1163. Adulteration, and misbranding, of Phenolix Elixir Phenobarbital. TJ. S. v.
'Wayne Pharmacal Supply Co. Plea of nolo contendere. Fine, $50 and
costs.     (F. D. C. No. 9687.    Sample No. 584-F.)
On August 27, 1943, the United States attorney for the Northern District of
Indiana filed an information against the Wayne Pharmacal Supply Co., a cor-
poration, Fort Wayne, Ind., alleging shipment of a quantity of the above-named
product on or about November 10, 1942, from the State of Indiana into the State
of Michigan.
The article was alleged to be adulterated in that it purported to be a drug, the
name of which is recognized in the United States Pharmacopoeia, an official
compendium, but its quality or purity fell below the standard set forth therein
since the compendium provides that elixir of phenobarbital shall be a clear elixir
and shall contain not less than 12 percent of alcohol and 450 cc. of glycerin per
1,000 cc, whereas the article was not a clear elixir, but was a liquid containing a
large amount of precipitated, crystallized phenobarbital, and it contained not
more than 0.15 percent of alcohol and not more than 26 cc. of glycerin per
1,000 cc.
It was alleged to be misbranded in that it was for use by man and it contained
phenobarbital, a derivative of barbituric acid, a hypnotic substance, which
derivative has been, after investigation, found to be, and by regulations has been
designated as, habit-forming, and the label of the article did not bear the name and
quantity or proportion of such derivative and, in juxtaposition therewith, the
statement "Warning-May be habit forming."
On January 6, 1944, the defendant having entered a plea of nolo contendere,
the court imposed a fine of $25 .on each of 2 counts, plus costs.