U. S. Department of Health, Education, and Welfare 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] 3901-3920 DRUGS AND DEVICES The cases reported herewith were instituted in the United States district* courts by the United States attorneys, acting upon reports submitted by the Department of Health, Education, and Welfare, and include, where indicated, the results of investigations by the Department, prior to the institution of the pro- ceedings. Published by direction of the Secretary of Health, Education, and Welfare. CHARLES W. CRAWFORD, Commissioner of Food and Drugs. WASHINGTON, D. C, July 1, 1958. Page Drugs actionable because of failure to bear adequate directions or warning statements 398 Drugs actionable because of devia- tion from official or own stand- ards 404 CONTENTS* Page Drugs and devices actionable be- cause of false and misleading claims 408 Index 413 ?For presence of a habit-forming narcotic without warning statement, see No. 3901; omission of, or unsatisfactory, ingredients statements, Nos. 3901, 3912 ; failure to bear a label containing an accurate statement of the quantity of the contents, Nos. 3901, 3912; failure to bear a label containing the came and place of business of the manufacturer, packer, or distributor, Nos. 3901, 3912. 397 257492-53 FOOD, DRUG, AND COSMETIC ACT [D. D. N. J. DRUGS ACTIONABLE BECAUSE OF FAILURE TO BEAR ADEQUATE f ?? DIRECTIONS OR WARNING STATEMENTS f-M 3901. Misbranding of sulfadiazine tablets, Nembutal Sodium capsules, Tuinal capsules, diethylstilbestrol perles, and Dexedrine Sulfate tablets. U. S. v. Henry R. Namour and John C. Wicks. Pleas of nolo-contendere. Imposition of sentence suspended and defendants placed on probation for 1 year. (F. D. C. No. 30025. Sample Nos. 76416-K, 76417-K, 77107-K to 77109-K, incl., 77112-K, 77131-K, 77132-K.) INFORMATION FILED : September 11, 1951, Eastern District of Arkansas, against Henry R. Namour, a partner in the partnership trading as Henry's Drug" Store, Helena, Ark., and John C. Wicks, pharmacist for the firm. INTERSTATE SHIPMENT : From the States of Missouri, Tennessee, Indiana, and Pennsylvania, into the State of Arkansas, of quantities of sulfadiazine tablets, Nembutal Sodium capsules, Tuinal capsules, diethylstilbestrol perles, and Dexedrine Sulfate tablets. ALLEGED VIOLATION : On or about March 7, 8, and 9, 1950, while the drugs were being held for sale after shipment in interstate commerce, various quantities of the drugs were repacked and sold without a physician's prescription, which acts resulted in the repackaged drugs being misbranded. John C. Wicks was charged with the violations involved in the first 5 counts of the information, and Henry R. Namour was charged with the violations involved in the remaining 3 counts. NATURE OF CHARGE : Misbranding, Sections 502 (b) (1) and (2), the repackaged drugs bore no labels containing accurate statements of the quantity of the con- tents and, with the exception of 1 lot of Tuinal capsules and the diethylstil- bestrol perles, failed to bear labels containing the name and place of business of the manufacturer, packer, or distributor; and, Section 502 (f) (1), the labeling of the repackaged drugs bore no directions for use. Further misbranding, Section 502 (d), the Nembutal Sodium capsules and the Tuinal capsules contained chemical derivatives of barbituric acid, which derivatives have been found to be, and by regulations designated as, habit forming; and the label of the repackaged capsules failed to bear the name, and quantity or proportion of such derivatives and in juxtaposition therewith the statement "Warning-May be habit forming." Further misbranding, Section 502 (e) (1), the repackaged Dexedrine Sulfate tablets bore no label containing the common or usual name of the drug; and, Section 502 (f) (2), the labeling of the repackaged sulfadiazine tablets bore no warnings against use in those pathological conditions where their use may be dangerous to health, and against unsafe dosage and methods and duration of administration. DISPOSITION : September 18,1951. Pleas of nolo contendere having been entered, the court suspended the imposition of sentence and placed the defendants on probation for 1 year.