FEDERAL SECURITY AGENCY 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] 3681-3700 , ; ?- 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 Federal Security Agency, and include, where indicated, the results of investigations by the Agency, prior to the institution of the proceedings. Published by direction of the Federal Security Administrator. CHARLES W. CRAWFORD, Commissioner of Food and Drugs. WASHINGTON, D. C, August 7,1952. CONTENTS* Page Drugs actionable because of fail- ure to bear adequate direc- tions or warning statements 190 Drugs actionable because of con- tamination with filth 193 Drugs actionable because of devia- tion from official or own standards 194 Page Drugs and devices actionable because of false and mislead- ing claims. 196 Drugs for human use 196 Drugs for veterinary use 200 Index 201 *For presence of a habit-forming narcotic without warning statement, see Nos. 3681- 3683; omission of, or unsatisfactory, ingredients statements, Nos. 3682-3686, 3696; failure to bear a label containing an accurate statement of the quantity of the contents, Nos. 3681-3686; failure to bear a label containing the name and place of business of the manufacturer, packer, or distributor, Nos. 3683-3686. 189 213287-52- DRUGS ACTIONABLE BECAUSE OF FAILURE TO BEAR ADEQUATE DIRECTIONS OR WARNING STATEMENTS 3681.' MisBraqaing of Seconal Sodium capsules and methyltestosterone tablets. U. S. v^Norton Drug Stores, Inc., and Theodore Cibolski and Edward T. Eanaley. Pleas of guilty. Corporation fined $60, Theodore Cibolski fined $50, and Edward T. Kanaley fined $10, together with costs (F. D. C. No. 31262. Sample Nos. 70434-K, 70514-K, 70515r-K, 89784-K, 89787-K, 90017-K.) INFORMATION FILED: November 16, 195JL, District of Kansas, against Norton Drug Stores, Inc., Manhattan, Kans., and Theodore Cibolski, secretary of the corporation, and Edward T. Kanaley, an employee. INTERSTATE SHIPMENT: On or about February 23 and July 10, 1950, from the States of Missouri and New Jersey, of quantities of methyltestosterone tab- lets, and on or about July 13,1950, from the State of Missouri, of a quantity of Seconal Sodium capsules. ALLEGED VIOLATION: pn November 6, 9, 14, 20, and 21, 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 prescrip- tion, which acts resulted in the repackaged drugs being misbranded. The Norton Drug Stores, Inc., was charged with causing the acts of repacking and sale of the drugs involved in each of the six counts of the information; in addition, Theodore Cibolski, in each of five counts of the information, and Edward T. Kanaley, in one count, were charged with causing the acts charged in those counts. NATURE OF CHARGE: Misbranding, Section 502 (b) (2), the repackaged drugs failed to bear labels containing statements of the quantity of the contents; and, Section 502 (f) (1), the labeling of the repackaged drugs failed to bear adequate directions for use. Further misbranding, Section 502 (d), the Seconal Sodium capsules con- tained a chemical derivative of barbituric acid, which derivative has been found to be, and by regulations designated as, habit forming; and the re- packaged capsules bore no label containing the name, and quantity or pro- portion of such derivative and in juxtaposition therewith the statement "Warning-May be habit forming." DISPOSITION : March 7, 1952. Pleas of guilty having been entered, the court fined the corporation $60, Theodore Cibolski $50, and Edward T. Kanaley $10, together with costs.