3410. Misbranding of thyroid tablets, diethylstilbestrol tablets, Amytal tablets,
sulfadiazine and sodium bicarbonate tablets, and sulfathiazole tablets.
IT. S. v. Seybold Drug Co.   Plea of guilty.   Fine, $700.    (F. D. C. No.
29455.    Sample Nos.  2708S-K,  27092-K,  76522-K,  70523-K,  76525-K,
76527-K, 76544-K.)
INFORMATION FILED : September 26* 1950, Eastern District of Missouri, against
the Seybold Drug Co., a corporation, Poplar Bluff, Mo.
INTERSTATE SHIPMENT : From the States of Michigan, Indiana, and Tennessee
into the State of Missouri, of quantities of thyroid tablets, diethylstilbestrol
tablets, Anvgfal tablets, sulfadiazine and sodium bicarbonate tablets, and sul-
fathiazole tablets.
ALLEGED VIOLATION : On or about December 28 and 29, 1949, and January 9, 10,
and 12, 1950, while the drugs were being held for sale after shipment in inter-
state commerce, the defendant caused quantities of the drugs to be repackaged
and sold without a prescription, which acts resulted in the repackaged drugs
being misbranded.
NATURE OF CHARGE: Misbranding, Section 502 (b) (2), the repackaged drugs
failed to bear labels containing statements of the quantity of the contents;
? Section 502 (f) (1), the labeling of the repackaged drug^ failed to bear ade-
quate directions for use since the directions "As directed'* borne on the labeling
of the diethylstilbestrol toilets and the sulfathiazole tablets and the directions
"One as needed" borne on the labeling of a portion of the repackaged Amytal
tablets were not adequate directions for use, and since the labeling of the
remainder of the repackaged drugs bore no directions for use; and, Section
502 (b) (1), the repackaged drugs other than the sulfathiazole tablets bore
no labels containing the name and place of business of the manufacturer,
packer, or distributor.
Further misbranding, Section 502" (d), the Amytal tablets contained a chemi-
cal derivative of barbituric acid, which derivative has been found to be, and
by regulations designated as, habit forming; and the label of the repackaged
Amytal tablets 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 diethylstilbestrol
tablets and the sulfathiazole tablets bore no labels containing the common or
usual name of the drugs; Section 502 (e) (2), the repackaged sulfadiazine
and sodium bicarbonate tablets failed to bear the common or usual name of
each active ingredient of the tablets; and, Section 502 (f)   (2), the labeling
of the sulfadiazine and sodium bicarbonate tablets and the sulfathiazole   (
tablets bore no warning against use in those pathological conditions where
their use may be dangerous to health, and against unsafe dosage and methods
and duration of administration.
DISPOSITION : March 27,1951. A plea of guilty having been entered, the court
imposed a fine of $700 against the defendant.