2693. Misbranding of Seconal sodium pulvules. U. S. v. Eeene Pharmacal Co.
(Harold Lloyd's Prescriptions), and Harold A. Lloyd, John M. Hilsher,
and Percy L. Stogsdill. Pleas of nolo contendere. Corporation fined
$200 on count 1 and total of $500 on counts 2 to 6; payment of $500 sus-
pended and corporation placed on probation for 1 year. Each individual
defendant fined $100. (F. D. C. No. 25594. Sample Nos. 22376-K, 22378-
K, 22379-K, 22381-K, 22384-K, 22386-K.)
INFORMATION FILED : January 26, 1949, Northern District of Texas, against the
Keene Pharmacal Co., a corporation, commonly known as Harold Lloyd's
Prescriptions, Dallas, Tex., and against Harold A. Lloyd, president of the cor-
' 'poration, and Percy L. Stogsdill and John M. Hilsher, pharmacists.
INTERSTATE SHIPMENT : Between the approximate dates of January 28 and Feb-
ruary 14,1948, from Indianapolis, Ind., to Dallas, Tex., of quantities of Seconal
sodium pulvules.
LABEL, WHEN SHIPPED : "Pulvules Seconal Sodium 1? grs. (0.1 Gm.) * * *
Eli Lilly And Company   Indianapolis."
ALLEGED VIOLATION : On or about March 3, 5, 9, 15, 19, and 22, 1948, while the
drug was being held for sale after shipment in interstate commerce, the defend-
ants caused a number of pulvules of the drug to be removed and to be repacked /
in boxes and caused them to be sold to various persons without a physician's
prescription, which acts of the defendants resulted in the drug being misbranded.
The repacked Seconal sodium pulvules were labeled in part "Harold Lloyd's
Prescriptions * * * No. 378919 Dr. Prejean * * * One each night
before retiring [or "One capsule each night before retiring" or "Take one
capsule each night before retiring"]."
NATURE OF CHARGE: Misbranding, Section 502 (d), the article was a drug for
use by man and contained a chemical derivative of barbituric acid, which
derivative has been found by the Administrator of the Federal Security Agency,
after investigation, to be and by regulations designated as, habit forming, and
the label of the repacked pulvules failed to bear the name and quantity or
proportion of such derivative and, in juxtaposition therewith, the statement
"Warning-May be habit forming"; Section 502 (f) (i), the labeling of the
repacked pulvules failed to bear adequate directions for use since the direc-
tions for use on the labeling quoted above for the repacked pulvules were not
adequate; and, Section 502 (f) (2), the repacked pulvules bore no labeling
containing warnings against use in those pathological conditions and by
children where their use may be dangerous to health, and against unsafe dosage
and methods and duration of administration.
DISPOSITION : January 27, 1949. Pleas of nolo contendere having been en-
tered, the court imposed against the corporation a fine of $200 on count 1 and
a total fine of $500 on counts 2 through 6, with payment of the $500 fine to
be suspended, and placed the corporation on probation for 1 year. The court
imposed also a fine of $100 against each of the individual defendants.