FOOD AND DRUG ADMINISTRATION
NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD,
DRUG, AND COSMETIC ACT
[Given pursuant to section 705 of the Pood, Drug, and Cosmetic Act]
5481-5500
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; (2) criminal
proceedings terminated upon pleas of guilty; and (3) injunction proceedings in
which decrees of injunction were entered with the consent of the parties, or
after default. 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. LAEEICK, Commissioner of Food and Drugs.
WASHINGTON, D.O., May 27,1959.
CONTENTS*
Page
Drugs actionable because of poten-
tial danger when used accord-
ing to directions 
368
New drugs shipped without effec-
tive application 
369
Drugs requiring certificate or re-
lease, for which none had been
issued 
370
Drugs in violation of prescription
labeling requirements 
371
Drugs and devices actionable be-
cause of failure to bear ade-
quate directions or warning
statements 
372
Page
Drugs actionable because of devia-
tion from official or own stand-
ards 
375
Drugs actionable because of false
..and misleading claims 
377
Drug actionable because of failure
to comply with packaging re-
quirements of an official com-
pendium 
381
Index 
382
?For presence of a habit-forming substance without warning statement, see No. 5485;
omission of, or unsatisfactory, ingredients statements, Nos. 5485, 5486; sale under name
of another drug, No. 5481; failure to bear a label containing an accurate statement of
the quantity of the contents, No. 5486; failure to bear a label containing the name and
place of business of the manufacturer, packer, or distributor, Nos. 5486, 5487.
504893-59 1 
367
SECTIONS OF FEDERAL FOOD, DRUG, AND COSMETIC ACT INVOLVED IN VIOLATIONS
REPORTED  IN DJ)JfJ.  NOS.   S48IS500
Adulteration, Section 501(b), the article purported to be and waa repre-
sented 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 and quality differed from that which it purported or was represented
to possess; and 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 con-
tents; Section 502(d), the article contained a chemical derivative of barbituric
acid, and its label failed to bear the name, and quantity or proportion of such
derivative and in juxtaposition therewith the statement "Warning-May be habit
forming"; 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, kind, and proportion of alcohol, and
the name, and quantity or proportion of atropine, hyoscine, and hyoscyamine
contained therein; Section 502(f) (1), the labeling of the article failed to bear
adequate directions for use; Section 502(g), the article purported to be a
drug, the name of which is recognized in an official compendium (United States
Pharmacopeia), and it was not packaged as prescribed therein; Section
502 (i) (3), the article was a drug offered for sale under the name of another
drug: Section 502(j), the article was dangerous to health when used in the
dosage, or with the frequency or duration, prescribed, recommended, or sug-
gested in the labelingi Section 502(1) (2), the article was, or purported to be,
or was represented as, a drug composed wholly or partly of penicillin; and
It was from a batch with respect to which a certificate issued pursuant to Sec-
tion 507 was not in effect; 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."
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.
DRUGS ACTIONABLE BECAUSE OF POTENTIAL DANGER WHEN USED
ACCORDING TO DIRECTIONS
5481. Castor oil and hydrogen peroxide solution. (F.D.C. No. 40474. S. Nos.
24-038 M, 50-722 M, 50-821 M.)
INFORMATION FILED : 2-10-58, S. Dist. Calif., against Norton Chemical Co., Inc.,
t/a Norton Products Co., Los Angeles, Calif.
ALLEGED VIOLATION : During the year of 1956, while a quantity of turpentine was
being held for sale at Los Angeles, Calif., after shipment in interstate com-
merce, the defendant caused the turpentine to be repacked into bottles labeled,
in part, as "Norco Castor Oil," which act resulted in the article being adul-
terated and misbranded as described below.
In addition, between 1-15-57 and 1-24-57, the defendant caused to be in-
troduced into interstate commerce, at Los Angeles, Calif., for delivery to
Phoenix, Ariz., a quantity of an article labeled, in part, "Enterprise Solution
of Hydrogen Peroxide U.S.P. 10 Volume xk Lb. (4 Oz. Av.) Enterprise
Drug & Chemical Company Los Angeles, Calif.," which was adulterated as
described below.
CHARGE: Castor oil. 501(d)(2)-.turpentine had been substituted for castor
oil, which the article was represented to be; 502(a)-the label statement
"Castor Oil" was false and misleading; 502(i) (3)-the article was turpentine,
and it was offered for sale under the name of another drug, namely, castor oil;
and 502(j)-the article was dangerous to health when used in the dosage
prescribed, recommended, and suggested in its labeling, namely, "Dose: Chil-
dren, one to two teaspoonfuls.   Adults, one to two tablespoonfuls."
Hydrogen peroxide solution. 501(b)-the quality and purity of the article
fell below the standard for liydrogen peroxide solution set forth in the United
States Pharmacopeia since the article contained isopropyl alcohol, which is
not permitted in such standard.
PLEA :   Guilty.
DISPOSITION:   4-21-58.   $1,500 fine.
NEW DRUGS SHIPPED WITHOUT EFFECTIVE APPLICATION