3166. Misbranding of. pentobarbital sodium capsules, Dexedrine Sulfate tablets,
and sulfonamides triplex tablets. U. S. v. Harry W. Schaum Drug. Co,
Harry W. Schaum, and Howard H. W. Schulze. Plea of guilty for com-
pany and pleas of nolo contendere for individual defendants. Fine of
$1,000 against company; sentences against individual defendants sus-
pended and these defendants placed on probation for 1 year. (F. D. C.
No. 29121. Sample Nos. 60922-K, 60924-K, 60926-K, 60930-K to 60932-K,
incl., 60959-K, 60975-K.)
INFORMATION FILED : May 23, 1950, Eastern District of Missouri, against the
Harry W. Schaum Drug Co., a partnership, St. Louis, Mo., and Harry W.
Schaum and Howard H. W. Schulze, partners and pharmacists.
INTERSTATE SHIPMENT : From the States of Illinois, Pennsylvania, and Indiana,
into the State of Missouri, of quantities of pentobarbital sodium capsules,
Dexedrine Sulfate tablets, and sulfonamides triple? tablets.
ALLEGED VIOLATION: On or about .July 7, 21, and 25, and August 21 and 24,
1949, while a number of the above-mentioned capsules and tablets were being
held for sale at the Harry W. Schaum Drug Co. after shipment in interstate
commerce, various quantities of the capsules and tablets were repacked and
sold without a prescription, which acts resulted in the repackaged tablets
and capsules being misbranded.
The Harry W. Schaum Drug Co. was charged with causing the acts of
repacking and sale of the drugs involved in each of the eight counts of the
information; and, in addition, Harry W. Schaum, in four of the counts, and
Howard H. W. Schulze, in the four other counts of the information, were
charged with causing such acts to be done in connection with the drugs involved
in those counts.
NATURE OF CHARGE: Misbranding, Section 502 (b) (1), a portion of the
sulfonamides triplex tablets failed to bear a label containing the name and
place of business of the manufacturer, packer, or distributor; and, Section
502 (b) (2), all of the repackaged drugs failed to bear labels containing
statements of the quantity of the contents.
Further misbranding, Section 502 (d), the pentobarbital sodium capsules
contained a chemical derivative of barbituric acid, which derivative has been
found to be, and by regulations designated as, habit forming; and the labels
of the repackaged capsules failed to bear the name, and quantity or proportion^
of such derivative and in juxtaposition therewith the statement "Warning-
?May be habit forming.
Further misbranding, Section 502 (f) (1), the repackaged drugs, with the
exception of the sulfonamides triplex tablets, failed to bear labeling containing
adequate directions for use since the directions for use "One at bedtime,"
borne on the labeling of the pentobarbital sodium capsules, were not adequate
directions for use, and since the Dexedrine Sulfate tablets bore no labeling
containing directions for use; and, Section 502 (f) (2), the labeling of the
sulfonamides triplex tablets bore no warnings against use in those pathological
conditions where their use may be dangerous to health, and against unsafe
dosage and methods of duration of administration.
DISPOSITION: June 12, 1950. A plea of guilty was entered on behalf of the
company, and a plea of nolo contendere was entered on behalf of each indi-
vidual defendant. The court, thereupon, imposed a fine of $1,000 against the
company, suspended the imposition of sentences against the individual defend-
ants, and placed the individuals on probation for 1 year.