[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: 21CFR201.51]
[Page 20-21]
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 B Labeling Requirements for Prescription Drugs and/or Insulin
Sec. 201.51 Declaration of net quantity of contents.
(a) The label of a prescription or insulin-containing 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 of numerical count and weight or measure. The
statement of quantity of drugs in tablet, capsule, ampule, or other unit
dosage form 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, semi-solid, or viscous, or in terms of
fluid measure if the drug is liquid. When the drug quantity statement is
in terms of the numerical count of the drug units, it shall be augmented
to give the weight or measure of the drug units or the quantity of each
active ingredient in each drug unit or, when quantity does not
accurately reflect drug potency, a statement of the drug potency.
(b) Statements of weight of the contents shall in the case of
prescription drugs be expressed in terms of avoirdupois pound, ounce,
and grain or of kilogram, gram, and subdivisions thereof. A statement of
liquid measure of the contents shall in the case of prescription drugs
be expressed in terms of the U.S. gallon of 231 cubic inches and quart,
pint, fluid-ounce, and fluid-dram subdivisions thereof, or of the liter
and milliliter, or cubic centimeter, and shall express the volume at 68
[deg]F. (20 [deg]C.). A statement of the liquid measure of the contents
in the case of insulin-containing drugs shall be expressed in terms of
the liter and milliliter, or cubic centimeter, and shall express the
volume at 68 [deg]F. (20 [deg]C.).
(c) The declaration shall contain only such fractions as are
generally used in expressing the quantity of the drug. A common fraction
shall be reduced to its lowest terms; a decimal fraction shall not be
carried out to more than three places, except in the case of a statement
of the quantity of an active ingredient in a unit of a drug.
(d) The declaration shall appear as a distinct item on the label
and, in the case of large volume parenterals, may be embossed on the
glass.
(e) The declaration shall accurately reveal the quantity of drug in
the package exclusive of wrappers and other material packed therewith.
(f) A statement of the quantity of a prescription or insulin-
containing drug in terms of weight or measure applicable to such drug,
under the provisions of paragraph (a) of this section, shall express
with prominence and conspicuousness the number of the largest whole
unit, as specified in paragraph (b) of this section, that are contained
in the package. Any remainder shall be expressed in terms of common or
decimal fractions of such unit or in terms of the next smaller whole
unit and common or decimal fractions thereof.
(g) The declaration of net quantity of contents shall express an
accurate statement of the quantity of contents of the package.
Reasonable variations
[[Page 21]]
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. In the case of a liquid drug in ampules
or vials, intended for injection, the declaration shall be considered to
express the minimum quantity and the variation above the stated measure
shall comply with the excess volume prescribed by the National Formulary
or the U.S. Pharmacopeia for filling of ampules. In the case of a solid
drug in ampules or vials, the declaration shall be considered to express
the accurate net weight. Variations shall comply with the limitations
provided in the U.S. Pharmacopeia or the National Formulary.
(h) 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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