FEDERAL SECURITY AGENCY " D#S'T ~~ -- ? ? ? ---- FOOD AND DRUG ADMINISTRATION X^L^8* ^ * NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD, DRUG, AND COSMETIC ACT [Given pursuant to section 705 of the Food, Drug, and Cosmetic ActJ 3241-3260 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 investiga- tions of the Agency, prior to the institution of the proceedings. Published by direction of the Federal Security Administrator. PAXIL B. DUNBAK, Commissioner of Food arid Drugs. WASHINGTON, D. C, January 25, 1951. CONTENTS* Page Drugs actionable because of failure to bear adequate directions or - warning statements??224 Drug actionable because of con- . tamination with filth .228 Drugs and devices actionable be- cause of deviation from official or own standards. -,?-4-?'229 Page Drugs and devices actionable be- cause of false and misleading claims ?_; __^_ ,231 Drugs for human use -,..-- 231 Drugs for veterinary use. 234 Index.._______? _-_.._'_'_... 235" *For presence of a habit-forming narcotic without warning statement, see Nos. 3241, 3245, 3246; omission of, or unsatisfactory, ingredients statements, Nos. 3242, 3243, 3246, 3258;, failure to bear a label containing an accurate statement of the .quantity of the-con- tents, Nos. 3241-3248; failure to bear a label containing the name and place of business of the manufacturer, packer, or distributor, Nos. 3241-3245, 3248. 223 922417-51 ?BUGS ACTIONABLE BECAUSE OF FAILURE TO BEAR ADEQUATE \ DIRECTIONS OR WARNING STATEMENTS 3241. Misbranding of sulfathiazole lozenges, Dexedrine Sulfate tablets, and Tuinal capsules. U S. v. Elias A. Doerr (Doerr's Drug Store), and Arthur R. Morgan. Pleas of guilty. Each defendant fined $100 and placed on probation for 1 year. (F. D. C. No. 28121. Sample Nos. 61307-K, 61312-K, 61315-K, 61316-K.) INFORMATION FILED: January 31, 1950, Eastern District of Illinois, against Elias A. Doerr, trading as Doerr's Drug Store, Murphysboro, 111., and Arthur R. Morgan, a pharmacist. INTEBSTATE SHIPMENT : On or about December 10, 1947, and April 21 and May 27, 1949, from the States of Indiana and Missouri into the State of Illinois, of quantities of sulfathiazole lozenges, Dexedrine Sulfate tallets, and Tuinal capsules. ALLEGED VIOLATION: On or about July 22 and 27, 1949, while the drugs were being held for sale after shipment in interstate commerce, the defendants, Elias* A. Doerr and Arthur R. Morgan, caused a number of sulfathiazole loz- enges and a number of Dexedrine Sulfate taolets to be repackaged and sold with- out a prescription, and on July 28, 1949, defendant Elias A. Doerr caused a number of sulfathiazole lozenges and a number of Tuinal capsules to be re- packaged and sold without a prescription, which acts of the defendants re- sulted in the drugs being misbranded. NATURE OF CHARGE: Misbranding, Section 502 (b) (1), one sale of the re-' packaged sulfathiazole lozenges failed to bear a label containing the name and place of business of the manufacturer, packer, or distributor; and, Section 502 (b) (2), all of the repackaged drugs failed to bear labels containing an accurate statement of the quantity of the contents. Further misbranding, Section 502 (d), the Tuinal capsules contained deriva- tives of barbituric acid, which derivatives had been found to be, and by regula- tions designated as, habit forming; and when repackaged, the Tuinal capsules failed to bear a label containing the name, and quantity or proportion of such de- rivatives and in Juxtaposition therewith the statement "Warning-May be habit forming." Further misbranding, Section 502 (f) (1), all of the repackaged drugs failed to bear labeling containing directions for use; and, Section 502 (f) (2), the repackaged sulfathiazole lozenges bore no labeling containing 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 25, 1950. Pleas of guilty having been entered, the court fined each defendant $100 and placed each on probation for 1 year.