FOOD AND DRUG ADMINISTRATION NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD, DRUG, AND COSMETIC ACT [Given pursuant to section 705 of the Food, Drug, and Cosmetic Act] 5321-5340 DRUGS AND DEVICES The cases reported herewith were instituted in the United States district courts by United States attorneys, acting upon reports submitted by the De- partment of Health, Education, and Welfare. They involve drugs and devices which were adulterated or misbranded within the meaning of the Act when introduced into and while in interstate commerce or while held for sale after shipment in interstate commerce. These cases involve (1) seizure proceedings which were terminated with the entry of default or consent decrees of condem- nation and (2) criminal proceedings terminated with a plea of guilty. The seizure proceedings are civil actions taken against the goads alleged to be in violation, and the criminal proceedings are against the firms or individuals charged to be responsible for violations. Published by direction of the Secretary of Health, Education, and Welfare. GEO. P. LAEEICK, Commissioner of Food and Drugs. WASHINGTON, D. C., December 12, 1958. Page Drugs in violation of prescription labeling requirements 248 Drugs and devices actionable be- cause of failure to bear ade- quate directions or warning statements 249 Presence of a habits-forming narcotic without warning statement?254 Drug actionable because of contam- j ination with filth 255 487698-58 CONTENTS Page Drugs actionable because of devia- tion from official or own stand- ards 255 Drugs and devices actionable be- cause of false and misleading claims 258 Drugs for human use 258 Drug for veterinary use 260 Index 261 247 SECTIONS OF FEDERAL FOOD, DRUG, AND COSMETIC ACT INVOLVED IN VIOLATIONS /"" REPORTED IN D. D. N. J. NOS. 5321-5349 Adulteration, Section 501 (a) (2), the article had been held under insanitary conditions; Section 501 (b), the article purported to be and was represented as a drug, the name of which is recognized in an official compendium (National Formulary or United States Pharmacopeia), and its strength differed from, or its quality fell below, the standard set forth in such compendium; Section 501 (c), the article was not subject to the provisions of Section 501 (b), and its strength differed from, or its purity or quality fell below, that which it purported or was represented to possess. Misbranding, Section 502 (a), the labeling of the article was false and mislead- ing; Section 502 (d), the article contained a chemical derivative of barbituric acid, and its label failed to bear the name, and quantity or proportion of such derivative and in juxtaposition therewith the statement "Warning-May be habit forming"; Section 502 (f) (1), the labeling of the article failed to bear adequate directions for use; Section 502 (f) (2), the labeling of the article failed to bear adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner .and form, as are necessary for the protection of users; Section 503 (b) (4), the label of the article bore the statement "Caution: Federal law prohibits dispensing without prescription," and it was a drug to which Section 503 (b) (1) did not apply. DRUGS IN VIOLATION OF PRESCRIPTION LABELING REQUIREMENTS 5321. Glandular preparations. (F. D. C. No. 36806. S. Nos. 88-808/21 L.) ( QUANTITY: 32 boxes, 6 cartoned 1-cc. ampuls each, of corpora lutea soluble extract; 11 btls., 100 5-grain Emplets each, and 19 btls., 50 5-grain tablets each, of corpora lutea desiccated; 30 btls., 100 5-grain Emplets each, of ovarian residue; 28 1-oz. btls. of ovarian substance desiccated; 15 boxes, 12 cartoned 1-cc. ampuls each, of ovarian substance soluble extract; 111 btls., 100 5-grain Emplets each, and 44 btls., 100 5-grain tablets each, of ovarian sub- stance desiccated; 27 btls., 100 ?o-grain Emplets each, and 16 btls., 100 Ho-grain tablets each, of parathyroid gland desiccated; 4 1-oz. btls. of pituitary body anterior lobe desiccated and 23 btls., 100 2?-grain Emplets each, 42 btls., 100 5-grain Emplets each, 9 btls., 100 2?-grain tablets each, and 20 btls., 100 5-grain tablets each, of pituitary body anterior lobe desiccated; 10 1-oz. btls., 40 btls., 100 1-grain Emplets each, and 13 btls., 100 1-grain tablets each, of pituitary body whole gland desiccated, at Chicago, 111. SHIPPED: Between 8-13-53 and 3-17-54, from Detroit, Mich., by Parke, Davis &Co. TiTBiET.rcp: 5-27-54, N. Dist. 111. CHARGE: (502) (f) (1)-the labeling of the articles, when shipped, failed to bear adequate directions for use; and 503 (b) (4)-all articles, except the 32- box lot of corpora lutea soluble extract and the 15-box lot of ovarian substance soluble extract, bore on their labels prior to dispensing the statement "Caution: Federal law prohibits dispensing without prescription," and such articles were drugs to which 503 (b) (1) did not apply. DISPOSITION : 4-23-57. Upon the representation of the claimant, Parke, Davis & Co., that the intrinsic value of the article was negligible, and with the consent! of the claimant and the Government that a decree might be entered pursuant - 249 to the provisions of the Federal Food, Drug, and Cosmetic Act without adjudi- cation as to any issue of fact or law, the court entered an order directing that the article be turned over to the United States Department of Health, Edu- cation, and Welfare, pursuant to the provisions of such Act. DRUGS AND DEVICES ACTIONABLE BECAUSE OF FAILURE TO BEAR ADEQUATE DIRECTIONS OR WARNING STATEMENTS*