3202. Alleged misbranding of Benadryl capsules, Benzedrine Sulfate tablets,
Dexedrine Sulfate tablets, and phenobarbital tablets. U. S. v. Earl S.
Fitzgerald (Fitzgerald Drug Store). Plea of nolo contendere. Case dis-
missed by court. (F. D. C. No. 26731. Sample Nos. 46195-K, 46196-K,
46229-K, 46230-K, 46438-K, 46439-K.)
INFORMATION FILED : September 23, 1949, Eastern District of Arkansas, against
Earl S. Fitzgerald, trading as the Fitzgerald Drug Store, Corning, Ark.
INTERSTATE SHIPMENT : Between the approximate dates of May 10 and Novem-
ber 9, 1948, from St. Louis, Mo., and Cairo, 111., into the State of Arkansas.
ALLEGED VIOLATION : On or about January 21 and 22 and February 1, 1949, and
while the drugs were being held for sale after shipment in interstate commerce,
the defendant caused quantities of the drugs to be repackaged and sold to vari-
ous persons without a prescription, which acts of the defendant resulted in the
repackaged drugs being misbranded.
NATURE OF CHARGE: Alleged misbranding, Sections 502 (b) (1) and (2), the
repackaged drugs failed to bear labels containing the name and place of busi-
ness of the manufacturer, packer, or distributor, and a statement of the quan-
tity of the contents; Section 502 (f) ,.(1), the labeling of the repackaged drugs
failed to bear adequate directions for use since the directions for use, "As
Directed" on the labeling of the Benadryl capsules, "One 9 A. M. and 3 P. M."
on the labeling of the Benzedrine Sulfate tablets, and "One Tablet night and
morning" on the labeling of one sale of the Dexedrine Sulfate tablets, were not
adequate directions for use, and since the labeling of the other sale of Dexe-
drine Sulfate tablets and phenobarbital tablets bore no directions for use.
Further misbranding, Section 502 (e) (1), the labeling of the repackaged
Benadryl capsules, Benzedrine Sulfate tablets, one sale of Dexedrine Sulfate
tablets, and one sale of phenobarbital tablets, failed to bear the common or
usual names of the drugs.
Further misbranding, Section 502 (d), the phenobarbital tablets were drugs
for use by man and contained a chemical derivative of barbituric acid, which
derivative has been, by the Administrator of the Federal Security Agency,
found to be, and by regulations designated as, habit forming; and the labels
of the repackaged tablets failed to bear the name, and quantity or proportion
of such derivative and in juxtaposition therewith the statement "Warning-
May be habit forming."
DISPOSITION : November 28,1949. A plea of nolo contendere was entered by the
defendant. The defendant's attorney informed the court that he had advised
the defendant that such sales were not in violation of the law, and that the
defendant had acted on the advice of counsel in making the sales. Thereupon,
the court ordered the information dismissed.