Summary: H.R.328 — 109th Congress (2005-2006)All Information (Except Text)

There is one summary for H.R.328. Bill summaries are authored by CRS.

Shown Here:
Introduced in House (01/25/2005)

Pharmaceutical Market Access Act of 2005 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to promulgate regulations permitting pharmacists, pharmacies, wholesalers, and individuals to import qualifying drugs from certain countries into the United States.

Sets forth registration requirements for exporters.

Requires the Secretary to: (1) educate consumers with regard to the availability of qualifying drugs for import for personal use; (2) inspect the facilities and records of importers and registered exporters to ensure compliance with this Act; and (3) establish a registration fee program to collect an annual fee from registered exporters.

Deems a prescription drug to be misbranded unless the packaging of such drug complies with the requirements for counterfeit-resistant technologies.

Prohibits: (1) failing to register in accordance with this Act; and (2) importing or offering to import a prescription drug in violation of a suspension order.

Declares that selling or importing a patented drug in the United States that was first sold abroad by or under authority of the owner or licensee of the patent is not patent infringement.

Prohibits drug manufacturers from discriminating against a person that engages in the importation of a prescription drug, including by charging higher prices or denying supplies of the drug.

Allows the Secretary to suspend or terminate the registration of an exporter for failing to maintain substantial compliance with all registration conditions.