CLA-2:OT:RR:NC:N3:138
Ankit Patel
Granules Pharmaceuticals Inc.
3701 Concorde Parkway
Chantilly, VA 20151
RE: The country of origin of Butalbital, Acetaminophen and Caffeine Capsules, USP in dosage form
Dear Mr. Patel:
In your letter dated November 19, 2025, you requested a country of origin ruling on Butalbital,
Acetaminophen and Caffeine Capsules.
Butalbital, Acetaminophen, and Caffeine, imported in capsule form, is a medicinal preparation containing 50
mg of Butalbital (a barbiturate), 300 mg of Acetaminophen (an analgesic) and 40 mg of Caffeine (a
stimulant), as the active ingredients. It is indicated for the relief of symptoms associated with tension or
muscle contraction headaches.
You stated that the active pharmaceutical ingredients (APIs), Butalbital, Acetaminophen and Caffeine, are
manufactured in Belgium, India and China, respectively. The finished capsules in dosage form are
manufactured in the United States. In the United States, the Butalbital, Acetaminophen and Caffeine APIs
will be mixed with various inactive ingredients to produce the final capsules in dosage form.
Section 134.1(b), Customs Regulations (19 CFR 134.1(b)), defines "country of origin" as:
The country of manufacture, production or growth of any article of foreign origin entering the United States.
Further work or material added to an article in another country must effect a substantial transformation in
order to render such other country the "country of origin" within the meaning of this part; ….
A substantial transformation occurs when an article emerges from a process with a new name, character or
use different from that possessed by the article prior to processing. A substantial transformation will not
result from a minor manufacturing or combining process that leaves the identity of the article intact. See
United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (1940); and National Juice Products Association v.
United States, 628 F. Supp. 978 (Ct. Int’l Trade 1986).
In determining whether a substantial transformation occurs in the manufacture of chemical products such as
pharmaceuticals, CBP has consistently examined the complexity of the processing and whether the final
article retains the essential identity and character of the raw material. To that end, CBP has generally held
that the processing of pharmaceutical products from bulk form into measured doses does not result in a
substantial transformation of the product. See, e.g., Headquarters Ruling (“HQ”) 561975, dated April 3,
2002; HQ 561544, dated May 1, 2000; HQ 735146, dated November 15, 1993; HQ H267177, dated
November 5, 2016; HQ H233356, dated December 26, 2012; and, HQ 561975, dated April 3, 2002.
However, where the processing from bulk form into measured doses involves the combination of two or more
APIs, and the resulting combination offers additional medicinal benefits compared to taking each API alone,
CBP has held that a substantial transformation occurred. See, e.g., HQ 563207, dated June 1, 2005.
In this case, we note that the three separate APIs are mixed to create a combination drug that offers additional
medicinal benefits compared to taking each API alone. Therefore, we find the mixing of the active
ingredients, Butalbital, Acetaminophen and Caffeine, with the inactive ingredients into final dosage capsules
in the United States results in a substantial transformation and the country of origin will be the United States.
This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health
Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are
administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and
Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by
visiting their website at www.fda.gov.
This merchandise may also be subject to the Controlled Substances Act, which is administered by the U.S.
Drug Enforcement Administration (DEA), Office of Diversion Control. Information on the Controlled
Substances Act can be obtained by contacting the DEA at (800) 882-9539, or by visiting their website at
www.dea.gov.
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)
Evan Conceicao
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division