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]
5561-5580
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 Depart-
ment 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 and (2) criminal
proceedings terminated upon pleas of guilty. The seizure proceedings are civil
actions taken against the goods alleged to be in violation, and the criminal
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. LAKBICK, Commissioner of Food and Drugs.
WASHINGTON, D.C., August 18, 1959
Page
Violative    sales    of    prescription
drugs-.-
    28
Drug in violation of prescription
labeling requirements?    29
Drugs actionable because of con-
tamination with filth?    30
CONTENTS*
Page
Drugs and devices actionable be-
cause of deviation from official
or own standards 
    30
Drugs actionable because of false
and misleading claims-.     35
Index   
    36
?For failure to bear adequate directions or warning statements, see No. 5561; omission
of, or unsatisfactory, ingredients statements, Nos. 5561, 5562; failure to bear label contain-
ing an accurate statement of the quantity of the contents, No. 5561.
514148-59
SECTIONS OF FEDERAL FOOD, DRUG, AND COSMETIC ACT INVOLVED IN VIOLATIONS
REPORTED IN DJ).NJ. NOS. 5561-5580
Adulteration, Section 501(a) (1), the article consisted in part of a filthy sub-
stance; Section 501(a) (2), the article had been prepared under insanitary con-
ditions; 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; Section 501(c), the article
was not subject to the provisions of Section 501(b), and its strength differed
from, or its 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) (2), the article was in package form, and it failed to
bear a label containing an accurate statement of the quantity of contents; Sec-
tion 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) the drug was fabricated from two or more in-
gredients, 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 adequate
directions for use; Section 503(b)(1), the article was dispensed without a
prescription from a practitioner licensed by law to administer the article; Sec-
tion 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 with-
out prescription."
VIOLATIVE SALES OF PRESCRIPTION DRUGS
5561. Various drugs.    (F.D.C. No. 40603.    S. Nos. 41-889/91 M, 55-785 M, 55-
787/9 M, 55-791 M, 84-801 M.)
INDICTMENT FTT.EP :   1-14-58, E. Dist. Ky., against John Byron Miller, t/a J. B.
Miller, pharmacist, Williamstown, Ky.
CHABGB: Between 6-1-57 and 6-12-57, penicillin tablets were dispensed three
times and cortisone acetate tablets were dispensed twice without a prescrip-
tion, which acts of dispensing were caused to be done by the defendant while
the tablets were being held for sale after shipment in interstate commerce
and which resulted in the tablets being misbranded under 503(b) (1).
In addition, various articles, namely, a number of pink tablets and
mephenesin tablets and quantities of a yellow oil and a liquid medicine were
caused to be introduced into interstate commerce by the defendant at Wil-
liamstown, Ky., for delivery to Albany, N.Y., and Nashville, Tenn., between
the latter part of 1956 and 7-15-57.   The articles were misbranded as follows:
502(b) (2)-the labels of the articles bore no statement of the quantity of
contents.
502(e) (1)-the labels of the articles failed to bear the common or usual
names of the articles.
502(e) (2)-the articles, other than the yellow oil, were fabricated from
two or more ingredients, and the labels failed to bear the common or usual
name of each active ingredient.
for use since the labeling failed to state the conditions and purposes for which
the articles were intended.
503(b) (1)-the mephenesin tablets were dispensed without a prescription.
PLEA :   Guilty.
DISPOSITION :   4-21-58.   Sentence of 90 days in jail and fine of $2,250.
DRUG IN VIOLATION OF PRESCRIPTION LABELING REQUIREMENTS