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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
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| 07 May 2014 | By Alexander Gaffney, RAC
A proposed rule issued by the US Food and Drug Administration (FDA) would make it easier for the agency to destroy low-value drugs refused admission into the US under federal law.
The backbone of pharmaceutical regulation in the US is the Federal Food, Drug and Cosmetic Act (FD&C Act).
Under Section 801(b) of the FD&C Act, FDA is permitted to refuse to allow the import or entry of any drug that has not been approved (under Section 505a of the FD&C Act) in the US.
However, this law typically requires FDA to either turn the product away or to subject it to administrative detention procedures. For example, an unapproved drug that needed minimal further processing would be detained until it could be processed into its approved form.
This detention provision allows for FDA to prevent a drug from entering US commerce, but also permits an individual or company to appeal FDA's decision and re-obtain their drugs.
But what happens when the "importer" isn't a large and established pharmaceutical company, but is instead an individual or a small company importing just a few thousand dollars in unapproved pharmaceutical product?
FDA explains in its Federal Register notice that the majority of drugs imported into the US in small-value amounts come into the US through the postal service and are screened by US Customs and Border Protection (CBP). FDA estimates that between 20 and 100 million parcels imported into the US each year contain drugs, most of which originate from Internet pharmacies of questionable repute.
And plenty of those imports don't contain legal drugs, FDA explained, citing some of its import inspection efforts. The problem, it said, is that based on the volume of incoming mail, it is "extremely difficult to interdict all incoming shipments of violative drugs."
FDA said it's particularly concerned about misbranded dietary supplements and counterfeit drugs entering the US, since both can adversely affect consumer health.
So what's the problem? Under existing rules, even if a misbranded or counterfeit drug is detained at the point of import, its sponsor can apply to have the drug returned to him/her within 90 days, preventing FDA from destroying it.
That sponsor can then re-send the drug to the US for import, raising the chances that it will slip past inspection authorities.
"There is currently little deterrence to prevent sellers from sending violative drugs or resending previously refused drugs into the United States," FDA explained. It is, to borrow an example, as if the border patrol were required to return cocaine seized at a border crossing to the crime syndicate from which it originated.
FDA said the practice is so ridiculous that some refused drugs have actually been re-sent to the US in the same packaging, bearing the same sticker indicating prior FDA refusal.
Under a new rule proposed by FDA, this practice would be done away with.
Thanks to new authority granted to it under Section 708 of the Food and Drug Administration Safety and Innovation Act (FDASIA), FDA is now claiming the authority to destroy any drug refused entry without providing the owner or consignee of the drug with the opportunity to export the drug provided that the drug is valued at less than $2,500.
FDA would still provide the owner of the drug with written notice of FDA's intent to destroy the drug and an opportunity to present testimony to FDA, but the key change would be that it would no longer be re-exported if it was refused entry.
Proposed Rule: Administrative Destruction of Certain Drugs Refused Admission to the United States
Tags: Drug Import Regulation, Administrative Detention, 801a, FDASIA, Export, Import, Latest News