CBP to Begin Enforcing Origin Labeling on Prescription Medication Sold by Retail Pharmacies
CBP expects to start enforcing regulations requiring retail pharmacies to disclose the country of origin on the bottles of prescription medication meant for private individuals, according to comments made during the agency’s April 15 webinar on marking prescription medications.
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“Right now, we’re moving on to enforcement of everything we’ve talked about,” said a CBP official who is involved. The agency has moved on from educating the trade on the regulatory change to enforcing it, following guides that have been published on CBP’s website (see 2409100007) as well as webinars for the trade hosted by CBP.
As a result of a June 14 ruling letter issued by CBP’s Pharmaceuticals, Health and Chemicals Center of Excellence and Expertise (see 2408140037), prescription medication sold in retail pharmacies must have the medication’s country of origin marked on the bottle so that the ultimate purchaser, the last private individual receiving the medication, may know the country of origin of the product.
The regulation also calls for importers of prescription medication to provide a certificate of marking by the importer to the center director when they import prescription medications, and the importer must also inform the retail pharmacy or distributor that the medication is imported.
The retail pharmacy or distributor must then ensure that the country of origin is marked on the bottle. The marking must be conspicuous, legible and permanent, according to a CBP official speaking on the webinar.
“The ruling letter is clarifying already existing laws and regulations. There is nothing new here,” the CBP official said.
If the certification is not available, a bond must be filed, which the center director has discretion to reject, according to another official who works with CBP’s Centers of Excellence and Expertise.
The ruling also pertains to prescription medications sold at a retail pharmacy versus use in a long-term care facility or through clinical trials, according to CBP officials.