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 ActI 3701-3720 '!--- -- 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. Published by direction of the Federal Security Administrator. CHABXES W. CRAWFORD, Commissioner of Food and Drugs. WASHINGTON, D. C, September 24, 1952. CONTENTS* Page Drugs actionable because of failure to bear adequate directions or warning statements 204 Drugs actionable because of con- tamination with filth 210 Drugs actionable because of de- viation from official or own standards 211 Page Drugs and devices actionable be- cause of false and misleading claims _. 212 Drugs actionable because of failure to bear a label containing an accurate statement of the quantity of the contents 215 Index __? _. 216 *For presence of a habit-forming narcotic without ?warning statement, see'Nos. 3701, 3702, 3705-3708; omission of, or unsatisfactory, ingredients statements, Nos. 3701, 3702, 3704-3706, 3710, 3715; failure to bear a label containing the name and place of business of the manufacturer, packer, or distributor, Nos. 3701- 3707, 3710. 203 221128-52 DIRECTIONS OR WARNING STATEMENTS 3701. Misbranding of amphetamine sulfate tablets and Seconal Sodium capsules. U. S. v. Robert M. Walker (Closson-Kelly Drugs), and James Mason. Plea of guilty by Robert M. Walker. Sentence of 6 months in jail on each of 3 counts, to run concurrently. Plea of not guilty by James Mason. Tried to a jury. Verdict of not guilty. (F. D. 0. No. 31284. Sample Nos. 29849-L to 29852-L, incl., 29976-L to 29979-L, incl.) INFORMATION FILED: November 28, 1951, Western District of Washington, against Robert M. Walker, trading as Closson-Kelly Drugs, at Seattle, Wash., and James Mason, an employee of Closson-Kelly Drugs. INTERSTATE SHIPMENT: Prior to the sales described below, various quantities of amphetamine sulfate tablets were shipped into the State of Washington, from New York, N. Y., and various quantities of Seconal Sodium capsules were shipped into the State of Washington, from Indianapolis, Ind. ALLEGED VIOLATION : On March 29 and 30 and April 2, 3, and 5, 1951, 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. NATURE OF CHARGE: Misbranding, Sections 502 (b) (1) and (2), the repackaged drugs failed to bear labels containing the name and place of business of the manufacturer, packer, or distributor, and accurate statements of the quantity of the contents; and, Section 502 (f) (1), the labeling of the repackaged drugs failed to bear any 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." Further misbranding, Section 502 (e) (1), the repackaged amphetamine sulfate tablets failed to bear a label containing the common or usual name of the drug. DISPOSITION: On March 26, 1952, James Mason having entered a plea of not guilty to each of the 6 counts in which he was charged, he was tried to a jury, which returned a verdict of not guilty. On April 10, 1952, Robert M. Walker changed his plea from not guilty to guilty on each of 3 counts of the information, and he was sentenced to 6 months in prison on each of these counts, the sentences to run concurrently. The remaining counts of the information against Robert M. Walker were dismissed- on motion of the Government.