CLA-2-30:RR:NC:2:238 F88863
Mark N. Bravin, Esq.
Dorothy J. Black, Esq.
Morgan, Lewis & Bockius, LLP
1800 M Street
Washington, D.C. 20036-5869
RE: The tariff classification of MYOTROPHIN® (mecasermin [recombinant DNA origin]) Injection, imported put up in single-dose vials; MYOTROPHIN® Injection, imported in bulk form; and Mecasermin (human insulin-like growth factor-1, human IGF-1) (CAS-68562-41-4), imported in bulk form, from Taiwan
Dear Mr. Bravin & Ms. Black:
In your letter dated June 16, 2000, on behalf of your client, Cephalon, Inc., you requested a tariff classification ruling.
The first product, MYOTROPHIN® (mecasermin [recombinant DNA origin]) Injection, is your client’s brand name for a medicament, imported put up in pre-packaged single-dose vials, containing Mecasermin (recombinant human insulin-like growth factor-1, human IGF-1) as the active ingredient. The product is indicated for the treatment of signs and symptoms associated with amyotrophic lateral sclerosis (ALS). In a telephone conversation with a member of my staff, on July 7, 2000, you indicated that Phase 3 clinical trials are pending for MYOTROPHIN®.
The second product, MYOTROPHIN® Injection, imported in bulk form, is identical in composition to the first product (see above), except that it will be imported in bulk form, rather than in pre-packaged single dose vials.
The third product, Mecasermin (human insulin-like growth factor-I, human IGF-1), is the nonproprietary name for the active ingredient of the first and second products described above. You state that it is produced by recombinant DNA technology, and is identical to naturally occurring human insulin-like growth factor 1 (human IGF-1).
In discussing the role of IGFs, Goodman & Gilman’s The Pharmaceutical Basis of Therapeutics, Ninth Edition, notes that the anabolic and growth-promoting effects of growth hormone “[a]re mediated indirectly by other hormones, collectively known as somatomedins or
insulin-like growth factors (IGFs) … . There are two IGFs, IGF-1 and IGF-2, which share homology with each other and with insulin and have insulin-like effects.“ Further, “[A]lthough many tissues can synthesize IGF-1 and IGF-2, the liver is considered to be the major source of circulating IGF-1.” ibid.
The applicable subheading for MYOTROPHIN® (mecasermin [recombinant DNA origin]) Injection, imported put up in single-dose vials, will be 3004.39.0050, Harmonized Tariff Schedule of the United States (HTS), which provides for "[M]edicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale: Containing hormones or other products of heading 2937 but not containing antibiotics." The rate of duty will be free.
The applicable subheading for MYOTROPHIN® Injection, imported in bulk form; will be 3003.39.5000, HTS, which provides for "[M]edicaments … consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale: Containing hormones or other products of heading 2937 but not containing antibiotics: Other: Other." The rate of duty will be free.
The applicable subheading for Mecasermin (human insulin-like growth factor-I, human IGF-1), imported in bulk form, will be 2937.99.9550, HTS, which provides for “[O]ther hormones and their derivatives; other steroids used primarily as hormones: Other: Other: Other.” The rate of duty will be free.
This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 301-443-1544.
This ruling is being issued under the provisions of Part 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 Harvey Kuperstein at 212-637-7068.
Sincerely,
Robert B. Swierupski
Director,
National Commodity
Specialist Division