3855. Misbranding of amphetamine citrate tablets, pentobarbital sodium cap-
sules, and apiol and ergot. U. S. v. Charles Pizinger and Donald White.
Pleas of nolo contendere. Defendant Pizinger fined $1,500, plus costs,
and placed on probation for 3 years; Defendant White fined $500 and
placed also on probation for 3 years. (F. D. C. No. 31252. Sample Nos.
70181-K, 70182-K, 70188-K, 89805-K.)
INFORMATION FILED : November 28, 1951, District of Nebraska, against Charles
Pizinger, pharmacist and manager of the City Drug Store at 2823 Leavenworth
Street, Omaha, Nebr., and Donald White, an employee of the store.
AiiLEGED VIOLATION : On or about July 14, 17, and 25, 1950, while quantities of
amphetamine citrate tablets, pentobarbital sodium capsules, and apiol and
ergot capsules were being held for sale at the above-mentioned City Drug
Store after shipment in interstate commerce, various quantities of the drugs
were repacked and dispensed without a physician's prescription, which acts
resulted in the repackaged drugs being misbranded.
Defendant Pizinger was charged with causing the repacking and dispensing
of each of the drugs involved in three different counts of the information, and
Defendant White was charged with causing such acts to be done with respect
to a quantity of pentobarbital sodium capsules as alleged in an additional
count in the information.
NATURE OF CHARGE: Misbranding, Section 502 (b) (2), the repackaged drugs
failed to bear labels containing accurate statements of the quantity of the
contents; and, Section 502 (f) (1), the labeling of the repackaged drugs
failed to bear adequate directions for use.
Further misbranding, Section 502 (b) (1), the repackaged pentobarbital
sodium capsules and apiol and ergot capsules failed to bear labels of the
manufacturer, packer, or distributor.
Further misbranding, Section 502 (d), the repackaged 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
repackaged capsules failed to bear a label containing the name, and quantity
or proportion of such derivative and in juxtaposition therewith the statement
"Warning-May be habit forming."
Further misbranding, Section 502 (e) (1), the repackaged amphetamine
citrate tablets failed to bear a label containing the common or usual name of
the drug; Section 502 (e) (2), the repackaged apiol and ergot capsules were
fabricated from two or more ingredients, and they failed to bear a label
containing the common or usual name of each active ingredient; and, Section
502 (f) (2), the repackaged apiol and ergot capsules failed to bear labeling
containing adequate warnings against use in those pathological conditions
where their use may be dangerous to health, and against unsafe dosage and
methods and duration of administration, in such manner and form, as are
necessary for the protection of users.
DISPOSITION : A motion for a bill of particulars was filed by the defendants on
January 3, 1952, and was overruled by the court, with the exception of that
part in which the Government was requested to show how the defendants
"caused" the various drugs to be repacked and dispensed. In accordance with
such ruling, the Government filed a bill of particulars on April 23,1952. There-
after a motion for dismissal of the information was filed on behalf of the
defendants, and after consideration of the arguments of counsel, it was over-
ruled by the court on May 29, 1952.   Pleas of nolo contendere subsequently
were entered on behalf of the defendants, and on October 30, 1952, Defendant
Pizinger was fined $1,500, plus costs, and Defendant White was fined $500.
Each defendant also was placed on probation for 3 years.