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] 5301-5320 DRUGS AND DEVICES The cases reported herewith were instituted in the United States district courts hy 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 terminated with the entry of default or consent decrees of condemnation; (2) criminal proceedings terminated upon a plea of nolo contendere or guilty or upon a verdict of guilty; and (3) injunction proceedings terminated upon the granting of a motion for summary judgment. The seizure proceedings are civil actions taken against the goods alleged to be in violation; the criminal pro- ceedings are against the firms or individuals charged to be responsible for violations; and the injunction proceedings are against the Government. Published by direction of the Secretary of Health, Education, and Welfare. GEO. P. LAERICK, Commissioner of Food and Drugs. WASHINGTON, D. C, December It, 1958. CONTENTS Page Drugs actionable because of poten- tial danger when used accord- ing to directions 220 New drugs shipped without effec- tive application 221 Drugs for veterinary use 222 Drug requiring certificate or re- lease, for which none had been issued 222 Drugs in violation of prescription labeling requirements 223 Page 486507-58- Drugs and devices actionable be- cause of failure to bear ade- quate directions or warning statements 223 Drugs and devices actionable be- cause of deviation from official or own standards 237 Drugs and devices actionable be- cause of false and misleading claims 238 Drugs for human use 238 Drug for veterinary use 243 219 ./- -vt/! SECTIONS OF FEDERAL FOOD, DRUG, AND COSMETIC ACT INVOLVED IN VIOLATIONS REPORTED IN D. D. N. J. NOS. 5301-5320 Adulteration, Section 501 (b), the article purported to be and was represented as a drug, the name of which is recognized in an official compendium (National Formulary), and its strength differed from the standard set forth in such com- pendium; Section 501 (c), the article was not subject to the provisions of Section 501 (b), and its strength differed from, or its purity or quality fell below, that which it purported or was represented to possess. Misbranding,-Section 502 (a), the labeling of the article was false and mis- leading; Section 502 (f) (1), the labeling of the article failed to bear adequate directions for use; Section 502 (j), the article was dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in its labeling; Section 502 (1), the article purported to be and was represented as a drug composed partly of a kind of penicillin, chlortetracycline* or Chloromycetin, 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 state- ment "Caution: Federal law prohibits dispensing without prescription." Neto-drug violation, Section 505 (a), the article was a new drug within the meaning of Section 201 (p), which was introduced into interstate commerce, and an application filed pursuant to Section 505 (b) was not effective with respect to such drug. Publicity, Section 705 (a), the Secretary shall cause to be published from time to time reports summarizing all judgments, decrees, and court orders which have been rendered under this Act, including the nature of the charge and the dis- position thereof; Section 705 (b), the Secretary may also cause to be disseminated information regarding food, drugs, devices, or cosmetics in situations involving, in the opinion of the Secretary, imminent danger to health, or gross deception of the consumer. Nothing in this section shall be construed to prohibit the Secretary from collecting, reporting, and illustrating the results of the investi- gations of the Department. DRUGS ACTIONABLE BECAUSE OF POTENTIAL DANGER WHEN USED ACCORDING TO DIRECTIONS 5301. Various drugs. (F. D. C. No. 39209. S. Nos. 23-845/6 M, 30-305 M, 31-774 M.) INFORMATION FILED: 12-26-56, N. Dist. 111., against Medical Chemical Corp., Chicago, HI., and Bernard B. Speiser, president. SHIPPED : Between 7-2-55 and 9-17-55, from Illinois to Arizona, Indiana, and Tennessee. LABEL HT PABT: (Vial) "Intramuscular-10 cc-Shake Well Triple Hormone Suspension Each cc Contains-Esterone U. S. P. 6 mg.-Testosterone TL S. P. 25 mg.-Progesterone 5 mg.-Pectin 0.35?-Thimerosal 1:20,000-Sodium Acetate 0.8? Distributed by Myers-Carter Labs., Inc. * * * Phoenix, Arizona," "Sterile Multiple Dose 10 cc Progesterone U. S. P. 50 mg/cc In Buffered Aqueous Suspension Pectin 0.2?-Thimerosal 1:20,000 Intramuscular Myers-Carter Laboratories, Inc. Phoenix, Arizona," and "Sterile 10 cc Vial Testosterone TJ. S. P. 50 mg/cc In aqueous suspension Sod. Acetate 0.8?- Pectin 0.35? Thimerosal 1:20,000 Intramuscular Average Dose: 25 mg./ Mfg'd for G and G Pharmacal Co. Inc. South Bend, Ind."; (ampul) "A-5o 10 cc. Calcium Gluconate U. ?S. P. 10? Solution W/V in ampul water no preservative Intramuscular and Intravenous Morton Pharmaceuticals Inc.- Ethical Distributors Memphis, Tenn." RESULTS OP INVESTIGATION : Examination of the calcium gluconate showed that it was pyrogenic and that the other drugs involved were not sterile as repre- sented but were contaminated with viable micro-organisms. CHARGE: 501 (c)-the purity and quality of the triple hormone suspension and the testosterone, when shipped, fell below that which they purported and were represented to possess; 502 (a)-the labels of the progesterone and testos- terone, when shipped, contained false and misleading statements that the articles were sterile; and 502 (j)-when shipped, the calcium gluconate was dangerous to health when used in the dosage and with the frequency and duration prescribed, recommended, and suggested in its labeling, namely, "Usual Dose: Adults, intravenous or intramuscular 1 Gram daily or on alternate days; for children, intravenous 0.02 to 0.5 Gram." PXEA : Nolo contendere. DISPOSITION : 5-29-57. $1,250 fine, plus costs. NEW DRUGS SHIPPED WITHOUT EFFECTIVE APPLICATION