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] 4761-4780 DRUGS AND DEVICES The cases reported herewith were instituted in the United States district courts by United States attorneys, acting upon reports submitted by the Department of Health, Education, and Welfare. They involve drugs and devices which were adulterated or misbranded within the meaning of the Act when introduced into and while in interstate commerce, or while held for sale after shipment in inter- state commerce. These cases involve (1) seizure proceedings which were termi- nated with the entry of default or consent decrees of condemnation or which were dismissed after trial; (2) criminal proceedings which were terminated upon pleas of guilty; (3) injunction proceedings terminated with the entry of injunctions; and (4) contempt proceedings for violation of an injunction which were dismissed. The seizure proceedings are civil actions taken against the goods alleged to be in violation, and the criminal, injunction, and contempt pro- ceedings are against the firms or individuals charged to be responsible for viola- tions. Published by direction of the Secretary of Health, Education, and Welfare. GEO. P. LABBICK, Commissioner of Food and Drug*. WASHINGTON, D. C, September 14,1956. Page Drugs requiring certificate or re- lease, for which none had been issued 196 Drugs in violation of prescription labeling requirements 197 Drugs and devices actionable be- cause of failure to bear ade- quate directions or warning statements 198 CONTENTS* Page Drugs actionable because of con- tamination with filth 203 Drugs actionable because of devia- tion from official or own stand- ards 204 Drugs actionable because of false and misleading claims 206 Index __ __ 215 . *For presence of a habit-farming narcotic without, warning statement, see No. #761; omission of, or unsatisfactory, Ingredients statements, No. 4761; sale under name of an- other drug, No. 4774 ; failure to bear a label containing an accurate statement of the quan- tity of the contents, No. 4761; failure to bear a label containing the name and place of business of the manufacturer, packer, ?r distributor, No. 4761. 395237-56 1 195 Adulteration, Section 501 (a) (1), the article consisted in part of a filthy sub- stance; 501 (c), the article was not subject to the provisions of Section 501 (b), and its strength differed from that which it purported or was represented to possess; Section 501 (d) <2>, the article was a drug, and a substance had been substituted wholly or in part therefor. Misbranding, Section 502 (a), the labeling of the article was false and mis- leading ; Section 502 (b), the article was in package form, and it failed to bear a label containing (1) the name and place of business of the manufacturer, packer, or distributor, and (2), an accurate statement of the quantity of contents; Section 502 (d), the article contained a chemical derivative of barbituric acid, and its label failed to bear the quantity or proportion of such derivative and in juxtaposition therewith the statement "Warning-May be habit forming"; Sec- tion 502 (e) (l),"the article was not designated solely by a name recognized in an official compendium, and its label failed to bear the common or usual name of ^he drug; Section 502 (e) (2), the article was not designated solely by a name recognized in an official compendium and was fabricated from two or more ingredients, and its label failed to bear the common or usual name of each active ingredient; Section 502 (f) (1), the labeling of the article failed to bear ade- quate directions for use; Section 502 (i) (3), the article was offered for sale under the name of another drug; Section 502 (1), the article purported to be and was represented as a drug composed wholly or partly of a kind of chlortetra- cycline or a derivative thereof, and it was not from a batch with respect to which a certificate or release had been issued pursuant to Section 507; Section 503 (b) (4), the article was subject to Section 503 (b) (1), and its label failed to bear the statement "Caution: Federal law prohibits dispensing without prescription." DRUGS REQUIRING CERTIFICATE OR RELEASE, FOR WHICH NONE HAD BEEN ISSUED 4761. Steclin capsules, Altepose tablets, and Feosol tablets. (F. D. C. No. 37952. S. Nos. 21-814/5 M, 21-817 M.) QUANTITY : 1 btl. containing 430 Steclin capsules, 1 btl. containing 300 Altepose tablets, and 1 btl. containing 1,900 Feosol tablets at Philadelphia, Pa. SHIPPED : 11-12-54 and 2-5-55, from Long Island, N. Y., by Carl H. Kaplan, t/a Economy Buying Service, Inc. LABEL IN PART : (Btl.) "500 Steclin," "1000 Altepose," and "Feosol Tab." LIBELED : 4-28-55, E. Dist. Pa. CHARGE: 502 (b) (1)-the three articles when shipped failed to bear labels containing the name and place of business of the manufacturer, packer, or distributor; 502 (b) (2)-the Steclin capsules and Feosol tablets failed to ?- bear labels containing an accurate statement of the quantity of contents; 502 (d)-the Altepose tablets contained a quantity of vinbarbital, a habit forming derivative of barbituric acid, and its label failed to state the quantity or proportion of such derivative and in juxtaposition therewith the statement: ? "Warning: May Be Habit Forming"; 502 (e) (1)-the label of the Steclin capsules failed to bear the common or usual name of the drug; 502 (e) (2)- I the label of the Altepose tablets smd.Feosol tablets failed to bear the common or usual name of each actiye ingredient; 502 (f) (1)-the labeling of the three 197 articles failed to bear adequate directions for use; 502 (1)-the Steclin capsules purported to be and were represented as a drug composed wholly or partly of a derivative of chlortetracycline, and they were not from a batch with respect to which a certificate or release had been issued pursuant to law; and 503 (b) (4)-the Steclin capsules and the Altepose tablets were drugs which were sub- ject to the provisions of 503 (b) (1), and their labels failed to bear the statement "Caution: Federal law prohibits dispensing without prescription." DISPOSITION : 7-27-55. Default-destruction. DRUGS IN VIOLATION OF PRESCRIPTION LABELING REQUIREMENTS* 4762.?Gray, white, and pink tablets containing, among other ingredients, amphet amine phosphate racemic, thyroid, atropine sulfate, and phenobarbital.