21591. Adulteration and misbranding of tincture belladonna and ointment 
of mercuric nitrate. 17. S. v. Standard Pharmaceutical Corpora- 
tion. Plea of guilty. Fine, S20 and costs. (F. & D. no. 29365. 
Sample nos. 8792-A, 8817-A.)
This case was based on an interstate shipment of tincture of belladonna rep- 
resented to be of pharmacopoeial standard, which was found to contain alka- 
loids of belladonna leaves in excess of the maximum prescribed in the United 
States Pharmacopoeia for tincture belladonna; also of a shipment of ointment 
of mercuric nitrate, represented to be of National Formulary standard, but 
which was found to contain less mercuric nitrate than prescribed in the 
National Formulary for ointment of mercuric nitrate.
On September 20, 1933, the United States attorney for the District of Mary- 
land, acting upon a report by the Secretary of Agriculture, filed in the district 
court an information against the Standard Pharmaceutical Corporation, Balti- 
more, Md., alleging shipment by said company in violation of the Food and 
Drugs Act, on or about April 6, 1932, from the State of Maryland into the 
District of Columbia, of a quantity of tincture of belladonna, and on or about 
May 27, 1932, from the State of Maryland into the State of Pennsylvania, of 
a quantity of ointment of mercuric nitrate, which products were adulterated 
and misbranded. The articles were labeled in part: " Tincture Belladonna 
(Tinctura Belladonnae) U.S.P. * * * Standard:—0.027 gm. to 0.033 gm. 
Alkaloids in 100 mils.", " Ointment of Mercuric Nitrate (Ung. Hydrarg. Nit. 
N.F. (U.S.P. It) Citrine Ointment * * * Standard Pharmaceutical 
Corp. Baltimore, Md."
Adulteration of the tincture of belladonna was alleged in the information 
for the reason that the article was sold under 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 the said pharmacopoeia 
official at the time of investigation, since it yielded not less than 0.03657 gram 
of the alkaloids of belladonna leaves per 100 cubic centimeters, whereas the 
pharmacopoeia provides that tincture of belladonna shall yield not more than 
0.033 gram of the alkaloids of belladonna leaves per 100 cubic centimeters and 
the standard of strength, quality, and purity of the article was not declared on 
the container. Adulteration of the ointment of mercuric nitrate was alleged 
for the reason that it was sold under a name recognized in the National For- 
mulary and differed from the standard of strength, quality, and purity as 
determined by the tests laid down in the said formulary official at the time of 
investigation in that it contained less than 7 percent of mercury, namely, not 
more than 5.13 percent of mercury, whereas the Formulary provides that oint- 
ment of mercuric nitrate shall contain not less than 7 percent of mercury, and 
the standard of strength, quality, and purity of the article was not declared on 
the container. Adulteration was alleged with respect to both products for the 
further reason that they fell below the professed standard and quality under 
which they were sold.
Misbranding was alleged for the reason that the statements, "Tincture 
Belladonna * * * U.S.P. * * * Standard 0.027 gm. to 0.033 gm. Al- 
kaloids in 100 mils" and "Ointment of Mercuric Nitrate * * * N.F.", 
borne on the labels of the respective articles, were false and misleading in that 
the said statements represented that the tincture of belladonna conformed to 
the standard laid down in the United States Pharmacopoeia and contained not 
more than 0.033 gram of alkaloids, and. that the ointment of mercuric nitrate 
conformed to the National Formulary,whereas the former was not of pharma- 
copoeial standard, each 100 mils containing more than 0.033 gram of alkaloids, 
and the latter did not conform to the tests laid down in the National 
Formulary.
On September 22, 1933, a plea of guilty to the information was entered on 
behalf of the defendant company, and the court imposed a fine of $20 and 
costs.
M. L. WILSON, Acting Secretary of Agriculture.