OT:RR:NC:N3:138
Scott Maberry
Sheppard, Mullin, Richter & Hampton LLP
2099 Pennsylvania Avenue NW, Suite 100
Washington, DC 20006
RE: The country of origin of EXPAREL® (bupivacaine liposome injectable suspension)
Dear Mr. Maberry:
In your letter dated July 23, 2025, on behalf of Pacira Biosciences, Inc., you requested a country of origin
ruling on EXPAREL (bupivacaine liposome injectable suspension). We apologize for the delay as the
information was submitted to our laboratory for analysis.
EXPAREL (bupivacaine liposome injectable suspension) is a medicinal preparation containing bupivacaine
phosphate, an amide local anesthetic, as the active ingredient. It is a single-dose long acting local anesthetic
administered at the time of surgery to produce postsurgical local analgesia via infiltration in patients aged 6
years and older and regional analgesia in adults via an interscalene brachial plexus nerve block, sciatic nerve
block in the popliteal fossa, or an adductor canal block.
In your letter, you stated the active pharmaceutical ingredient (API), bupivacaine phosphate is made in the
United Kingdom (UK). In the UK, raw bupivacaine base is imported and reacted with phosphoric acid
sourced from the United States to become bupivacaine phosphate, which is then encapsulated within
multivesicular liposomes and formulated to produce the final bupivacaine liposome injectable suspension in
dosage form. According to our laboratory, the raw bupivacaine base transforms into bupivacaine phosphate
through a neutralization reaction.
When determining the country of origin, the substantial transformation analysis is applicable. See, e.g.,
Headquarters Ruling Letter (“HQ”) H301619, dated November 6, 2018. The test for determining whether a
substantial transformation will occur is whether an article emerges from a process with a new name,
character, or use different from that possessed by the article prior to processing. See Texas Instruments Inc. v.
United States, 681 F.2d 778 (C.C.P.A. 1982). This determination is based on the totality of the evidence. See
National Hand Tool Corp. v. United States, 16 C.I.T. 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993).
In this case, we find the processing of the raw Bupivacaine into the Bupivacaine Phosphate results in a
substantial transformation and the country of origin of EXPAREL (bupivacaine liposome injectable
suspension) will be the United Kingdom, where the API is made.
The holding set forth above applies only to the specific factual situation and merchandise description as
identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations
(CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the
information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and
complete in every material respect. In the event that the facts are modified in any way, or if the goods do not
conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and
Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2.
Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic
verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection
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, please contact
National Import Specialist Judy Lee at [email protected].
Sincerely,
(for)
James P. Forkan
Director
National Commodity Specialist Division