the United States Pharmacopoeia or National Formulary." Wood alcohol or denatured alcohol can not be used in hair tonics, liniments or other preparations for either internal or external use. The percentage of grain alcohol in foods need. not be stated.2

§ 396. Statement of Quantity or Proportion.

A drug "is misbranded in case it fails to bear a statement on the label of the quantity or proportion of any alcohol, morphine, opium, heroin, cocaine, alpha or beta eucaine, chloroform, cannabis indica, chloral hydrate or acetanilide, or any derivative or preparation of any such substances contained therein." "A statement of the maximum quantity or proportion of any such substances present" is sufficient, if "the maximum stated does not vary materially from the average quantity or proportion." "In declaring the quantity or proportion of any of the specified substances the names by which they are designated in the Act shall be used; and in declaring the quantity or proportion of derivatives of any of the specified substances, in addition to the trade name of the derivative, the name of the specified substance shall also be stated, so as to indicate clearly that the product is a derivative of the particular specified substance."" In case the actual quantity or proportion be stated it must be the average quantity or proportion, but a reasonable variation from the stated weight for individual packages is allowed if the variation is as often above as below the weight or volume stated. In the case of alcohol the average percentage by volume in the finished product must be given when stating the "quantity" or "proportion;" and in other ingredients required to be named on the label, the number of grains or minims per ounce or fluid ounce must be stated, "and also, if desired, the metric equivalents therefor, or milligrams per gram or per cubic centimeter, or grams or cubic centimeters per kilogram or per liter;" but if the maximum of quantity

1 Regulation 28.

2 F. I. D. 47.

1 Regulation 28.

2 Regulations 28 and 29.

or proportion be stated, then the article is not deemed misbranded. It is only in the finished product that the quantity or proportion of the substances therein must be named. If during the manufacture of the product substances are eliminated, they need not be stated. If the substance or a derivative of it is present in the finished product, only as a mere "trace,''as chemists term it, then it need not be stated on the label; but if present in any material quantity or proportion sufficient to enable its presence to be determined with certainty by analysis, then a statement of the amount must be placed on the label. If a medicine be put up in tablets, powder or capsules, then the quantity or proportion must be stated in grains or in minims per ounce (or as specified if the metric system be used), which is in each tablet, powder or capsule.

§ 397. 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. Pharmacopoeial 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?

'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:

3 As by Regulation 28.

4 Regulation 30.

5 It should be noted that the Department of Agriculture in the tak

'An article shall also be

ing of samples to be analyzed must always take them from finished products, and not from products in the course of manufacture.

.

.

.

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 formulae given in the U. S. Pharmacopoeia or National Formulary or formulae taken from any other source. The serial number, with or without the guarantee 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.""

§ 398. Drug Derivatives.

Regulation 29 defines what shall be considered as derivatives. Within the meaning of this Act a derivative is a substance which is so related to one of the specific substances "that it would be rightly regarded by recognized authorities in chemistry as obtained from the latter 'by actual or theoretical substitution,' and it is not indispensable that it should be actually produced therefrom as a matter of fact." The Board has the power, and has exercised it, to adopt a rule or regulation requiring the names of the specified substance to follow that of the derivative.1

§ 399. Substances in Drugs Required to be Named.

In labeling drugs, the label must bear a statement "of the quantity or proportion of any alcohol, morphine, opium, cocaine, heroin, alpha or beta eucaine, chloroform, cannabis indica, chloral hydrate or acetanilide, or any derivative or preparation of any such substances contained therein."" The

1 F. I. D. 54.

1 F. I. D. 112.

1 Section 8.

term "drug," as here used, includes all drug preparations and medicines, whether recognized by name in the United States Pharmacopoeia or National Formulary or not. This clause of the statute applies to all proprietary remedies or patent medicines containing any of the drugs named in the statute, as well as to all veterinary medicines and stock foods, and preparations having or purporting to have medicinal properties for either internal or external use in the treatment or prevention of disease either in man or beast. Bitters is an example of this kind. In the Territories and District of Columbia this requirement applies to physicians' prescriptions, but it does not apply to alcohol used in any article of food, as flavoring extracts. It is only when the drug contains one of the substances above stated in the quotation that it is necessary to state its ingredients; if it contains an ingredient not thus enumerated it need not be stated on the label unless it be a derivative. These statutory names should be used on the labels, and not substitutes. The Department has given the following opinion on this question:

3

5

"Many inquiries are received as to the method of stating the quantity or proportion of preparations (containing opium, morphine, 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 of 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 article 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?'

2 See F. I. D. 90.

3 F. I. D. 85.

4 F. I. D. 57.

5 F. I. D. 47.

6 F. I. D. 54; F. I. D. 55; F. I. D. 56; United States v. American Druggists' Syndicate, 186 Fed. 387.

"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.""

§ 400. Formula on Label of Drugs.

"Many inquiries are received relative to the necessity of giving the formula of medicinal remedies on the label. following is typical:

The

'I should like to know if it will be necessary for me to state on a label the name of the products from which I prepare my proprietary medicine in order to conform with the Pure Food and Drugs Act. If I do this it will prohibit me from manufacturing and selling a remedy which is a secret of my own; and anyone buying it could, from the label, tell what ingredients were used in its preparation and make his own supply of this medicine. How does the United States Government expect to protect those who have secret medicinal preparations they wish to sell at a profit? If the Pure Food Commission desires, I will send them a sample bottle of my medicine for their inspection and approval.'

"The Food and Drugs Act, June 30, 1906, does not require the formula of drug products to be given on the label, but requires only that the quantity or proportion of the ingredients enumerated in the law, and derivatives and preparations 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.

7 F. I. D. 55.

Peroxide contained in a substance need not be named on the

label. United States v. American Druggists' Syndicate, 186 Fed. 387.