(F. I. D. 63.)
USE OF THE WORD "COMPOUND" IN NAMES OF DRUG PRODUCTS.
Many inquiries are received concerning the use of the word "compound" in names of drug products. There seems to be a general impression that this word can be applied as a corrective to many misbranded products. The following extracts serve as examples:
You have on file our formula (active agents—croton oil and cascara), and we would ask
if it is possible to call the same "castor pill compound" and comply with the regulations?
This liniment has been in use for forty years. The ingredients, each separately and collectively, are sanitary and highly curative. The one ingredient after which it was named happens to be present in the least proportion. Can not the compound be called by the name "Compound Sassafras Cream"?
An eminent jurist writes:
I shall be glad to know the views entertained by your Department as to when a druggist
has satisfied this act by a label or printed matter which he puts on the package or bottle
in relation to a compound. Take, for example, the product put on the market as Cascarin
Compound, or Aloin Compound. I am impressed with the fact that such label must have
added a statement as to what the other ingredients of the compound are. This may not
mean, and probably does not mean, that the formula must be given or the exact proportions,
but a purchaser has the right to know what is in the compound in order to determine for
himself, or to receive proper advice, as to whether it is safe to be used.
In no case can a preparation be named after an ingredient or drug which is not present.
The word "compound" should not be used in connection with a name which in itself, or
together with representations and designs accompanying same, would be construed as a
form of misbranding under the act.
It is held that if a mixture of drugs is named after one or more but not all of the active medicinal constituents (not vehicle) present in a preparation, the word "compound" can be used in connection with the name, (a) provided the active constituent after which the product is named is present in an amount at least equal to that of any other active medicinal agent present. Example: If it is desired Lo make a mixture consisting of oil of sandalwood, balsam copaiba, and castor oil, and call this product "Oil of Sandalwood Compound," the oil of sandalwood should constitute at least 33-1/3 percent of the entire mixture. Or (b) provided the potent active constituent after which the product is named is present in sufficient amount to impart the preponderating medicinal effect. Example: If a product is named after the active constituent, strychnine, the strychnine or one of its salts should be present in sufficient amount to produce the preponderating medicinal effect of the preparation. Or (c) provided the complete quantitative formula, as outlined in the United States Pharmacopœia and National Formulary, be given on the principal label. A declaration of the complete quantitative formula, however, does not exempt the manufacturer or dealer from giving the information required by the act in the manner prescribed by the regulations. The ounce shall be the unit. The amounts of the ingredients present (excepting alcohol, which is to be stated in percent) shall be given in grains or minims, and if it is desired the metric equivalent may be given in addition.
James Wilson,
Secretary of Agriculture.
Washington, D. C., March 23, 1907.
