Bill summaries are authored by CRS.

Shown Here:
Passed House without amendment (07/25/2003)

(This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)

Pharmaceutical Market Access Act of 2003 - (Sec. 4) Amends the Federal Food, Drug and Cosmetic Act to direct the Secretary of Health and Human Services to promulgate regulations allowing qualifying individuals to import covered products (in addition to pharmacists and wholesalers, whom current law authorizes to import such products).

Amends provision pertaining to record keeping regarding imported covered products. States that the Secretary shall not have to store records in cases in which qualifying individuals have imported a covered product.

Amends provisions regarding the importation of covered products, including to remove language directing the Secretary to require that a foreign seller specify the original source of the product and the amount of each lot of the product originally received.

Amends provisions regarding the testing of imported covered products. Declares that specified tests, including ones involving authenticity and degradation of products, shall not be required unless the importer is a wholesaler. Requires such tests to be conducted by the importer unless a product is a prescription drug subject to the provisions of this Act pertaining to counterfeit-resistant packaging. (Currently either the importer or the manufacturer may conduct such tests).

Eliminates the sunset date current law establishes for the provisions pertaining to the importation of covered products.

(Sec. 5) Classifies prescription drugs as misbranded if they do not incorporate specified counterfeit-resistant technologies in packaging.