27137* Adulteration and misbranding of No. 8 Dispensary Tablets Extract 
Belladonna Leaves, Powdered Extract Belladonna Leaves U. S. P. X, 
and No. 39 Opbtbalmlc Ointment Atropine Sulphate. U. S. v. Sharp 
& Dohme, Inc.    Plea of nolo contendere.    Sentence suspended.     (P. &
D. no. 38047.   Sample nos. 45419-B, 67509-B. 67569-B.)
The No. 8 Dispensary Tablets Extract Belladonna Leaves contained less 
than the quantity of extract of belladonna leaves represented on the label. The 
Powdered Extract Belladonna Leaves U. S. P. X differed from the standard 
prescribed for such article in the United States Pharmacopoeia and yielded 
less than the proportion of the total alkaloids of belladonna leaves represented 
on the label. The No. 39 Ophthalmic Ointment Atropine Sulphate contained 
less than the proportion of atropine sulphate represented on the label.
On December 28, 1936, 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 Sharp & Dohme, Inc., charging 
shipment by said corporation in violation of the Food and Drugs Act, on or 
about October 18, 1935, from the State of Pennsylvania into the State of 
Georgia of a quantity of No. 8 Dispensary Tablets Extract Belladonna Leaves; 
on or about February 20, 1936, from the State of Pennsylvania into the State 
of New Jersey of a quantity of Powdered Extract Belladonna Leaves U. S. P. 
X; and on or about January 11, 1936, from the State of Pennsylvania into the 
State of New Jersey of a quantity of No. 39 Ophthalmic Ointment Atropine 
Sulphate all of which products were adulterated and misbranded.
The article No. 8 Dispensary Tablets Extract Belladonna Leaves was alleged 
to be adulterated in that its strength and purity fell below the professed stand- 
ard and quality under which it was sold, in that each of the tablets was repre- 
sented to contain 1 grain of extract of belladonna leaves; whereas in fact 
each of the tablets contained not more than 0.78 grain of extract of belladonna 
leaves. Said article was alleged to be misbranded in that the statement, 
"Tablets Extract Belladonna Leaves 1-Grain", borne on the bottle labels, was 
false and misleading in that it represented that each of the tablets contained 
1 grain of extract of belladonna leaves; whereas in fact each of the tablets 
contained less than 1 grain of extract of belladonna leaves.
The article Powdered Extract Belladonna Leaves U. S. P. X was alleged to 
be adulterated in that it was sold under and by a name recognized in the United 
States Pharmacopoeia, and differed from the standard of strength, quality, 
and purity as determined by the test laid down in said pharmacopoeia in that 
1 gram of the article yielded less than 1.18 percent of the total alkaloids of 
belladonna leaves, to wit, not more than 1 percent of the total alkaloids of 
belladonna leaves; whereas said pharmacopoeia provided that powdered ex- 
tract of belladonna leaves should yield not less than 1.18 percent of the total 
alkaloids of belladonna leaves, and the standard of strength, quality, and 
purity of the article was not declared on the container thereof. Said article 
was alleged to be adulterated further in that its strength and purity fell below 
the professed standard and quality under which it was sold in that it was 
represented to be powdered extract of belladonna leaves that conformed to 
the standard laid down in the United States Pharmacopoeia, 10th Revision, 
and that 1 gram of the article yielded 1.18 to 1.32 percent of the total alkaloids 
of belladonna leaves; whereas in fact the article was not powdered extract 
of belladonna leaves which conformed to the standard laid down in said 
pharmacopoeia, and 1 gram of the article yielded less than 1.18 percent of the 
total alkaloids of belladonna leaves. Said article was alleged to be misbranded 
in that the statements, "Powdered Extract Belladonna Leaves U. S. P. X", and 
"One gram of this powdered extract * * * yields 1.18% to 1.32% total 
alkaloids", borne on the bottle labels, were false and misleading in that they 
represented that it was powdered extract of belladonna leaves that conformed 
to the standard laid down in the United States Pharmacopoeia, 10th Revision,
and that 1 gram of the article yielded 1.18 to 1.32 percent of the total alkaloids 
of belladonna leaves; whereas in fact the article was not powdered extract of 
belladonna leaves that conformed to the standard laid down in said pharma- 
copoeia, and 1 gram of the article yielded less than 1.18 percent of the total 
alkaloids of belladonna leaves.
The article No. 39 Ophthalmic Ointment Atropine Sulphate was alleged to 
be adulterated in that its strength and purity fell below the professed standard 
and quality under which it was sold, in that it was represented to contain 1 
percent of atropine sulphate; whereas in fact the article contained not more 
than 0.75 percent of atropine sulphate. Said article was alleged to be mis- 
branded in that the statement, "Ophthalmic Ointment Atropine Sulphate 1 
Per cent", borne on the tube labels, cartons, and boxes containing the cartons, 
was false and misleading in that it represented that the article contained 
1 percent of atropine sulphate; whereas in fact it contained less than 1 percent 
of atropine sulphate.
On March 19, 1937, the defendant entered a plea of nolo contendere and the 
court suspended sentence.
HARBT L. BROWN, 
Acting Secretary of Agriculture.