29271. Adulteration and misbranding of pituitary extract obstetrical. U. S. v. 
Sharp & Dohme, Inc. Plea of not guilty. Tried to the court. Judgment 
of guilty.    Fine, $50.   '(F. & D. No. 38646.    Sample No. 8122-C.)
This product when assayed in accordance with the test laid down in the 
United States Pharmacopoeia was found to possess a potency
' materially in 
excess of—in some instances, double—the potency prescribed by the pharma- 
copoeia for pituitary extract obstetrical.
On May 14, 1937, the United States attorney for the Eastern District of Penn- 
sylvania, acting upon a report by the Secretary of Agriculture, filed in the 
district court an information against Sharp & Dohme, Inc., trading at Phila- 
delphia, Pa., alleging shipment by said defendant in violation of the Food and 
Drugs Act on or about November 14, 1935, from the State of Pennsylvania into 
the State of New Jersey of a quantity of pituitary extract obstetrical which 
was adulterated and misbranded The article was labeled in part: "Sharp 
& Dohme Philadelphia—Baltimore."
The adulteration and misbranding charges appear in the court's opinion 
included herein.
On January 3, 1938, a plea of not guilty having been entered by the de- 
fendant, the case came on for trial before the court without a jury. The trial 
was continued from time to time and was concluded on June 17, 1938. On 
June 23, 1938, the court adjudged the defendant guilty and handed down the 
following opinion:
(MARIS, Judge) : Mathis is a criminal prosecution begun by information 
charging the defendant with violation of the Food and Drugs Act. The first 
count charged the introduction in interstate commerce of a drug labeled in part, 
'Pituitary Extract Obstetrical (10 International Units)' that was adulterated 
in that it was sold under and by a name recognized in the United States Phar- 
macopoeia and differed from the standard of strength as determined by the 
test laid down in the pharmacopoeia in that the drug possessed a potency of 
twice its labeled strength. The second count charged the Misbranding of the 
same drug in that the labeled statement, above-quoted, was false and mis- 
leading when applied to a drug possessing twice its labeled strength. A jury 
trial was waived by the parties. It was agreed that the drug seized by the 
Government had been introduced in interstate commerce by the defendant and 
the sole question raised at- the trial was whether it possessed a potency in 
excess of its labeled strength.
"The test laid down by the pharmacopoeia for assaying pituitary extract 
involved a comparison of the reaction to given quantities of standard pituitary 
powder and of the pituitary extract sought to be assayed of living muscle taken 
from the uterus of a virgin guinea pig and suspended in a nutrient solution. 
Such a biological assay is of course not nearly so exact in its results as a 
chemical analysis, since it depends for its success largely upon the character of 
the individual muscle used. However, while many of the individual tests prove 
inconclusive and unsatisfactory, it is nevertheless a fact that tests which are 
satisfactory are regularly obtained and may be readily identified as such. 
Such tests have been found in practice to give accurate results within a limit 
of 20 percent, plus or minus, and the procedure has been adopted as standard 
for testing this drug and it has been followed in practice for many years. The 
accuracy of this procedure was confirmed by a series of joint assays made with 
my approval of another specimen of defendant's product in the laboratories 
of the defendant and of the Food and Drug Administration at Washington.
"The pituitary extract here in question was labeled as having a strength of 
10 international units per cubic centimeter. This is the equivalent of 100 per- 
cent of standard. The extract which was seized by the Government was sub- 
jected to 15 assays by the Food and Drug Administration which showed an 
average strength of 186 percent of standard, the individual assays running from 
166 percent to 220 percent. A portion of the seized drug which was submitted 
by the Government to the defendant and subjected by it to four assays in its 
own laboratory showed results of 142 percent, 130 percent, 132 percent, and 
130 percent of standard, an average of 133.5 percent.
"As I have said, the prescribed test is generally considered valid within 
limits of 20 percent, plus or minus, and is so described in the pharmacopoeia. 
Pituitary extract assayed as not more than 120 percent of standard would 
accordingly be within allowable limits for extract stated to have a strength of 
10 international units. The evidence of both the Government and the defendant 
in this case, however, as I have indicated, shows beyond doubt, that the defend- 
ant's product here involved was substantially overstrength and far beyond the 
limits laid down in the pharmacopoeia. The conclusion is inescapable that the 
defendant is guilty of violating the Food and Drugs Act.
"In reaching this conclusion I have not overlooked the evidence of assays 
made by the defendant of samples taken at the time of manufacture from the 
batch of extract from which the product here in question is said to have been 
taken. I feel, however, the evidence of identity of the product assayed with 
that here involved is not sufficiently definite to overcome the direct evidence 
of the results of the later assays made upon the particular product involved in 
this prosecution. Nor do I think the evidence excludes the possibility that the 
product of which the Government complains was in fact surgical pituitary 
extract of the strength of 20 international units, which the defendant admit- 
tedly was manufacturing at about the same time and which may have been 
labeled '10 International Units' by mistake.
"Upon full consideration of all the evidence, I find the defendant guilty as 
charged in both counts of the information."
On June 29, 1938, a fine of $25 was imposed on each of the two counts of the 
information.
M. L. WILSON, Acting Secretary of Agriculture.