tion," followed by the number of minims or grains, as specified in the regulations; for instance, "laudanum (preparation of opium), 40 minims per ounce."

F. I. D. 57 (Mar. 13, 1907).

PHYSICIANS' PRESCRIPTIONS.1

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, morphine, 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 sulph. of morphine (each 24 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.

1 See United States v. Dr. J. L. Stephens Co., p. 466, post.

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.

F. I. D. 58 (Mar. 13, 1907).

THE LABELING OF PRODUCTS USED AS FOODS AND DRUGS AS WELL AS FOR TECHNICAL AND OTHER PURPOSES.1

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 cotton-seed 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 opin ion as to whether a sale or shipment of this oil (for lubricating purposes) under the ordinary trade brand of cotton-seed 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 cotton-seed 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 cotton-seed 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.

1See United States v. Lorick and Lowrance, p. 357, post; United States v. 300 Cans of Frozen Eggs, p. 444, post; and United States v. 13 Crates of Frozen Eggs, p. 669, post,

F. I. D. 59 (Mar. 13, 1907).

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 United States Pharmacopoeia or National Formulary.

F. I. D. 60 (Mar. 25, 1907).

MINOR BORDER IMPORTATIONS.

Inquiry has frequently been made regarding the application of regulation 33 (requiring a declaration to be attached to the invoice) to foods and drugs brought into the United States in small quantities by farmers living near the border. One correspondent says:

Farmers along the border are in the habit of occasionally bringing in, in their own teams, maple sugar in small quantities, also butter and like articles of food products of their own raising, and offering the same for entry at the different offices on the frontier. The main question is as to whether or not the affidavits and other proof required by the pure-food law shall be required in these instances of minor importations of this class of articles.

* *

Considering the nature of these importations it is held that regulation 33 does not apply to them and that they may be imported without the declaration. Such products are subject to inspection, however, and if found to be in violation of the law will be excluded.

F. I. D. 61 (Mar. 25, 1907).

COCOA BUTTER SUBSTITUTES.

A manufacturer writes:

We use in the preparation of chocolate sticks a guaranteed pure production of cocoanut oil. May this product be sold merely as confectionery, and not as chocolate sticks? If not, would it be satisfactory for us to mark the product as Chocolate sticks prepared with substitute butter?"

Regulation 22 prohibits the sale, or offer for sale, in interstate or foreign commerce or in the District of Columbia or in any Territory of the United States, of a food or drug product which bears no label whatever if said product be an imitation of or offered for sale under

the name of another article. It would clearly be a violation of the law to sell an article which was made in imitation of chocolate, even though it be sold under the general name of a confection. Such an article should be labeled in such manner as to correctly represent its true nature.

Regulation 25 (a) provides:

When a substance of a recognized quality commonly used in the preparation of a food or drug product is replaced by another substance not injurious or deleterious to health, the name of the substituted substance shall appear upon the label.

It is held that cocoa butter is the only fat that can properly be used in chocolate. The declaration of foreign fats merely as "substitute butter" is apparently not sufficient; the nature of the fat employed should be stated.

F. I. D. 62 (Mar. 25, 1907).

GUARANTY ON IMPORTED PRODUCTS.1

Many inquiries of the following type have been received by the department:

We will take it as a favor if you will advise us if (since our goods are all imported and so must pass the custom-house before being sold) the fact of their having passed the customs authorities and the Department of Agriculture examination is not in itself a guaranty that they conform with the pure-food laws as defined by the act of Congress approved June 30, 1906, entitled "An act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, liquors," etc. The department makes a systematic inspection of imported foods and drugs when they arrive at the custom-houses; and while such inspection does not include an examination of samples taken from every package of the aforesaid articles, it is sufficient to indicate that the article is suitable to enter the country and be sent into interstate commerce as long as it retains its identity in the unbroken package. If imported foods and drugs are taken from the original packages and repacked, they become subject to inspection as if of domestic origin, and the persons handling and selling said articles are not immune from prosecution in the event that a subsequent inspection discloses that all or any portion of said foods or drugs are adulterated or misbranded according to the provisions of said statute or the regulations made thereunder.

Only a wholesaler, jobber, manufacturer, or other party residing in the United States can give a guaranty within the meaning of said act. A foreign manufacturer or other foreign dealer can not give the guaranty prescribed in said law, nor can the agent of such foreign manufacturer or dealer give said guaranty unless such agent be a resident of the United States and unless he actually sells the goods covered by the guaranty.

The person who owns and sells imported goods can make a guaranty for the purpose aforesaid, though the goods may be shipped directly by the firm of whom the guarantor buys them to the customer of the guarantor.

1 See regulation 9, p. 19, ante, and F. I. D. 40, 70, 72, 83, 96, and 99 on guaranties; also F. I. D. 153, May 5, 1914, amending regulation 9.

40066-14- 4

F. I. D. 63 (Mar. 23, 1907).

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:

66

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 to 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 per cent 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. Eample: 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 Pharmacopoeia 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 per cent) shall be given in grains or minims, and if it is desired the metric equivalent may be given in addition.