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NY C85112

March 27, 1998

CLA-2-30:RR:NC:2:238 C85112


TARIFF NO.: 3004.39.0050; 9018.31.0090

Peter A. Martin, Esq.
Ross & Hardies
888 Sixteenth Street, N.W.
Washington, D.C. 20006-4103

RE: The tariff classification and country of origin marking of LUPRON DEPOT 7.5 mg (leuprolide acetate for depot suspension) prefilled dual-chamber syringe; and the tariff classification of plastic plungers for syringes from Japan

Dear Mr. Martin:

In your letter dated March 2, 1998, on behalf of your client, TAP Pharmaceuticals Inc. ("TAP"), you requested a tariff classification ruling and a country of origin marking ruling. A sample was submitted with your request.

The submitted sample, LUPRON DEPOT 7.5 mg, consists of a disposable, prefilled dual-chamber syringe (with a 23 gauge needle) and a plastic plunger, which are put up together in a plastic container to form a single-dose administration kit. The plastic plunger is threaded at one end for screwing into the barrel of the syringe at the time of injection. The front chamber of the syringe contains LUPRON DEPOT 7.5 mg (leuprolide acetate for depot suspension), which is your client's trade name for a medicament, having the appearance of a white powder, containing 7.5 mg of leuprolide acetate as the active ingredient. Leuprolide acetate is a synthetic analog of Leuteinizing Hormone-Releasing Hormone (LH-RH), and is indicated for use in the treatment of advanced prostatic cancer. The second chamber contains a sterile diluent, which is necessary to make the LUPRON DEPOT suitable for injection. Depressing the plunger (after screwing into the syringe barrel) causes the contents of the two chambers to mix together and form a suspension, which is intended as a monthly intramuscular injection. As indicated in your letter, the syringe is discarded after its contents are injected into the patient.

The plastic container has a permanently affixed label bearing, inter alia, the following marking:

"Manufactured for
TAP Pharmaceuticals Inc., Deerfield, IL 60015 by Takeda Chemical Industries Ltd., Osaka, Japan 541"

You state in your letter that leuprolide acetate powder is manufactured in the United States and exported to Japan, where Takeda Chemical Industries ("Takeda") encapsulates the drug into sterile microspheres. When injected into the body, these microspheres release the leuprolide acetate over a period of one to four months. Takeda packages the sterile microspheres into the front chamber of the dual-chamber syringe, while the second chamber is filled with sterile diluent. The diluent and syringes are both produced abroad. The prefilled dual-chamber syringes will then be packaged in cartons, along with the plastic plungers (which will be loosely packed in plastic bags separately), for shipment to the United States. TAP will perform the final packaging and labeling operation in the United States, and the finished product will be marketed and distributed under its registered trademark, LUPRON DEPOT .

You also indicate in your letter that, in certain instances, TAP will import "excess" plungers, in separate shipments, which do not accompany dual-chamber prefilled syringes, and request this office to rule on the tariff classification of such "excess" plastic plungers.

The applicable subheading for the LUPRON DEPOT 7.5 mg prefilled dual-chamber syringes, accompanied by its plastic plunger, will be 3004.39.0050, 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: 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 plastic plungers imported in separate shipments (i.e., which do not accompany the dual-chamber prefilled syringes) will be 9018.31.0090, HTS, which provides for: "Syringes, with or without needles; parts and accessories thereof: Parts and accessories." The rate of duty will be 1.7 percent ad valorem.

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) 443-6553.

You assert in your letter that the purpose of microencapsulating the leuprolide acetate is only to modify the delivery rate of the drug into the body from the daily-dosage form. Furthermore, you assert that the leuprolide acetate is not chemically altered by the microencapsulation process, and that the physiological action of the microencapsulated version is identical to that of the non-microencapsulated leuprolide acetate marketed by TAP in the daily injectable form of this medication. Therefore, you claim, only the form of the drug is altered. Absent any evidence to the contrary, we agree.

You also assert, citing HQ 557534, HQ 559136, HQ 733248, et al., that the LUPRON DEPOT imported by TAP is not a result of the substantial transformation of the U.S.-produced leuprolide acetate, since the leuprolide acetate has not lost its "identity" by undergoing microencapsulation, and, therefore, has not become an article "having a new name, character or use." On the basis of the information submitted, and the above-cited ruling letters, we agree that the processing of the leuprolide acetate in Japan [i.e., microencapsulation, mixing the microspheres with certain excipients (inert ingredients), and filling the front chamber of the syringe with a specified quantity of that mixture] does not result in a substantial transformation. We find that the fundamental character of the leuprolide acetate remains unchanged by this processing, which, in fact, serves to make the product marketable, since it can now be administered, in conjunction with the sterile diluent housed in the second chamber, by means of the dual-chamber syringe. Therefore, we find that the country of origin of the LUPRON DEPOT 7.5 mg is the U.S., and that the country of origin marking requirements under 19 U.S.C. 1304 do not apply to the LUPRON DEPOT 7.5 mg.

With respect to the marking requirements for the syringe, we agree that, for the reasons enunciated in HQ 559136, the syringe in which the LUPRON DEPOT 7.5 mg is housed (including the plastic plunger) is a "disposable container", as defined in 19 CFR 134.24(d), and therefore does not have to be marked with its own country of origin.

Finally, in light of our findings that neither the LUPRON DEPOT 7.5 mg nor the disposable syringe are required to be marked, we also agree that the appearance of the name and address of your client (i.e., Tap Pharmaceuticals Inc., Deerfield, IL 60015) on the permanently affixed label does not trigger the requirements of 19 CFR 134.46, since " ... the U.S. reference on the label is not the name of a locality other than the country or locality in which the article was manufactured or produced." HQ 559136.

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 212-466-5770.


Robert B. Swierupski

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