Food Inspection Decisions 54-59

. Declaration of the quantity or proportion of alcohol present in drug products. . Method of stating quantity or proportion of preparations (containing opium, morphin, etc.) used in manufacturing other preparations. . Names to be employed in declaring the amount of the ingredients as required by the law. . Physicians’ prescriptions: The status of packages compounded according to physicians’ prescriptions and entering into interstate commerce. . The labeling of products used as food and drugs as well as for technical and other purposes. . 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?

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 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.

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 , 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.

(F. I. D. 56.) Names to Be Employed in Declaring the Amount of the Ingredients as Required by the Law.

Many inquiries are coming to this Department relative to the names that may be employed in declaring the quantity or proportion of the ingredients, as required by Congress.

The following are representative:

The word “alcohol” has received so much unfavorable notoriety during the last few years that we hesitate to place it upon our labels. Could we not employ some other words in place of it, such as “cologne spirits,” “spirits of wine,” “pure grain alcohol,” etc.?

Would it be satisfactory for us to use “Phenylacetamid,” or the following formula, C6H5(CH3CO), for the chemical acetanilid?

One of our preparations contains trichlorethidene ethyl alcoholate, which would undoubtedly under the law be considered a derivative of chloral hydrate. Will it be satisfactory for us to use this name on our trade packages in giving the amount of this chemical present in the product?

In the manufacture of some of our products we use opium. It would, however, be a financial loss to state this fact on the label. Could we not say this preparation contains 20 grains of the concentrated extract of the Papaver somniferum to the fluid ounce?

Dover’s powder is mentioned in the regulations as one of the preparations of opium. It would seem sufficient at first glance that Dover’s powder as a preparation, if mentioned on the label, would be all that could be required as to opium.

One of the objects of the law is to inform the consumer of the presence of certain drugs in medicines, and the above terms do not give the average person any idea as to the presence or absence of such drugs. In enumerating the ingredients, the quantity or proportion of which is required to be given upon the principal label of any medicinal preparation in which such ingredients may be present, the act uses only common names, and the permission to use any but such common names for any ingredients required to be declared upon the label is neither expressed nor implied in any part of the law.

The term used for acetanilid is “acetanilid” and not phenylacetamid. No reference is made to the use of the chemical formula in designating the presence of chemicals. The words “chloral hydrate” appear in the act, but not the chemical name trichlorethidene glycol. It can readily be seen that if the act were not closely adhered to in this connection there would soon be such a confusion and multiplicity of names and phrases that one of the objects of the act would be defeated.

The names to be employed in stating the quantity or proportion of the ingredients required by the act to appear on the label of all medicinal preparations containing same are—

First. Those used in the law for the articles enumerated; example, “alcohol,” not “spiritus rectificatus.”

Second. In the case of derivatives: (a) The name of the parent substance used in the act should constitute part of the name; example, “chloral acetone,” not “trichlorethidene dimethyl ketone.” (b) The trade-name, accompanied in parentheses by the name of the parent substance; example, “dionin (morphin derivative).”

Third. Names of preparations containing the name of some ingredient used in the act. In such cases the name used in the act should constitute the first portion of the name of the preparation. (See F. I. D. 55.)

Fourth. Common names (such as laudanum, Dover’s powder, etc.) of preparations containing an ingredient enumerated in the law, provided such name or names are accompanied in parentheses by some such phrase as “preparation of opium” or “opium preparation,” followed by the number of minims or grains, as specified in the regulations; for instance, “laudanum (preparation of opium), 40 minims per ounce.”

James Wilson,
Secretary of Agriculture.

Washington, D. C., March 13, 1907.

(F. I. D. 57.) Physicians’ Prescriptions. The Status of Packages Compounded According to Physicians’ Prescriptions and Entering into Interstate Commerce.

Packages resulting from the compounding of physicians’ prescriptions under the food and drugs act are the subject of many queries, of which the following are representative:

If a druggist compounds a physician’s prescription and sends it into an adjoining State, will it be necessary to state upon the label the amount of alcohol, morphin, etc., that may be present?

Supposing a regularly licensed practicing physician has patients located in various States of the Union and supplies medicines to them through the mails, by express, and otherwise, do such packages come under the provisions of the law, and, if so, can the required information be given in pen and ink on the label?

We treat drug addictions on a very gradual tonic treatment reduction plan. For instance, if John Doe writes for information as to the home treatment for his addiction, I send him a symptom blank which contains, among other questions, an inquiry as to the kind of drug he uses, how he uses it, the length of time he has used it, etc. In addition to giving me a complete history of his case, he states he is using 10 grains of sulf. of morphin (each twenty-four hours), hypodermically or internally, as the case may be. In prescribing in his case I immediately put him on just one-half of the amount he reports as his daily allowance, combining same with a bitter tonic.

