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

CODE         :      2933

PROBLEM      :      New Drug without an Approved New Drug

DETENTION    :      56008H

COUNTRY      :      All

SHIPPER      :      All

SHIPPER I.D.#:      N/A

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

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

                    -    Francois J. Borking and Rogier Borking
                         Vinkeveen, Netherlands

                    -    Life Extension, Richmond, British
                         Columbia, Canada

                    -    Drug Faite, and I.C.E. Chima, Bucharest,

                    -    L. Lobeck & R. Schmid, Zurich, Switzerland

                    -    Zita Dros, Antwerp, Belgium

                    -    M. Jose Fernandez, Madrid, Spain

                    -    Farmatalia Carlo Erb., Pepetua De Magada,

OFFICE       :      CDER, Office of Compliance, HFD-300 and
                    Division of Import Operations & Policy,

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)
GUIDANCE     :      N/A

FOI          :      No purging is required

KEYWORDS     :      Gerovital, KH3, GH3, Aging, Fraud, Procaine

PREPARED BY  :      Linda Wisniowski, DIOP, 301-443-6553.