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U.S. Department of Health, Education, and Welfare

FOOD AND DRUG ADMINISTRATION

NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD,
DRUG, AND COSMETIC ACT

THE VERSITY Given pursuant to section 705 of the Food, Drug, and Cosmetic AcOF MICHIGAN 7.3141-5120 5741-5780

DRUGS AND DEVICES

APR 19 1960

LIBRARY

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 interstate commerce. These cases involve (1) seizure proceedings in which decrees of condemnation were entered after default or consent; (2) criminal proceedings terminated by a plea of guilty or nolo contendere or by a judgment of acquittal after trial; and (3) an injunction proceeding terminated by entry of a permanent injunction. 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 responsible for violations.

Published by direction of the Secretary of Health, Education, and Welfare.
GEO. P. LARRICK, Commissioner of Food and Drugs.

*For omission of, or unsatisfactory, ingredient statements, see Nos. 5741, 5745, 5761, 5763; failure to bear aabel containing an accurate statement of the quantity of the contents, Nos. 5741, 5745; failure to bear 1 label containing the name and place of business of the manufacturer, packer, or distributor, No. 5745; cosmetics actionable under the drug provisions of the Act, see Nos. 5750, 5770, 5771.

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131

SECTIONS of federal FOOD, DRUG, AND COSMETIC ACT INVOLVED IN VIOLATIONS REPORTED IN D.D.N.J. NOS. 5741-5780

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 (United States Pharmacopeia), and its strength differed from, and its quality and purity fell below, 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 misleading; 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(e) (2), the article was a drug 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 including the quantity and kind of alcohol; 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 (1), the article was, or purported to be, or was represented as, a drug composed wholly or partly of tetracycline, a derivative of chlortetracycline, 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) (1), the article was dispensed without a prescription from a practitioner licensed by law to administer the article; 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."

DRUGS REQUIRING CERTIFICATE OR RELEASE, FOR WHICH NONE HAD BEEN ISSUED

5741. Achromycin capsules. (F.D.C. No. 42171. S. No. 4-823 P.) QUANTITY: 2 btls. containing a total of 419 Achromycin capsules at Greenbelt, Md., in possession of State Drugs, Inc. (Greenbelt Pharmacy). SHIPPED: The capsules were manufactured in the State of New York, and delivered to the dealer at Greenbelt, Md., by an unknown person, sometime prior to 6-24-58.

LABEL IN PART: (Btl.) "Greenbelt Pharmacy * 131 Centerway Greenbelt, Md. No. - Dr. Achromycin 'V'."

RESULTS OF INVESTIGATION: The article was in the form of physicians' samples when delivered to the dealer, and after such delivery the article was repackaged into the above-mentioned bottles.

Analysis showed that the article contained approximately 250 milligrams of tetracycline per capsule.

LIBELED: 9-4-58, Dist. Md.

CHARGE: 502(b) (2)—the label of the article, while held for sale, failed to bear an accurate statement of the quantity of contents; 502(e) (2)—the label of

3741-57809F AMERICA

NOTICES OF JUDGMENT

133 the article failed to state the active ingredient, tetracycline, by its common or usual name; 502 (1)—the article was composed wholly or partly of tetracycline, a derivative of chlortetracycline, and the article was not from a batch with respect to which a certificate or release had been issued pursuant to law; and 503 (b) (4)—the article was subject to the provisions of 503 (b) (1), and its label failed to bear the statement "Caution: Federal law prohibits dispensing without prescription."

DISPOSITION: 10-31-58. Default-destruction.

5742. Cosa-Tetracyn capsules, Signemycin capsules, and Tetracyn tablets. F.D.C. No. 42229. S. Nos. 4-862/4 P.)

QUANTITY: 2 72-capsule btls. of Cosa-Tetracyn capsules, 1 18-capsule btl. of
Signemycin capsules, and 1 23-tablet btl., and 1 8-tablet btl. of Tetracyn
tablets, at Washington, D.C., in possession of Bretler's Pharmacy.
SHIPPED: Between December 1957 and 9-4-58, from Hillcrest Heights, Md.
RESULTS OF INVESTIGATION: The articles were repackaged by the consignee.

CHARGE: 502 (1)—the articles contained tetracycline and, while held for sale, were not from a batch with respect to which a certificate or release issued pursuant to law was in effect.

5743. Various drugs. (F.D.C. No. 42228. S. Nos. 4-855/61 P.) QUANTITY: 1 195-capsule btl., 1 144-capsule btl., 1 67-capsule btl., and 1 59-capsule btl., of Cosa-Tetracyn; 1 94-capsule btl., of Cosa-Signemycin; 2 100-capsule btls., of Cosa-Terramycin; 1 btl. containing 14 oz. of Tetrabon V; 8 2-oz. btls., of Tetra V; 1 btl. containing 16 oz., and 1 btl. containing 12 oz., of Signemycin syrup; and 3 2-oz. btls., and 1 16-oz. btl., of Terrabon syrup, at Hillcrest Heights, Md., in possession of Hillcrest Heights Drug, Inc. SHIPPED: 5-6-58 and 5-14-58, from Alexandria, Va.

RESULTS OF INVESTIGATION: The articles were repackaged by the dealer from physicians' samples after shipment as described above. LIBELED: 10-14–58, Dist. Md.

502 (1)

CHARGE: All articles, except Cosa-Terramycin and Terrabon syrup. while held for sale, the articles contained tetracycline and were not from a batch with respect to which a certificate or release was in effect. Cosa-Terramycin. 502(b) (2)—while held for sale, the article failed to bear a label containing an accurate statement of the quantity of contents. Terrabon syrup. 502(b)-while held for sale, the article 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; 502 (e) (2)—the label of the article failed to bear the common or usual name of each active ingredient; 502(f) (1)—the label of the article failed to bear adequate directions for use; and 503 (b) (4)—the article was a drug subject to 503 (b)(1) and its label failed to bear the statement "Caution: Federal law prohibits dispensing without prescription."

DISPOSITION: 12-18-58. Default-destruction.