use in
teaching, law advertised or represented. This infor
search, and analysis. mation will not be required on called reminder-piece labeling which A device subject to $801.109 shall be calls attention to the name of the de- exempt from section 502(1)(1) of this act vice but does not include indications or if shipped or sold to, or in the possesother use information.
sion of, persons regularly and lawfully (e) All labeling, except labels and engaged in instruction in pharmacy, cartons, bearing information for use of chemistry, or medicine not involving the device also bears the date of the clinical use, or engaged in law enforceissuance or the date of the latest revi- ment, or in research not involving clinsion of such labeling.
ical use, or in chemical analysis, or
physical testing, and is to be used only $801.110 Retail exemption
for such instruction, law enforcement, scription devices.
research, analysis, or testing. A device subject to $801.109 shall be exempt at the time of delivery to the
$ 801.127 Medical devices; expiration
of exemptions. ultimate purchaser or user from section 502(1)(1) of the act if it is delivered (a) If a shipment or delivery, or any by a licensed practitioner in the course part thereof, of a device which is exof his professional practice or upon a empt under the regulations in this secprescription or other order lawfully tion is made to a person in whose posissued in the course of his professional session the article is not exempt, or is practice, with labeling bearing the made for any purpose other than those name and address of such licensed prac- specified, such exemption shall expire, titioner and the directions for use and with respect to such shipment or delivcautionary statements, if any, con- ery or part thereof, at the beginning of tained in such order.
that shipment or delivery. The causing