[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.51]

[Page 21-22]
 
                        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

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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 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.