3643. Misbranding of pentobarbital sodium capsules, Dexedrine Sulfate tablets,
and sulfadiazine tablets. U. S. v. Bond Drug Store, Harold G. Griffin,
and Robert V. West. Pleas of guilty. Fine of $135, plus costs, against
individuals jointly.   No fine imposed against partnership.    (F. D. C.
No. 30567.   Sample Nos. 76956-K, 7696^K, 76977-K, 76978-K, 77147-K,
77772-K, 78216-K, 78218-K.)
INFORMATION FILED : April 26, 1951, Western District of Missouri, against the
Bond Drug Store, a partnership, Lebanon, Mo., and Harold G. Griffin, a
partner in the partnership, and Robert V. West, a pharmacist for the partner-
ship.
INTERSTATE SHIPMENT : From the States of Illinois, Indiana, and Pennsylvania,
into the State of Missouri, of quantities of pentobarbital sodium capsules,
Dexedrine Sulfate tablets, and sulfadiazine tablets.
ALLEGED VIOLATION : On or about May 21, June 12 and 17, and July 5, 6, and 12,
1950, while the drugs were being held for sale at the Bond Drug Store after
shipment in interstate commerce, various quantities of the drugs were repacked
and sold without a prescription, which acts resulted in the repackaged
drugs being misbranded.
? The Bond Drug Store and Harold G. Griffin were charged with causing the
acts of repacking and sale of the drugs involved in each of the 8 counts of
the information, and, in addition, Robert V. West was charged in 2 of the counts
with causing such acts to be done in connection with the drug involved in
those counts.
NATURE OF CHARGE: Misbranding, 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 cap-
sules contained a derivative of barbituric acid, which derivative has been found
to be, and by regulations designated as, habit forming; and the label 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 (e) (1), the repackaged Dexedrine Sulfate
tablets and the sulfadiazine tablets failed to bear labels containing the common
or usual name of the drugs; Section 502 (f) (1), the repackaged pentobarbital
sodium capsules and the Dexedrine Sulfate tablets failed to bear labeling con-
taining adequate directions for use since the directions "1 capsule at bedtime
when needed" and "one at bedtime as needed," borne on the labeling of the
repackaged pentobarbital sodium capsules, and the directions "2 tablets each
morning," borne on the labeling of the repackaged Dexedrine Sulfate tablets,
were not adequate directions for use; and, Section 502 (f) (2), the labeling of
the repackaged sulfadiazine tablets bore no warnings against use in those path-
ological conditions where their use may be dangerous to health, and against
unsafe dosage and methods and duration of administration.
DISPOSITION : May 7, 1951. Pleas of guilty having been entered, the court
imposed a fine of $135, plus costs, against the individual defendants jointly.
No fine was imposed against the partnership.