3786. Adulteration and misbranding of phenobarbital and atropine sulfate
tablets, pentobarbital sodium capsules, phenobarbital tablets, thyroid
tablets, and phenacetin tablets. U. S. v. Cowley Pharmaceuticals, Inc.,
and Ben C. Cowley. Pleas of guilty. Fine of $500 against corporation
and fine of $100 against individual. (F. D. C. No. 32741. Sample Nos.
4810-L, 4815-L, 5355-L, 22833-L, 22836-L.)
INFORMATION FILED: May 8, 1952, District of Massachusetts, against Cowley
Pharmaceuticals, Inc., Worcester, Mass., and Ben C. Cowley, president and
treasurer of the corporation.
ALLEGED SHIPMENT : Between the approximate dates of November 24, 1950, and
April 24, 1951, from the State of Massachusetts into the States of Vermont,
New Hampshire, and New York.
NATURE OF CHARGE : Phenobarbital and atropine sulfate tablets. Adulteration,
Section 501 (c), the strength of the article differed from that which it was re-
presented to possess in that it was represented to contain ? grain phenobarbi-
tal per tablet, whereas it contained less than *4 grain of phenobarbital per
tablet. Misbranding, Section 502 (a), the label statement "Each tablet con-
tains : Phenobarbital USP ? gr." was false and misleading.
Pentobarbital sodium capsules. Adulteration, Section 501 (b), the article
was represented as "Pentobarbital Sodium Capsules," a drug the name of which
is recognized in the United States Pharmacopeia, an official compendium, and
its strength differed from the official standard in that it contained less than
90 percent of the labeled amount of sodium pentobarbital, the minimum per-
mitted by the standard. Misbranding, Section 502 (a), the label statement
"Capsules Sodium Pentobarbital * * * 100 mgs. (1? gr.)" was false
and misleading since each capsule of the article contained less than 100 mg.
(IV2 grs.) of pentobarbital sodium.
Phenobarbital tablets. Adulteration, Section 501 (b), the article was re-
presented as phenobarbital tablets, a drug the name of which is recognized in
the United States Pharmacopeia, an official compendium, and its strength dif-
fered from the official standard since it contained less than 94 percent of the
labeled amount of phenobarbital, the minimum permitted by the standard.  Mis-
branding, Section 502 (a), the label statement "Tablets Phenobarbital USP .
1 Grain" was false and misleading since it represented and suggested that each
tablet conformed to the requirements for phenobarbital tablets as specified in
the United States Pharmacopeia, whereas each tablet did not conform to such
requirements since each tablet contained less than 94 percent of the labeled
amount of phenobarbital, the minimum permitted by the Pharmacopeia.
Thyroid tablets. Adulteration, Secton 501 (b), the article was represented
as "Thyroid Tablets," a drug the name of which is recognized in the United
States Pharmacopeia, an official compendium, and its strength differed from;
the official standard in that the article contained an amount of iodine (I)
in thyroid combination equivalent to less than 0.17 percent of the labeled
amount of thyroid, the minimum permitted by the standard. Misbranding,
Section 502 (a), the label statement "Tablets Thyroid USP, 1 Gr." was
false and misleading since it represented and suggested that each tablet of
the article conformed to the requirements for thyroid tablets as specified in
the United States Pharmacopeia, whereas each tablet of the article did not
conform to such requirement since each tablet contained an amount of iodine
(I) in thyroid combination equivalent to less than 0.17 percent of the labeled
amount of thyroid.
Phenacetin tablets. Adulteration, Section 501 (b), the article was repre-
sented as a drug, the name of which (acetophenetidin tablets) is recognized
in the United States Pharmacopeia, an official compendium, and its strength
differed from the official standard since it contained less than 94 percent of
the labeled amount of acetophenetidin, the minimum permitted by the standard.
Misbranding, Section 502 (a), the label statement "Tablets Phenacetin
USP., 5 Grains" was false and misleading since it represented and suggested
that each tablet of the article conformed to the requirements for aceto-
phenetidin tablets as specified in the United States Pharmacopeia, whereas
each tablet did not conform to such requirements since each tablet contained
less than 94 percent of the labeled amount of acetophenetidin.
DISPOSITION: June 25, 1952. Pleas of guilty having been entered, the court
ordered that a fine of $500 be imposed against the corporation and that a
fine of $100 be imposed against the individual.