enumerated in the law, and derivatives and preparation of same (Regulation 28), shall be clearly set forth on the label or labels of all preparations used for the treatment or prevention of disease, either internally or externally, for man or other animals. This includes sample packages as well as regular trade packages.
The question is also frequently asked whether a medicinal preparation would be exempt from the operation of the law if the formula were given on the label. The formula on the label is very desirable, but this information is not required by the law. The act forbids the use of any statement, design, or device in connection with any drug product which is false or misleading in any particular. A defect of this kind would not be corrected by giving the formula on the label. If the formula is given, it must be the correct and complete formula. It is held that, in addition to those substances required by the act to be named, if only a part of the active medicinal agents used in the manufacture of a drug product are set forth on the label, such a procedure is misleading and therefore forbidden by the law. All drug products and their labels must conform to the act, whether the formula is or is not given on the label.
James Wilson,
Secretary of Agriculture.
Washington, D. C., January 28, 1907.
F. I. D. 54-59. Issued March 23, 1907.
UNITED STATES DEPARTMENT OF AGRICULTURE,
BUREAU OF CHEMISTRY,
H. W. Wiley, Chief of Bureau.
FOOD INSPECTION DECISIONS 54-59.
54. Declaration of the quantity or proportion of alcohol present in drug products.
55. Method of stating quantity or proportion of preparations (containing
opium, morphin, etc.) used in manufacturing other preparations.
56. Names to be employed in declaring the amount of the ingredients as
required by the law. 57. Physicians' prescriptions: The status of packages
compounded according to physicians' prescriptions and entering into
interstate commerce. 58. The labeling of products used as food and
drugs as well as for technical and other purposes. 59. National Formulary
appendix.
(F. I. D. 54.)
DECLARATION OF THE QUANTITY OR PROPORTION OF ALCOHOL PRESENT IN DRUG PRODUCTS.
The question of stating the percentage of alcohol present in drug products has caused a multitude of inquiries. The following questions along this line serve as examples:
Is it necessary to give the amount of alcohol present in U. S. Pharmacopœial or National
Formulary products? It seems to me that such a requirement is absurd, and not contemplated
within the spirit of the act. None of them are patent medicines. Will I be compelled
to tell how much alcohol is present in such goods?
