4145. Misbranding of penicillin G potassium tablets and sulfadiazine tablets.
U. S. v. Theodore M. Douglas and William H. Evans. Pleas of nolo con-
tendere. Fine of $50 against Defendant Douglas and $100 against De-
fendant Evans, plus costs. (F. D. C. No. 33844. Sample Nos. 33535-L,
33550-L, 33562-L.)
INFORMATION FILED: February 18, 1953, Northern District of Illinois, against
Theodore M. Douglas, a pharmacist, and William H. Evans, an employee of
the Star Drug Store, at Chicago, 111.
ALLEGED VIOLATION : On or about October 4 and 18, 1951, while a number of
penicillin G potassium tablets were being held for sale at the Star Drug
Store, after shipment in interstate commerce, each defendant caused a number
of such tablets to be dispensed in the original containers in which the tablets
had been shipped in interstate commerce, without the prescription of a physi-
cian, which acts resulted in the tablets being misbranded; and, on or about
October 20, 1951, while a number of sulfadiazine tablets were being held for
sale at the Star Drug Store, after shipment in interstate commerce, Defendant
Evans caused a number of such tablets to be repacked and dispensed without
a physician's prescription, which acts resulted in the repackaged tablets being
misbranded.
NATURE OF CHARGE : Penicillin O potassium tablets. Misbranding, Section 502
(f) (1), the labeling of the tablets failed to bear adequate directions for use.
(The containers in which the tablets were shipped in interstate commerce bore
no directions for use since they were exempt from such requirement by the
label statement "Caution: To be dispensed only by or on the prescription of
a physician." The act of the defendants in dispensing the tablets without a
physician's prescription, however, caused the exemption to expire.)
Sulfadiazine tablets. Misbranding, Section 502 (b) (1) and (2), the re-
packaged tablets failed to bear a label containing the name and place of
business of the manufacturer, packer, or distributor, and an accurate state-
ment of the quantity of the contents; Section 502 (e) (1), the repackaged
tablets failed to bear a label containing the common or usual name of the drug;
and, Section 502 (f) (1) and (2), the repackaged tablets failed to bear label-
ing containing adequate directions for use and 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 administra-
tion, in such manner and form, as are necessary for the protection of users.
DISPOSITION : June 12,1953. The defendants having entered pleas of nolo con-
tendere, the court imposed a fine of $50 against Defendant Douglas and $100
against Defendant Evans, plus costs.