§ 212. What Drugs Deemed Adulterated. Section seven of the Food and Drugs Act provides "That for the purposes of this Act an article shall be deemed to be adulterated: "In case of drugs: "First. If when a drug is sold under or by a name recognized in the United States Pharmacopoeia or National Formulary, it differs from the standard of strength, quality or purity, as determined by the test laid down in the United States Pharmacopoeia or National Formulary official at the time of investigation: Provided, That no drug defined in the United States Pharmacopoeia or National Formulary shall be deemed to be adulterated under this provision if the standard of strength, quality or purity be plainly stated upon the bottle, box, or other container thereof although the standard may differ from that determined by the test laid down in the United States Pharmacopoeia or National Formulary. "Second. If its strength or purity fall below the professed standard or quality under which it is sold." This section fixes what is and what is not an adulterated PURE FOOD-18. 1 drug. We are not required to look elsewhere for a definition. If the drug stands the test laid down in either the United States Pharmacopoeia or National Formulary, official at the time of the investigation, then it is not adulterated; if it falls below that test, then it is adulterated, although according to some other test it is not. A sale of a drug that is not up to the test of either of these two authorities subjects the seller to the penalty prescribed by the statute for a sale of an adulterated drug. But the Pharmacopoeia or Formulary must state clearly the composition of the article; and if it merely gives a receipt how the article in question may be made, then it does not prescribe a test. It can not be shown that there is a commercial standard for the drug, as a defense, other than that of one or the other of these two authorities. If the article sold has no recognized standard of purity in these two authorities, then no offense is committed by selling an article of low quality but genuine.* Thus where marmalade was sold which contained 13 percent of glucose instead of cane or beet sugar; and there was evidence that for many years glucose had been used by some marmalade manufacturers, but not all, and that its use had a tendency to prevent mildew; and the Pharmacopoeia then in use did not prescribe the qualities of marmalade, it was held there could be no conviction of a sale of an adulterated article. But if a drug be defined by these two authorities, yet one of an inferior quality may be sold "if the standard of strength, quality or purity be plainly stated upon the bottle, box or other container thereof." The legend on the 1 White v. Bywater, 19 Q. B. Div. 582, 51 J. P. 821, 36 W. R. 280. 2 Hudson v. Bridge, 67 J. P. 186, 19 T. L. R. 369. 8 Dickins v. Randerson [1901], 1 K. B. 437, 65 J. P. 262, 70 L. J. K. B. 344, 84 L. T. 204, 19 Cox C. C. 643. But see Boots' Cash Chemists v. Cowling, 67 J. P. 195, 19 T. L. R. 370. 4 Hoyle v. Hitchman, 4 Q. B. Div. 233, 43 J. P. 431, 48 L. J. M. C. 97, 40 L. T. 252, 27 W. R. 487; Davidson v. McLeod, 42 J. P. 43, 5 Rettie (J. C.) 1, 3 Coup. 511; Morton v. Green, 8 Rettie (J. C.) 36, 4 Coup. 437. 5 Smith v. Wisden, 66 J. P. 150, 85 L. T. 760. label must be a plain one and truthful. But if the strength or purity of the drug fall below the professed standard or quality under which it is sold, then there is a sale of an adulterated drug. The first paragraph of the section above quoted relates to substances and mixtures of substances sold under or by a name recognized by the United States Pharmacopoeia or National Formulary; and the second relates to drugs generally whether named in these two authorities or not, and includes the so-called "patent" or proprietary medicines. Under this second paragraph the drug or medicine must be in strength and purity up to the professed standard or quality under which it is sold. Within the States the requirements of this section do not apply to prescriptions there compounded in which they are sold; but it does apply to prescriptions which are shipped out of the State and to drugs in original unbroken packages. If the patentee himself, or member of his household, or the physician himself, carries the package across a State line, and such package is not subject to sale, the package or prescription need not be labeled so as to conform with the law, because the transaction is not one of interstate commerce." In the District of Columbia and in the Territories the requirements of this section apply not only to drugs in the original unbroken packages, but also to prescriptions there compounded. § 213. Standard for Drugs. The regulations provide as follows: "(a) A drug bearing a name recognized in the United States Pharmacopoeia or National Formulary, without any further statement respecting its character, shall be required to conform in strength, quality and purity to the standards prescribed or indicated for a drug of the same name recognized in the United States Pharmacopoeia or National Formulary, official at the time."" Under this clause a sale is necessary to constitute the offense. F. I. D. 57. 1 Regulation 7. "If the Pharmacopoeia or Na tional Formulary says something is a drug, it is a drug under the meaning of the Act. Or if it comes under the other description [as defined by Section 6 of the Food and § 214. United States Pharmacopoeia and National Formulary. These are the two recognized authorities in this country on the standard of drugs. Editions from time to time of these works are issued; and it is to be observed that regulation seven requires the drug to be up to the standard prescribed by one or the other of these two works by the edition "official at the time" the drug is sold or offered for sale. If the drug at the time of the sale is then up to the standard prescribed by one of these authorities a subsequent edition requiring a higher standard can not turn what was an innocent act at the time of the sale into a criminal one. Of the National Formulary the Department of Agriculture has had this to say: "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 formulae collected in the appendix of the National Formulary are no longer designated as "N. F." preparations.' This shows that these formulae 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. Pharmacopoeia or National Formulary.” Drugs Act of 1906] of what a drug is, it is a drug, and so food also is described. There are no standards fixed in either case, for, if any substance or mixture is intended to be used for the cure, mitigation or prevention of disease of either man or other animals, it is nevertheless a drug whether it is recognized in the Pharmacopoeia or National Formulary or not." Judge Hollister, N. J. 823. 1 F. I. D. 59. Of course, the courts can not take judicial knowledge of the contents of those two standards; and it is not sufficient in a libel or indictment to aver generally that the drug drawn in question was below the standard prescribed by these two authorities. It should be averred what is the test these authorities require, and then an averment added that the article sold or offered for sale was below, stating in what particular, the test thus prescribed.2 ART. II.-SPECIFIC ARTICLES. SEC. 215. Assafoetida. 216. Belladonna root. 217. Blackberry cordial. 218. Camphor. 219. Cloves-Amboyna, powders. 220. Colocynth. 221. Gentian root, powdered. 222. Gum tragacanth. 223. Henbane, powdered. SEC. 223a. Kamola. 224. Laudanum. 225. Peroxide of Hydrogen. 226a. Sodic Aluminic Sulphate. scription given of the same in the Pharmacopoeia, it is usually necessary that the person should be supplied with the article prepared according to the formula given therein. Thus, if a person who asked for 'sweet spirits of nitre,' was supplied with an article not of the standard of the British Pharmacopoeia (cf. White v. Bywater, 19 Q. B. Div. 582, 51 J. P. 821, 36 W. R. 280) he might fairly consider himself as prejudiced by the transaction. But this is not the case when the British Pharmacopoeia states exactly what the constituent parts of the article should be. (See Hudson v. Bridge, 67 J. P. 186, 19 T. L. R. 369.). And it is possible that in some cases there may be a commercial standard for the article, differing |