Sec. 400.600 Drugs - Declaration of Quantity of Active Ingredient by Both Metric and
Apothecary Systems (CPG 7132.03)
BACKGROUND:
The USP and NF allow the simultaneous use of both the metric and apothecary systems to
declare the quantity of active ingredients present in drug product labeling. Prior to USP
XX and NF XV, the official compendia allowed the approximate equivalent of the exact
quantity to be enclosed in parenthesis; such as Quinidine Sulfate 200 mg. (3 grains).
On July 1, 1980 the USP XX and NF XV became official and requires that "Where
expressed in both the metric and apothecary systems, statements of quantity or strength in
the labeling of drug products shall utilize the exact equivalent." (See inside back
cover USP XX and NF XV). Therefore the above example would now have to be modified to read
Quinidine Sulfate 200 mg (3.086 grains).
POLICY:
USP and NF products shipped after 7/1/80 bearing a dual declaration will be considered
misbranded if the exact equivalents are not used. However, as a general rule we are not
prepared to initiate regulatory action of this violation alone. It may be included as a
502(g) charge only when other violations exist or it may serve as the basis for a Notice
of Adverse Findings letter.
Issued: 10/1/80