6540. (F.D.C. No. 45201. S. Nos. 13-148/9 P, 13-151/6 P.) INFORMATION FILED : 4-7-61, E. Dist. Mich., against Sussex Pharmacy (a part- nership), Warren, Mich., and Lewis Kahn and William Burk (partners in the partnership). CHARGE : Between 12-12-59 and 12-21-59, Achromycin capsules (counts 1, 2, and 5) were dispensed 3 times; dextro-amphetamine sulfate capsules (counts 3 and 8) and dextro-amphetamine sulfate tablets (counts 4 and 6) were each dispensed twice; and penicillin G potassium tablets (count 7) were dispensed once without a prescription. PLEA : Guilty by the partnership to all 8 counts of the information; by Burk to counts 3, 4, 5, 6, 7, and 8; and by Kahn to counts 1, 2, 3, 5, 6, and 7. DISPOSITION : 5-17-61. Partnership fined $400; each individual fined $600. INDEX TO NOTICES OF JUDGMENT D.D.NJ. NOS. 6501 TO 6540 PRODUCTS N.J. No. Achromycin capsules 6540 AM Plus capsules 6537 Amphetamine, dextro-, sulfate capsules 6518, 6540 tablets 6507, 6511, 6514-6517, 6519, 6540 sulfate tablets 6501-16513, '6522, 6527, 6528, '6532 Chloromycetin capsules 6533, 6539 Decadron tablets 6533 Desoxyephedrine hydrochloride tablets, 6507, 6508, 6511, 6526, 6527 Dexamyl tablets 6510, ' 6520 Dexedrine Spansule capsules- 6506 Sulfate tablets ' 6520-6525 Dextro-amphetamine sulfate cap- sules 6518, 6540 sulfate tablets 6507, 6511, 6514-6517, 6519, 6540 N.J. No. Diphetamine tablets 6536 Equanil tablets 6525, 6529 Medrol tablets 6535 Meticorten tablets 6539 Miltown tablets 6519,6524,6535 Nembutal Sodium capsules '6521, 16522, 6538, 6539 Penicillin G potassium tablets.- 6531, '6534,6540 Pentobarbital sodium capsules '6522, '6532 Prednisone tablets '6534 Preludin tablets 6535 Secobarbital sodium capsules '6520, 6528, 6529, 6534 Seconal Sodium capsules 6519, ' 6521, 6525, 6530 Thyroid tablets 6535 Tuinal capsules 6530, ' 6532 1 (6513, 6520, 6521, 6522, 6532, 6534.) Prosecution contested. The cases reported herewith were instituted in the United States district courts by United States attorneys, acting upon reports submitted by the De- partment 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 interstate commerce. These cases involve (1) seizure proceedings in which decrees of condemnation were entered after default or consent, or in one case each, after trial by the court or motion for summary judgment; (2) criminal proceedings which were terminated upon pleas of guilty and upon a judgments guilty after trial; (3) a contempt proceeding for violation of an injunction which was terminated upon a plea of guilty; and (4) injunction pro- ceedings terminated upon the entry of a permanent injunction by consent, and upon the entry of a permanent injunction following the reversal by the appel- late court of the judgment of the trial court. The seizure proceedings are civil actions taken against the goods alleged to be in violation, and the criminal and injunction proceedings are against the firms or individuals charged to be re- sponsible for violations. Published by direction of the Secretary of Health, Education, and Welfare. GEO. P. LAREICK, Commissioner of Food and Drugs. WASHINGTON1, D.C., June 4,1962. CONTENTS* Page New drugs shipped without effec- tive application 16 Drugs requiring certificate or re- lease, for which none had been issued 18 Drug for human use 18 Drug for veterinary use 18 Drugs in violation of prescription labeling requirements 19 Drugs and devices actionable be- cause of failure to bear ade- quate directions or warning statements 25 Page Drugs and devices actionable be- cause of deviation from offi- cial or own standards 49 Drugs and devices actionable be- cause of false and misleading claims 52 Index 62 *For presence of a habit-forming substance without warning statements, see Nos. 6546, 6518; omission of, or unsatisfactory, ingredients statements, Nos. 6546, 6548; an imitation of another drug, No. 6574; failure to bear a label containing an accurate statement of the quantity of the contents, No. 6548; failure to bear a Label containing the name and place of business of the manufacturer, packer, or distributor, No. 6548; label- ing information not Ukely to be read and understood by the ordinary individual under customary conditions of purchase and use, No. 6558. SECTIONS OF FEDERAL FOOD, DRUG, AND COSMETIC ACT INVOLVED IN VIOLATIONS REPORTED IN D.D.NJ. NOS. 6541-6580 Adulteration, Section 501(b), the article purported to be and was represented as a drag, the name of which is recognized in an official compendium (United States Pharmacopeia), and its strength differed from the standard set forth in such compendium; and 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(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 the contents in terms of weight, measure, or numerical count; Section 502(e), a word, statement, or other information required by, or under authority of, the Act to appear on the label or labeling of the article was not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary con- ditions of purchase and use; Section 502(d), the article was for use by man and contained a quantity of peyote or other named narcotic or hypnotic sub- stance, or a chemical derivative of such substance, which derivative had been by regulations designated as habit forming, and its label failed to bear the name, and quantity or proportion of such substance or derivative and, in juxtaposition therewith, the statement "Warning-May be habit forming"; Section 502(e), the article was a drug not designated solely by a name recognized in an official compendium, and its label failed to bear (1) the common or usual name of the drug; and (2), in the case where the article was fabricated from two or more ingredients, the common or usual name of each active ingredient; Section 502(f), the labeling of the article failed to bear (1) adequate directions for use, and (2) adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users; Section 502(i) (2), the article was an imitation of another drug; Section 502(1), the article was composed wholly or in part of a kind of penicillin, or streptomycin, and was not from a batch with respect to which a certificate or release had been issued pursuant to Section 507; and Section 503(b) (4), the article was a drug subject to Section 503(b) (1), and its label failed to bear the statement "Caution: Federal law prohibits dispensing without prescription." New-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. NEW DRUGS SHIPPED WITHOUT EFFECTIVE APPLICATION