California-based drugmaker Carlsbad Technology requested a final determination concerning the country of origin of its Acyclovir tablets in July, and earlier this month the CBP responded.
The product “is not substantially transformed in US,” the Agency said in a letter to Carlsbad filed with the Federal Register last week, and “accordingly, the country of origin for government procurement purposes of the Acyclovir tablets is China and India, where the active ingredient is produced.”
US Government procurement
While the CBP determines the country of origin for drugs, it is not – according to spokesperson Katrina Skinner - directly responsible for the US Government’s procurement of such products.
“However, to the extent that the Trade Agreement Act generally requires that end products be acquired from the United States or designated countries - which China and India are not - then the drugs manufactured as described would not be eligible for sale to the US Government,” she told in-Pharmatechnologist.com.
“On the private market, the decision should not have a substantial impact, as this has been CBP's longstanding position, and it will require the end product to be labeled to indicate its country of origin, which is either India or China.”
The final determination filing only concerns the specific product that was being considered, i.e. Carlsbad’s Acyclovir, but “it has been CBP's position for many years that the country of origin of a pharmaceutical drug is the country where its active ingredient was made,” Skinner said.
“Making the drug into a pill form or into some other form which allows it to be taken for human consumption is not a substantial transformation.”
CBP’s requirements differ from those of the US Food and Drug Administration (FDA) which requires drug labels to “bear conspicuously the name and place of business of the manufacturer, packer, or distributor,” but defines manufacturer as one who “performs all of the following operations that are required to produce the product:”
“(1) Mixing, (2) granulating, (3) milling, (4) molding, (5) lyophilizing, (6) tableting, (7) encapsulating, (8) coating, (9) sterilizing, and (10) filling sterile, aerosol, or gaseous drugs into dispensing containers.”
In this specific case, the Acyclovir API is made in China and India and shipped to the third-party manufacture and distributor (CDMO) Carlsbad which makes the finished product in five stages from its Californian facility:
Firstly it sizes the active and inactive ingredients by passing them through a sieve. It then de-lumps the ingredients and granulates them with a binding suspension of corn starch. The third stage is the preparation of the tablet blend, before tablet compression followed by packaging in high density polyethylene plastic bottles for distribution in the US.
Carsbad did not respond when contacted by this publication.