Summary
Save Our Seniors Act of 2003 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to permit pharmacists and wholesalers to import prescription drugs from Canada. Allows the Secretary to permit importation from European Union countries in three years if the Secretary finds that drugs imported from Canada have proven safe and effective.
Requires: (1) safeguards to ensure that each prescription drug imported is safe and effective; (2) importers to submit to the Secretary detailed information about the drug and shipment; (3) Canadian distributors to register with the Secretary; (4) immediate suspension of importation of a drug or by an importer if a pattern of counterfeiting or violations of this Act are discovered; and (5) manufacturers to authorize the use of the approved labeling for the drug.
Prohibits discrimination by manufacturers against wholesalers or pharmacists who distribute prescription drugs.
Declares that the Secretary should waive the prohibition against importation of a drug when it is clearly for personal use and does not present an unreasonable risk to the individual. Requires the Secretary to grant such waivers under certain circumstances and to publish guidance as to when the Secretary will grant these waivers.
Requires a study and report from: (1) the Institute of Medicine of the National Academy of Sciences on importation under this Act; and (2) the Comptroller General on the effect this section has on the retail price of prescription drugs.
Lifecycle of the Bill
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