3181. Misbranding of methyl testosterone tablets.   U. S. v. Louis Needman
(West Coast Prescription Pharmacy).   Plea of nolo contendere.   Fine,
$50.    (F. D. C. No. 28204.    Sample Nos. 31524-K, 31527-K.)
INFORMATION FILED: March 27, 1950, Southern District of California, against
Louis Needman, trading as the West Coast Prescription Pharmacy, Los
Angeles, Calif.
INTERSTATE SHIPMENT: Between the approximate dates of December 22,
1948, and June 15, 1949, from the State of New Jersey into the State of Cali-
fornia.
ALLEGED VIOLATION : On August 4 and 8, 1949, while the drug was being held
for sale after shipment in interstate commerce, the defendant removed a
number of methyl testosterone tablets from the bottle in which they had been
shipped in interstate commerce and repacked them in a small bottle and sold
them without a prescription; also, on August 8, the defendant sold a number
of methyl testosterone tablets in the bottle in which they had been shipped
in interstate commerce, after first relabeling the bottle, and sold them without
a physician's prescripion, which acts of the defendant resulted in the re-
packaged and relabeled tablets of drug being misbranded.
NATURE OF CHARGE: Misbranding, Section 502 (j), the article was dangerous
to health when used in the dosage and with the frequency prescribed, rec-
ommended, and suggested in its labeling, in that each tablet contained 10
milligrams of methyl testosterone and the use of a drug containing 10 milli-
grams of methyl testosterone in each tablet with the frequency prescribed,
recommended, and suggested in the labeling, namely, as directed on the labels,
 "1-2 linguets daily" and "1-2 daily," would be dangerous to health since
such use of the article may result in sterility and would stimulate the growth
of carcinoma of the prostate gland; and, Section 502 (f) (1), the labeling
of the article failed to bear adequate directions for use in that there was no
statement in the labeling of any condition, disease, or function for which
the article was to be used.
DISPOSITION: May 22, 1950. A plea of nolo contendere having been entered,
the court imposed a fine of $50.