If we apply for and obtain a serial number, must we in addition to putting this number on our labels state the percent of alcohol?
Will it be necessary to give the percent of alcohol present in such products as ether, chloroform, collodion, spirit of nitrous ether, and similar preparations?
The law is specific on the subject of declaring the amount of alcohol present in medicinal
agents, as can readily be seen from the following language: "An article shall also
be deemed misbranded . . . if the package fail to bear a statement on the label of
the quantity or proportion of any alcohol . . . contained therein. No medicinal
preparations are exempt, whether they are made according to formulæ given in the U. S.
Pharmacopœia or National Formulary or formulæ taken from any other source. The
serial number, with or without the gaurantee legend, does not exempt a preparation from
this requirement. The law does not make any statement as to the amount of alcohol
that may or may not be employed. It requires, however, that whatever amount be present
shall be set forth on the label. The percentage of alcohol given on the label should
be the percentage of absolute alcohol by volume contained in the finished product. The
manner in which it should be printed is shown in F. I. D. 52.
James Wilson,
Secretary of Agriculture.
Washington, D. C., March 13, 1907.
(F. I. D. 55.)
METHOD OF STATING QUANTITY OR PROPORTION OF PREPARATIONS (CONTAINING OPIUM, MORPHIN, ETC.) USED IN MANUFACTURING OTHER PREPARATIONS.
Many inquiries are received as to the method of stating the quantity or proportion of preparations (containing opium, morphin, etc.) used in the manufacture of other preparations. Of these the following are typical:
If the label on the bottle were to bear the words "Tincture of Opium," I reason that
as this is a definite preparation, constituting a preparation of opium, and so definite as
to its composition that to any intelligent person it expresses definitely all that it is desirable
to express, the use of this title alone should be sufficient. I feel that as a preparation it is
distinct from opium, and if this particular tincture is used in the manufacture of a preparation
the mention of it alone should be sufficient.
Where extract or tincture of cannabis indica, or extract of opium, is employed in making other drug products, would it not be complying with the law if the use of such articles be clearly indicated on the label as prescribed by the law, or is it necessary to give the actual amounts of the drugs themselves represented by these preparations?
Names of drug products bearing any of the names of the ingredients enumerated in
the act are construed as representing "preparations" within the meaning of the act;
and if the same are clearly declared upon the label as required by Regulations 17 and 30,
it will not be necessary to give the actual amount of the primary drugs used or represented
by such article. It is desirable, however, that the word or words used in the law shall
constitute the first part of the name of the product. For example: "Opium, Tincture of;"
"Cannabis Indica, Extract of," followed by the amount of tincture or extract used.
James Wilson,
Secretary of Agriculture.
Washington, D. C., March 13, 1907.
