"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."'1 § 401. Physicians' Prescriptions. "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 ten grains of sulphate of morphine (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. 1 F. I. D. 53. '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 habitue 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.” § 402. Products Used as Foods and Drugs and also for Technical and Other Purposes. "Frequent requests for information relative to the proper 1 F. I. D. 57. labeling of products bearing the names of food and drugs, but used also for technical and other purposes, are received. The following are typical: 'We 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 purpose, 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 opinion 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 undiscriminately 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 purpose, 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."" § 403. 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 connective 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 it 1 F. I. D. 58. self, 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 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 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 percent) shall be given in grains or minims, and if it is desired the metric equivalent may be given in addition.""1 § 404. Refilling Drug Bottles or Cartons. To remove the contents of a bottle or carton containing a drug and then refill it with the same kind of a drug, but not with that taken out, is to misbrand it, even if properly labeled when the original contents was put in it. A removal 1 F. I. D. 63. PURE FOOD-32. |