30976. Alleged adulteration and misbranding of Adrenapit (solution epinephrine 
chloride 1:1000), solution of pituitary extract, and suprarenals. V. S. 
v. Harvey-Pittenger Co. Tried to the court -without a jury. Judgment 
of not guilty.    (F. & D. No. 3973T.    Sample Nos. 8226-C to 8229-C, incl.)
Action was instituted in this case on the charge that the products failed to 
conform to the standard established by the United States Pharmacopoeia or by 
the National Formulary, and that their potency was below that declared on 
the labels.
On July 22, 1937, the United States attorney for the Eastern District of 
Pennsylvania, acting upon a report by the Secretary of Agriculture, filed in the 
district court an information against the Harvey-Pittenger Co., a corporation, 
Philadelphia, Pa., alleging shipment by said company in violation of the Food 
and Drugs Act on or about August 4,1936, from the State of Pennsylvania into 
the State of North Carolina, of quantities of the above-named drugs which were 
adulterated and misbranded.
The Adrenapit (solution epinephrine chloride 1:1000) was alleged to be 
adulterated in that it was sold under and by a name recognized in the United 
States Pharmacopoeia but differed from the standard of strength, quality, and 
purity as determined by the test laid down in the pharmacopoeia official at the 
time of investigation in that it contained not more than 67 percent of the 
potency required for solution of epinephrine hydrochloride prescribed in the 
pharmacopoeia and its standard of strength, quality, and purity was not 
declared on the container. It was alleged to be adulterated further in that its 
strength and purity fell below the professed standard of strength and quality 
under which it was sold in that it was represented to be solution of epinephrine 
chloride 1:1000; whereas it was not solution epinephrine chloride of the 
potency 1:1000. It was alleged to be misbranded in that the statements 
(carton and bottle), "Solution Epinephrin Chloride 1:1000 Physiologically 
Standardized. A * * * physiologically standardized solution of the isolated 
blood-pressure-raising principle of the suprarenal glands. Adrenapit is * * * 
A Potent, Uniform, Dependable Preparation," (booklet) "(Solution Epinephrine 
Chloride 1:1000) A * * * Potent, Uniform Dependable Standardized solu- 
tion of the blood-pressure-raising principle of the Suprarenal Gland * * * 
Adrenapit * * * Is a * * * solution of the isolated blood-pressure- 
raising principle of the suprarenal glands. * * * It is adjusted to a definite 
physiologic activity by its quantitative effect on the blood pressure of dogs as 
compared with a standard. * * * A potent, Uniform, Dependable, Prepara- 
tion. * * * it is of definite strength," were false and misleading since the 
article was not a solution of epinephrine chloride of strength 1:10CO, it was 
not physiologically standardized; it was not a physiologically standardized 
solution of the isolated blood-pressure-raising principle of the suprarenal 
glands, it was not a potent, uniform, dependable preparation, and it was not 
of definite strength, in that it was a preparation materially deficient in potency.
The solution of pituitary extract was alleged to be adulterated in that it 
was sold under a name recognized in the United States Pharmacopoeia but 
differed from the standard of strength, quality, and purity as determined by 
the tests laid down in the said pharmacopoeia in that 1 cubic centimeter 
of the article produced an activity upon the isolated uterus of the virgin 
guinea pig corresponding to less than 80 percent of that produced by 0.005 
gram of the standard powdered posterior pituitary, namely, an activity cor- 
responding to 45 percent of that produced by 0.005 gram of the standard 
powdered posterior pituitary; whereas the pharmacopoeia provides that 1 cc. 
of solution pituitary extract shall produce an activity upon the isolated uterus 
of the virgin guinea pig corresponding to not less than 80 percent of that pro- 
duced by 0.005 gram of standard powdered posterior pituitary. It was alleged 
to be misbranded in that the statements (carton and bottle), "Solution of Pitu- 
itary Extract.   A   *   *   *   solution of the extract of the posterior lobe of
the Pituitary Gland * * * Physiologically Standardized," and (carton only) 
"Specify Harvey-Pittenger * * * Highest Potency * * * Including 
* * * Physiologically Standardized * * * Endocrine Substances," were 
false and misleading in that the article was not solution of pituitary extract; 
was not a solution of the extract of the posterior lobe of the pituitary gland, 
was not physiologically standardized, was not of the highest potency, and 
did not include physiologically standardized endocrine substances, in that the 
article was a preparation materially deficient in potency.
The suprarenals were alleged to be adulterated in that they were sold under 
a name recognized in the National Formulary but differed from the standard 
of strength, quality, and purity as determined by the test laid down in said 
formulary in that they yielded less than 0.8 percent of epinephrine, namely, 
0.5 percent of epinephrine, equivalent to 5 milligrams in 1 gram of the article; 
whereas the National Formulary provides that suprarenal shall yield not less 
than 0.8 percent of natural epinephrine of glandular origin. They were alleged 
to be misbranded in that the statements, (carton and bottle) "Suprarenals 
Desiccated. One part represents about six parts of fresh glands. Physiologi- 
cally Standardized so that 1 gm. contains the equivalent of 10 mgm. 
Epinephrin" and "Uniform * * * preparations are assured by the appli- 
cation of every known chemical and biological method of Standardization," 
(carton) "Specify Harvey-Pittenger * * * Highest-Potency * * * In- 
cluding * * * Physiologically Standardized * * * Endocrine Sub- 
stances," were false and misleading in that the article was not suprarenals 
desiccated, one part thereof did not represent six parts of fresh glands, it was 
not physiologically standardized so that 1 gram contained the equivalent of 10 
milligrams of epinephrine, it was not standardized by every known chemical 
and biological method, it was not of the highest potency and did not include 
physiologically standardized endocrine substances, and in that it was a prepa- 
ration materially deficient in potency.
On December 18, 1939, a plea of not guilty having been entered on behalf 
of the defendant and a jury having been waived, the case came on for trial 
before the court. Evidence was introduced on behalf of the Government and 
of the defendant, at the conclusion of which the court entered a judgment of 
not guilty.
GROVER B. HILL, Acting Secretary of Agriculture.