IA#61-01,
This revision updates information and reformats the text of the
alert which issued 9/17/82.
TYPE OF ALERT: Automatic Detention
PRODUCT : Gerovital, also known as KH3, GH3, Procaine
Hydrochloride (HCL), Trofibial H3, Aslavital,
Zell H3
PRODUCT CODE : 66V--99
HARMONIZED
CODE : 2933
PROBLEM : New Drug without an Approved New Drug
Application
(NDA)(DRND)
PAC FOR
DETENTION : 56008H
COUNTRY : All
MANUFACTURER/
SHIPPER : All
MANUFACTURER/
SHIPPER I.D.#: N/A
IMPORTER'S
I.D. # : N/A
CHARGE : "The article is suject to refusal of admission
pursuant to Section 801(a)(3) in that it
appears to be a new drug within the meaning of
201(p), without an approved new drug
application [Unapproved New Drug, Section
505(a)]."
REASON FOR
ALERT : Gerovital (KH3) which generally consists of
some form of Procaine HCL is regarded as a new
drug for all indications when offered for the
conditions for which it was found effective
under DESI 763. It requires an approved
Abbreviated New Drug Application (ANDA) for
legal marketing.
These products are frequently accompanied by
promotional literature or labeled as a
cure-all for such ailments as old age,
premature graying of hair, wrinkling of skin,
mental disorders, insomnia, decreased sexual
vigor, rheumatism, arthritis, heart problems,
depression, etc.
Products frequently enter the United States
through the mail and may be labeled as "Free
Trial Medical Samples."
Review of FY90-FY92 detention data indicated
that shipments of these products continue into
the United States from various areas.
Commercial size shipments have been noted
from:
- Francois J. Borking and Rogier Borking
Vinkeveen, Netherlands
- Life Extension, Richmond, British
Columbia, Canada
- Drug Faite, and I.C.E. Chima, Bucharest,
Romania
- L. Lobeck & R. Schmid, Zurich, Switzerland
- Zita Dros, Antwerp, Belgium
- M. Jose Fernandez, Madrid, Spain
- Farmatalia Carlo Erb., Pepetua De Magada,
Spain
RECOMMENDING
OFFICE : CDER, Office of Compliance, HFD-300 and
Division of Import Operations & Policy,
HFC-170
INSTRUCTIONS : Automatically detain:
- All products offered for entry as
Gerovital, GH3, KH3, Zell H3, GH3, GH3
Cream, etc.
- All commerical entries of finished
injectable and oral dosage forms of
Procaine Hydrochloride unless it is the
subject of an approved NDA/ANDA.
- All bulk Procaine Hydrochloride unless it
is being shipped to firms holding
approved NDA/ANDA's or is otherwise
permitted to be obtained for research or
teaching purposes. If shipments are
consigned to drug brokers, assurance
should be provided that the material is
destined for firms or individuals meeting
the criteria cited above (i.e., holders
of approved NDA/ANDA's, etc.).
- Questions should be directed to the
Center for Drug Evaluation and Research,
Health Fraud Staff (HFD-304) at (301)
295-8070.
PRIORITIZATION
GUIDANCE : N/A
FOI : No purging is required
KEYWORDS : Gerovital, KH3, GH3, Aging, Fraud, Procaine
HCL
PREPARED BY : Linda Wisniowski, DIOP, 301-443-6553.
|
