CBP Reaffirms Ruling Requiring Retail Pharmacies to Include Country of Origin on Medication Labels
CBP upheld its June 2024 ruling that the customer who buys the medication at retail -- not the retail pharmacy -- is the ultimate purchaser, and as a result, retail pharmacies must list the medicine's country of origin on the prescription label. This is the case even if the FDA's Drug Supply Chain Security Act doesn't require country of origin on the prescription label, according to CBP.
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"Given that Requesters have conceded that, if interested, retail customers can ask pharmacists for the country of origin of their medication, we fail to see how compliance with the internal advice decision will cause such an undue burden when retail pharmacies have the country of origin readily available to them on the packaging of the prescription medication they receive, and need only to take the additional step of providing the country of origin on the outside packaging of prescription medication sold to ultimate purchasers," CBP said in HQ H346255, dated July 3.
Four trade associations -- the National Association of Chain Drug Stores, the Retail Industry Leaders Association, the National Community Pharmacists Association and the Healthcare Distribution Alliance -- had asked CBP to reconsider its ruling from June 2024 (see 2408140037).
According to the ruling, the trade associations, dubbed requesters in the ruling, argued that the Drug Supply Chain Security Act (DSCSA) sees retail pharmacies and drug repackagers as having separate roles. In making the law, Congress also hadn't included country of origin information on the list of information that must be exchanged by trading partners in the prescription drug supply chain, the requestors said.
CBP also said the associations had argued that it would be impossible for dispensers to derive package-level country of origin details from the list of required information under the act and that the information about country of origin isn't critical.
But CBP countered, "We find these arguments to be unavailing," adding that the requesters hadn't provided any evidence or a single example that shows adherence to CBP's ruling would hinder the ability of retail pharmacies to comply with state or federal law.
"Requesters have simply argued that the DSCSA does not require this information. Although this may be true, CBP, not the FDA, is the agency that implements and enforces the marking statute," CBP said. "Furthermore, CBP is not bound by the rules and regulations of other agencies, and we found no conflict between FDA’s guidance and the holding in the internal advice. In fact, requiring the country of origin on prescription medication sold at retail furthers the objective of the DSCSA of protecting patient safety and preventing dangerous counterfeit medications sold at retail."
While the requesters argued that, since the country of origin is not on the list of information required by the DSCSA, it's impossible for dispensing pharmacies to derive country of origin information, CBP countered that that claim is "inaccurate because pharmacists, as Requesters explain, have the ability to provide the country of origin of prescription medication to customers upon request."
"It is inconsistent to argue that the country of origin needs to be added as a requirement under the DSCSA to accurately convey the country of origin of prescription medication, even though dispensing pharmacies are able to (and do, upon request) provide the country of origin of prescription medication to customers without this requirement," CBP said.
CBP also argued that giving the prescription purchasers the ability to know a medication's country of origin allows purchasers to make informed decisions, including whether to purchase medications made in certain countries.
"If every single product sold at retail in its imported form is marked with its country of origin ... we see no rationale as to why prescription medication should be exempted from complying with the country of origin ma[r]king laws and regulations," CBP said.
CBP had issued a fact sheet on the ruling last September (see 2409100007), saying that including the country of origin gives more information to the consumer and allows the consumer to be selective about purchasing certain products made in certain countries. It would also allow CBP to maintain commodity statistics of import volumes and allow U.S. manufacturers to analyze competition and track counterfeit goods.