FOOD AND DRUG ADMINISTRATION NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD, DRUG, AND COSMETIC ACT [Given pursuant to section 705 of the Food, Prug, and Cosmetic Act] 4481-4500 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 Pepartment of Health, Education, and Welfare, and include, where indicated, the results of investigations by the Pepartment, prior to the institution of the proceedings. Published by direction of the Secretary of Health, Education, and Welfare. GEO. P. LAEBICK, Commissioner of Food and Drugs. WASHINGTON, P. C, October 10, 1955. CONTENTS* Page New drug shipped without effective application 420 ^Violative sales of prescription drugs 420 Drugs actionable because of failure to bear adequate directions or warning statements 422 Drugs for human use 422 Drugs for veterinary use 423 Page Drugs actionable because of de- viation from official or own standards 424 Drugs actionable because of false and misleading claims 425 Index 431 ?For cosmetic, actionable under the drug provisions of the Act, see No. 4500. 356725?55- 419 NEW DRUG SHIPPED WITHOUT EFFECTIVE APPLICATION 4481. ACTH-Gel and Adrenocaps. U. S. v. 15 Cartoned Vials * * * (and one other seizure action). (F. D. 0. Nos. 36552, 36558. Sample Nos. 58097-L to58099-L, incl.) LIBELS FILED : May 6,1954, Northern District of Illinois. ALLEGED SHIPMENT: On or about October 2 and 5 and November 4, 1953, by United Research Laboratories, Inc., from Philadelphia, Pa. PRODUCT: 20 cartoned vials of ACTH-Gel and 10 bottles of Adrenocaps at Chicago and La Grange Park, 111. LABEL, IN PART: (Carton and vial) "(United Research) 10 cc. Multiple Dose Vial?Sterile ACTH-GEL (Corticotropin in Gelatin) 20 U. S. P. Units per cc. Caution: New drug limited by Federal Law to investigational use * * * Contains: 0.5? Phenol"; (bottle) "50 Tablets Adrenocaps with Cortisone Acetate Each tablet contains: Ammonium Salicylate. ... 4 gr. Para-Aminobenzoic Acid (as the Potassium Salt). . . . 5 gr. Cortisone Ace- tate. ... 3 mg. Salicylamide. . . . 1 gr. Enteric Coated. * * * Caution: New Drug?Limited by Federal Law to Investigational Use." NATURE OF CHARGE: Section 505 (a), the articles were new drugs within the meaning of the law, and applications filed pursuant to the law were not effective with respect to such drugs. DISPOSITION: October 26 and 27, 1954. Default decrees of condemnation and destruction. VIOLATIVE SALES OF PRESCRIPTION DRUGS