4488. Misbranding of whole ovarian substance, suprarenal cortex liquid, and
anterior pituitary substance. U. S. v. 14 Vials, etc (F. D. C. Nos.
37033,37034.    Sample Nos. 15941-L to 15944-L, incl.)
LTBEL FILED :   August 6,1954, Northern District of Oklahoma.?:
ALLEGED SHIPMENT : The suprarenal cortex liquid and the 14-vial lot of whole
ovarian substance were shipped by the Coast Chemical Co., from Los Angeles,
Calif., on or about February 9,1953, and June 21,1954. The anterior pituitary
substance and the 15-vial lot of whole ovarian substance were shipped by the
American Bio-Chemical Corp., from Los Angeles, Calif., on or about April 26
and June 25,1954.
PRODUCT : 14 vials and 15 vials of whole ovarian substance, 25 vials of suprarenal
cortex liquid, and 21 vials of anterior pituitary substance at Tulsa, Okla.
LABEL, IN PAET: (Vial) "30 cc Sterile Solution Whole Ovarian Substance
Each cc contains the water soluble extractives derived .from 80 grains of fresh
whole ovarian tissue. Chlorobutanol?0.5? Caution: To be dispensed only
by or on the prescription of a physician * * * Note: There is no scientific
evidence available that this product has therapeutic or physiological activity,"
"30 cc Sterile Solution Suprarenal Cortex Liquid Each cc contains the
extractives derived from 77? grains of fresh Suprarenal Cortex tissue.
Chlorobutanol?(as preservative) ?0.5? Caution: Federal law1 prohibits
dispensing without prescription * * * Intermuscular Injection No claims are
made for hormone activity," "Anterior Pituitary Substance Each cc contains
the water soluble extractives derived from 40 grains of fresh anterior pituitary
lobe. Chlorobutanol?0.5? Caution: Federal law prohibits dispensing with*
out prescription * * * For Intramuscular Use There is no scientific evidence,
available that this product has therapeutic or physiologic activity," "30 co
Sterile Solution Whole Ovarian Substance Each cc contains the water solu-
ble extractives derived from 40 grains of whole ovarian tissue. Chlorobu-
tanol?0.5? For Intramuscular Use Only Caution: Federal law prohibits
dispensing without prescription. Note: There is no scientific evidence avail-
able that this product has therapeutic or physiologic activity."
NATURE OF CHARGE: Misbranding, Section 502 (f) (1), the labeling of the ar-
ticles failed to bear adequate directions for use, and the articles were not en-
titled to any exemption from that requirement.
DISPOSITION : September 2,1954. Default decree of condemnation and destruc-
tion.
DRUGS FOR VETERINARY USE