Liability for Packaged Drug products Sold Indirectly in the International Market.

[erniel]

this item removed

[Helmut Jilling]

Originally Posted by erniel

I have just discovered the following scenario and need to know my liability.

We sell finished and packaged otc blister packaged drugs to a "customer". This customer in turn either resells, or in some cases, donates the products to international relief organizations that provide the packaged drugs to poor, homeless or other individuals who have a need.

Since I am the packager of the product what liability do i have with the FDA since my product, unknown to me, is being sold internationally.

Any help will be appreciated

I think if you want a real answer to this question, you need to consult an attorney knowledgeable about product liability and internal trade law. The Cove is not a reliable place to solicit legal advice.

[harry]

I can't speak of other countries but for mine, any drugs imported need approval from the local health authorities. It's much easier if there's FDA approval.

For a drug that's not approved locally, I don't think the user can come after the manufacurer who is not the importer. The best thay can do is to go after the importer for selling unapproved drugs.

[Ajit Basrur]

Under the Product Liability Law, primarily responsibility for the fault/defect rests with the manufacturer or the importer. If it is not possible to identify the manufacturer or importer of the product the Product Liability Law permits the claim to be brought against the distributor of the product or against any other person who has sold or otherwise distributed the product.

The latter shall be released from liability if it provides information on the manufacturer or importer of the product or on other person who has supplied the product to it.

But, as hjilling suggested, its better to refer to the attorneys as these laws differ from one country to another.