NY 815340: The tariff classification of Sygen , imported in formulations put up in 50mg/2ml glass ampoules or 100mg/2ml glass ampoules, from Italy

Native CBP ruling rendition. Applicability is fact-specific; modification/revocation relationships and original publisher date are retained. Publisher sentinel year0001 means unknown date, not a historical legal adoption.

                            NY 815340
                              
                         October 16, 1995



CLA-2-30:R:N2:238 815340  

CATEGORY:  Classification

TARIFF NO.: 3004.90.9040  

Mr. Italo Mazzitti
Fidia Pharmaceutical Corporation
1401 Eye Street, N.W. - Suite 900
Washington, D.C.  20005 

RE:  The tariff classification of Sygen , imported in
     formulations put up in 50mg/2ml glass ampoules or 100mg/2ml
     glass ampoules, from Italy 

Dear Mr. Mazzitti:

     In your letter dated August 31, 1995, received by this
office on September 29, 1995, you requested a tariff
classification ruling.

     The subject products consist of formulations put up in glass
ampoules (50 mg/2ml ampoules or 100mg/2ml ampoules) containing
Sygen , chemically known as monosialotetrahexosylganglioside GM1
sodium salt, as the active ingredient.  You indicate in your
letter that Sygen  is currently undergoing clinical trials in the
United States and Canada for its ability to regenerate and/or
stimulate the growth of nervous tissue in cases of acute spinal
cord injury and Parkinson's disease. 

     The applicable subheading for the subject products will be
3004.90.9040, Harmonized Tariff Schedule of the United States
(HTS), which provides for: "Medicaments ... consisting of mixed
or unmixed products for therapeutic or prophylactic uses, put up
in measured doses or in forms or packings for retail sale: Other:
Other: Other: Medicaments primarily affecting the central nervous
system: Other."  The rate of duty will be free.

     This merchandise may be subject to the regulations of the
Food and Drug Administration.  You may contact them at 5600
Fishers Lane, Rockville, Maryland 20857, telephone number (301)
443-6553.   

     This ruling is being issued under the provisions of Section
177 of the Customs Regulations (19 C.F.R. 177).

     A copy of the ruling or the control number indicated above
should be provided with the entry documents filed at the time
this merchandise is imported.  If you have any questions
regarding the ruling, contact National Import Specialist C.
Reilly at 212-466-5770.



                                        Sincerely,




                                        Roger J. Silvestri
                                        Director,
                                        National Commodity
                                        Specialist Division