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] 4241-4260 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. GEO. P. LARRICK, Commissioner of Food and Drugs. WASHINGTON, D. C, December 9,1954. CONTENTS* Page Violative sales of prescription drugs.___, 230 Drugs actionable because of failure to bear adequate directions or warning statements 232 Drugs actionable because of devia- tion from official or own stand- ards 236 Page Drugs and devices actionable be- cause of false and misleading claims 238 Drugs for human use 238 Drug for veterinary use 241 Index 241 * For presence of a habit-forming narcotic without warning statement, see Nos. 4248, 4249 ; omission of, or unsatisfactory, ingredients statements, Nos. 42.47-4249, 4252 ; failure to bear a label containing an accurate statement of the quantity of the contents, Nos. 4247- 4249, 4252; failure to bear a label containing the name and place of business of the manufacturer, packer, or distributor, Nos, 4247, 4248, 4252. 320999-54 229 VIOLATIVE SALES OF PRESCRIPTION DRUGS 4241. Misbranding of Amytal Sodium capsules, Seconal Sodium capsules, and sulfadiazine tablets. U. S. v. Parke Drug Co., Samuel M. Larner, and Charles Levine. Pleas of guilty. Fine of $1,000 against company, $350 against Defendant Larner, and $250 against Defendant Levine. Each defendant also placed on probation for 1 year. (F. D. C. No. 34354. Sample Nos. 37336-L, 37702-L, 37706-L, 37708-L, 37891-L, 37895-L, 37900-L.) INFORMATION FILED: April 6, 1953, District of New Jersey, against the Parke Drug Co., a corporation, Asbury Park, N. I., Samuel M. Larner and Charles Levine, pharmacists for the corporation. NATURE OF CHARGE : On or about May 6,13, 20, 27, and 28,1952, while a number of Amytal Sodium capsules, Seconal Sodium capsules, and sulfadiazine tablets were being held for sale at the Parke Drug Co., after shipment in interstate commerce, various quantities of the drugs were dispensed upon requests for refills of prescriptions for such drugs, without obtaining authorization by the prescriber. The corporation was charged with causing the acts of dispensing involved in each of the 7 counts of the information, Defendant Larner was joined as a defendant in 3 counts, and Defendant Levine was joined as a de- fendant in the other 4 counts of the information. These acts of dispensing were contrary to the provisions of Section 503 (b) (1), and resulted in the dispensed drugs being misbranded while held for sale. DISPOSITION : November 16, 1953. Pleas of guilty having been entered by the defendants, the court fined the corporation $1,000, Defendant Larner $350, and Defendant Levine $250. The court also placed each defendant on probation for 1 year.