U.S. Department of Health, Education, and Welfare
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]
6481-6500
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 de-
crees of condemnation were entered after default or consent; (2) a criminal
proceeding terminated upon a plea of guilty; and (3) an injunction proceeding
terminated upon the entry of a permanent injunction by consent. 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. LABBICK, Commissioner of Food and Drugs.
WASHINGTON, D.C., March 23, 1962.
CONTENTS*
Page
New drugs shipped without effective
application 
350
Violative    sales    of    prescription
drugs 
351
Drugs actionable because of failure
to bear adequate directions or
warning statements 
3 52
Page
Drugs and device actionable be-
cause of deviation from official
or own standards 
355
Drugs and device actionable be-
cause of false and misleading
claims 
359
Index 
370
*For presence of a habit-forming substance without warning statements, see No. 6481; an imitation of, and
sale under name of, another drug, No. 6482; failure to bear a label containing the name and place of business
of the manufacturer, packer, or distributor, No. 6484.
629973-62 1 
349
SECTIONS OF FEDERAL FOOD, DRUG, AND COSMETIC ACT INVOLVED IN VIOLATIONS
REPORTED IN DJ>.NJ. NOS. 6481-6500
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, or its quality 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 mis-
leading; Section 502(b) (1), the article was in package form, and it failed to
bear a label containing the name and place of business of the manufacturer,
packer, or distributor; Section 502(d), the article contained a chemical deriva-
tive 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(f), the labeling of the article
failed to bear (1) adequate directions for use, and (2) adequate warnings
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(i) (3), the
article was offered for sale under the name of another drug; and Section 503
(b) (1), the article was dispensed without a prescription from a practitioner
licensed by law to administer the article.
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
6481. Delfetamine Stedytabs and Delfeta-Sed Stedytabs.    (F.D.C. No. 44603.
S.Nos. 4-020/1 R.)
QUANTITY : 2 drums, each containing about 50,000 tablets, and 118 30-tablet
ctns., of Delfetamvne Stedytabs, and 278 30-tablet ctns., of Delfeta-Sed
Stedytabs, at Baltimore, Md., in possession of Eastern Research Laboratories,
Inc.
SHIPPED: Between 11-16-58 and 3-21-60, from St. Louis, Mo., by Victor M.
Hermelin & Co.
LABEL IN PAST: (Drum) "Delfetamine, 30 Mg. Stedytabs Each tablet con-
tains : *Delfatamine 30 mg. Caution * * * Average dose * * * Manufactured
by a special process * * * to provide prolonged continuous therapeutic effect
from active ingredient over a period up to 8-12 hours. * Registered Trademark
of dl-N-methyl-beta-phenylisopropylamine Hydrochloride. Victor M. Hermelin
and Company, New Products Division of K-V Pharmacal Company, St. Louis
17, Missouri"; (ctn.) "Stedytabs Sustained Release Tablets Delfetamine
dextro-levo N-methylamphetamine HC1 * * * Eastern Research Laboratories,
Inc., Baltimore 1, Maryland"; and "Stedytabs Sustained Release Tablets
Delfeta-sed Delfetamine With Sedafax * * * Eastern Research Labora-
tories, Inc., Baltimore 1, Maryland."
RESULTS OF INVESTIGATION :    Examination showed that the articles contained
(Delfetamine Stedytabs) methamphetamine HC1, and (Delfeta-Sed Stedytabs)
methamphetamine HC1 and amobarbital.    The tablets in the cartons were
repacked by the dealer from bulk stock shipped as described above.
LIBELED :   6-3-60, Dist. Md.
CHARGE: 502(d)-while held for sale, the Delfeta-Sed Stedytabs contained a
habit forming drug, amobarbital, a derivative of barbituric acid, and their
label failed to bear the name of the drug and in juxtaposition therewith the
statement "Warning-May be habit forming"; and 505(a)-the Delfetamine
Stedytabs and the Delfeta-Sed Stedytabs were new drugs which may not be
introduced into interstate commerce since applications filed pursuant to the
law were not effective with respect to such drugs.
DISPOSITION :   8-8-60.   Default-destruction.
6482.?Meprobamate tablets, chlorothiazide tablets, and hydrochlorothiazide tab