In June 2024, U.S. Customs and Border Protection (CBP) issued guidance on the marking requirements for prescription medications. Specifically, they determined that patients receiving prescription medications are the “ultimate purchaser” and thus the labeling on their medication must contain the country of origin. You can learn more about the details of this process by reading PHSL’s Viewpoints article from the Pharmacy Technology & Management Review July/August 2025 issue.

As reported in the article, in March 2025, multiple industry organizations submitted a letter to CBP requesting that the agency revoke or revise its ruling. The organizations submitted multiple arguments as to why the marking requirements were not valid and could not be completed by pharmacies, as listed below:

1. The Ruling Letter should be revoked because retail pharmacies—not the pharmacy customer to whom prescriptions are dispensed—are the “ultimate purchaser” for the purpose of COO marking.
2. The Ruling Letter should be revoked because compliance would hinder the ability of retail pharmacists to comply with complex federal and state statutory and regulatory requirements.
3. CBP’s requirement would require pharmacies to reconfigure their workflows and pharmacy technology systems – at an unsustainable cost.

On July 3, 2025, CBP responded to this request with a ruling affirming their position on the marking requirements. Below is a summary of their responses to the arguments presented above and quotes from the document explaining their justification of the ruling:

1. The patient receiving the medication is the ultimate purchaser, as stated in the initial ruling.
   1. “CBP has consistently held that repackaging does not result in a substantial transformation. Absent a substantial transformation, the last person in the United States who will receive the article in the form in which it was imported is the ultimate purchaser.”
   2. “While retail pharmacies do provide services, a survey of retail customers would indicate that the principal reason people go to a pharmacy is not to receive a service, but to buy a product, prescription medication. Prescription medication is sold at retail like many other products, such as non-prescription medication, cosmetics, food, clothing, etc., to name a few, and all of these products must be marked with their country of origin.”
2. Compliance with Country of Origin marking requirements will not hinder pharmacists’ ability to comply with state and federal laws and regulations, including the Drug Supply Chain Security Act (DSCSA).
   1. “Pharmacists, as Requesters explain, have the ability to provide the country of origin of prescription medication to customers upon request. As a result, we find the claim that pharmacists are unable to provide the country of origin without the DSCSA explicitly making it a requirement to do so, to be without merit, given that conveying this information to customers upon request is possible.”
   2. “…we trust that the country of origin marking clearly stated on the packaging of the prescription medications that retail pharmacies receive, will be adequate for pharmacies to convey the country of origin of prescription medication to their customers.”
   3. “Additionally, the country of origin does not necessarily have to be on the white space on the prescription label but can be included as a separate sticker.
3. Operational challenges are not a valid argument as to why pharmacies cannot comply with this requirement.
4. 1. 1. “While we understand the cost and challenges that may be incurred for adding the country of origin on prescription medication sold at retail, this is not an excuse to circumvent the law. Therefore, pharmacies are legally required to mark the country of origin on prescription medication regardless of the cost.”

CBP’s response suggests that for every prescription, a pharmacy can pull the country of origin from the stock bottle and enter it before generating the prescription label or a separate sticker. Anyone who has worked in a pharmacy knows that this is an unrealistic expectation. Pharmacies are often operating with limited staff under great pressure, and adding a manual step like this to the prescription process would not be sustainable. Pharmacies will ultimately need to rely on technological solutions. While some of CBP’s arguments are problematic, overall, CBP’s response suggests that pharmacies need to find a way to make this work because it is the law.

PHSL anticipates that this requirement will present operational obstacles resulting in compliance delays for pharmacies. Pharmacies should begin to consider the best course of action to comply with the requirement of including the country of origin on each medication dispensed. This may include developing internal resources while working with manufacturers and software vendors to create a process for compliance. If you need assistance in developing a process or understanding your company’s role in these requirements, contact PHSL for assistance.