H.R.3710 - To amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs.108th Congress (2003-2004)
|Sponsor:||Rep. Wexler, Robert [D-FL-19] (Introduced 01/20/2004)|
|Committees:||House - Energy and Commerce|
|Latest Action:||House - 02/03/2004 Referred to the Subcommittee on Health. (All Actions)|
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Summary: H.R.3710 — 108th Congress (2003-2004)All Information (Except Text)
Introduced in House (01/20/2004)
Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to promulgate regulations permitting pharmacists and wholesalers to import prescription drugs from Canada into the United States. Sets forth specified provisions respecting: (1) importer and foreign seller recordkeeping and information requirements; (2) qualified laboratory drug testing; (3) registration with the Secretary of Canadian sellers; and (4) approved labeling.
Declares that the Secretary should: (1) focus enforcement on cases in which individual importation poses a significant public health threat; and (2) exercise discretion to permit individuals to make such importation for non-risk personal use.
Authorizes the Secretary to grant individuals a waiver of the prohibition of importation of a prescription drug or device. Directs the Secretary to grant individuals a waiver of such prohibition for an approved prescription drug imported from Canada that is: (1) imported from a licensed pharmacy for not more than 90-day personal use; (2) accompanied by a valid prescription; (3) in a final finished dosage that was manufactured in a registered establishment; and (4) imported under such other conditions as the Secretary determines necessary to ensure public safety.