NCPA, along with the National Association of Chain Drug Stores, the Retail Industry Leaders Association, and the Healthcare Distribution Alliance, sent comments to U.S. Customs and Border Protection calling for it to revoke its letter H283420, dated June 17, 2024, which called for country-of-origin (COO) markings to be required for prescription drugs that are dispensed by pharmacies. Under CBP's ruling, medication bottles that pharmacies dispense to patients must be marked with the COO on the packaging that the patient receives.
The groups argued that CBP's letter should be revoked because retail pharmacies are the ultimate purchasers in the prescription drug supply chain; compliance with COO marking requirements would frustrate their ability to comply with federal and state statutory and regulatory requirements governing the dispensing of prescription drugs; and substantial investments would be necessary to reconfigure pharmacy workflows and technology systems.
NCPA and NACDS previously submitted joint comments to CBP in October 2024 and sent joint comments to the White House, Department of Health and Human Services, Food and Drug Administration, Department of Labor, and Department of Commerce leadership.
For a fact sheet on CBP's interpretive ruling, click here.
Additionally, CBP's Pharmaceuticals, Health and Chemicals Center is hosting a webinar on April 15 at 11 a.m. ET titled "Marking of Prescription Medications." The webinar will provide guidance and discuss the recent decision that requires country of origin marking for prescription medication for retail sale in the United States.
To register for this free webinar, click here. All registrants will receive the access link for the webinar the day before the event, but entry into the webinar is on a first-come, first-served basis as seats are limited. Other previously recorded webinars will be available for replay here. This webinar is a part of CBP's Continuing Education Program and will be worth one credit.
If you have any questions about this webinar, please contact [email protected].
