3746. Misbranding of Donnatal tablets and sulfadiazine tablets.   U. S. v. Dew
berry Drug Co., Ltd., Milton Temerson, Walker N. Fricks, Grafton G.
Smith, and James O. Self. Pleas of nolo contendere. Fine of $50 against
each defendant. (F. D. C. No. 31287. Sample Nos. 75113-K, 752-L,
21403-L, 21424-L to 21426-L, incl.)
INFORMATION FILED : December 19, 1951, Northern District of Alabama, against
Dewberry Drug Co., Ltd., a partnership, Birmingham, Ala., and against Milton
Temerson, a partner in the partnership, and Walker N. Fricks, Grafton G.
Smith, and James O. Self, pharmacists for the partnership.
INTERSTATE SHIPMENT : From the States of Virginia and Missouri into the State
of Alabama, of quantities of Donnatal tablets and sulfadiazine tablets.
ALLEGED VIOLATION: On or about September 7, 1950, and January 17, March 8,
and May 5 and 7, 1951, while the drugs were being held for sale after ship-
ment 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.
The partnership and Milton Temerson were charged with causing the acts
of repacking and dispensing of the drugs involved in each of the 6 counts of the
information. In addition, Walker N. Fricks in 1 count, Grafton G. Smith
in 1 of the other counts, and James O. Self in 1 of the 2 other counts were
charged with causing the acts involved in those counts.
NATURE OF CHABGB: Misbranding, Section 502 (f) (1), the labeling of the re-
packaged drugs failed to bear adequate directions for use.
Further misbranding, Section 502 (b) (2), the repackaged sulfadiazine
tablets failed to bear a label containing an accurate statement of the quantity
of the contents.
Further misbranding, Section 502 (d), the repackaged Dormatal tablets
contained a chemical derivative of barbituric acid, phenobarbital, which
derivative has been found to be, and by regulations designated as, habit form-
ing ; and the label of the repackaged Donnatal 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 sulfadiazine
tablets failed to bear a label containing the common or usual name of the
drug; Section 502 (e) (2), the repackaged Donnatal tablets were fabricated
from two or more ingredients, and the label failed to bear the common or usual
name of each active ingredient; and, Section 502 (f) (2), the labeling of the
repackaged sulfadiazine tablets failed to bear such 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,
as are necessary for the protection of users.
DISPOSITION : January 10, 1952. Pleas of nolo contendere having been entered,
the court imposed a fine of $50 against each of the defendants.