It is necessary for the reduction in drug cases to be made without the patient’s knowledge. It is, of course, understood by all physicians that you can not trust a drug habitué to properly make his own reductions, for, as a matter of fact, if he knew to what extent I was reducing his daily allowance of opiates, he would imagine the reduction too rapid, he would get frightened, and would take to his former drug for relief. Treatment prepared in this way I do not think would come under the head of a proprietary preparation or a patent medicine, as I prescribe the contents of each bottle to meet the requirements of each individual patient. All instructions as to the conduct of treatment and the use of auxiliary remedies are given by letter; consequently there are no printed labels or cartons containing any claims concerning the efficacy of this treatment.

I would be pleased to have you inform me whether in your opinion I would be violating the pure-food law in any manner, shape, or form should I continue to label my preparations as I am now doing, and in having them prepared in ———— and forwarded direct to my patients in this and other States.

If a package compounded according to a physician’s prescription be shipped, sent, or transported from any State or Territory or the District of Columbia to another State or Territory or the District of Columbia by a compounder, druggist, physician, or their agents, by mail, express, freight, or otherwise, the label upon such package is required to bear the information called for by Congress. If, however, the patient himself, or a member of his household, or the physician himself carries such package across a State line, and such package is not subject to sale, it is held that such package need not be marked so as to conform with the law, because such a transaction is not considered one of interstate commerce.

The package may be marked so as to comply with the act by either stamp, pen and ink, or typewriter, provided all such written matter is distinctly legible and on the principal label, as prescribed in Regulation 17.

James Wilson,
Secretary of Agriculture.

Washington, D. C., March 13, 1907.

(F. I. D. 58.) the Labeling of Products Used as Foods and Drugs as Well as for Technical and Other Purposes.

Frequent requests for information relative to the proper labeling of products bearing the names of foods and drugs, but used also for technical and other purposes, are received. The following are typical:

We will kindly ask you to advise us in regard to the new law that governs the line of oils. We manufacture a compound product, so-called “turpentine,” which contains pure turpentine and a very fine petroleum product. It is used in most branches where pure turpentine is used, with the exception of medicinal purposes, for which we do not sell it.

We understand that if we were to sell any cottonseed oil so branded as to indicate that it was intended to be used as a food, as, for example, under the brand “Blank Salad Oil,” it would be necessary to observe the requirements of the law referred to; but we are in doubt and would be glad to have your opinion as to whether a sale or shipment of this oil (for lubricating purposes) under the ordinary trade-brand of cottonseed oil, and without anything to indicate that it was of a quality suitable for use as a salad oil, would subject us to the provisions of the act.

During personal interviews the question of marking chemical reagents has also been discussed.

Products used in the arts and for technical purposes are not subject to the food and drugs act. It is, however, a well-recognized fact that many articles are used indiscriminately for food, medicinal, and technical purposes. It is also well known that some products employed for technical purposes are adulterated or misbranded within the meaning of this act. Inasmuch as it is impossible to follow such products into consumption in order to determine to what use they are finally put, it is desirable that an article sold under a name commonly applied to such article for food, drug, and technical purposes be so labeled as to avoid possible mistakes. The ordinary name of a pure and normal product, whether sold for food, drug, technical, or other purposes, is all that is necessary. Pure cottonseed oil or turpentine may be sold without any restrictions whatever, whether such article is sold for food, medicinal, or technical purposes, but it is suggested that a cottonseed oil intended for lubricating purposes, or a so-called turpentine consisting of a mixture of turpentine and petroleum oils, used by the paint trade, be plainly marked so as to indicate that they are not to be employed for food or medicinal purposes. Such phrases as the following may be used: “Not for Food Purposes,” “Not for Medicinal Use,” or for “Technical Purposes Only,” or “For Lubricating Purposes,” etc.

In order to avoid complication it is suggested that chemical reagents sold as such be marked with such phrases as the following: “For Analytical Purposes,” or “Chemical Reagent,” etc.

James Wilson,
Secretary of Agriculture.

Washington, D. C., March 13, 1907.

(F. I. D. 59.) National Formulary Appendix.

The National Formulary is one of the standards recognized under the law. The question has been asked a number of times whether the appendix of this authority would be construed as part and parcel of the book itself. On page iv of the preface it is distinctly stated that the formulæ collected in the appendix of the National Formulary are “no longer designated as ‘N. F.’ preparations.” This shows that these formulæ are not integral parts of the book under the law, which covers only those products of the National Formulary recognized as such by this authority. By this it is understood that if a drug product is sold under a name contained in the appendix of the National Formulary, it will not be necessary for such product either to conform to the standard indicated by the formula or to declare upon the label its own standard strength, quality, and purity if a different formula is employed in its manufacture. Such articles are, however, subject to the law in every other respect, as is the case of other medicinal products not recognized by the U. S. Pharmacopœia or National Formulary.

James Wilson,
Secretary of Agriculture.

Washington, D. C., March 13, 1907.