H.R.147 - Prescription Drug Affordability Act
To amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs and the sale of such drugs through Internet sites.
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SECTION 1. SHORT TITLE.
SEC. 2. FACILITATION OF IMPORTATION OF DRUGS APPROVED BY FOOD AND DRUG ADMINISTRATION.
‘(d)(1)(A) A person who meets applicable legal requirements to be an importer of drugs described in subparagraph (B) may import such a drug (without regard to whether the person is a manufacturer of the drug) if the person submits to the Secretary an application to import the drug and the Secretary approves the application.CommentsClose CommentsPermalink
‘(B) For purposes of subparagraph (A), the drugs described in this subparagraph are drugs that are subject to section 503(b)(1) or that are composed wholly or partly of insulin.CommentsClose CommentsPermalink
‘(C) The Secretary shall approve an application under subparagraph (A) if the application demonstrates that the drug to be imported meets all requirements under this Act for the admission of the drug into the United States, including demonstrating that--CommentsClose CommentsPermalink
SEC. 3. INTERNET SALES OF PRESCRIPTION DRUGS.
‘(6)(A) With respect to the interstate sale of a prescription drug through an Internet site, the Secretary may not with respect to such sale take any action under this Act against any of the persons involved if--CommentsClose CommentsPermalink
‘(B) For purposes of subparagraph (A), the sale of a prescription drug by a person shall be considered to be an interstate sale of the drug through an Internet site if--CommentsClose CommentsPermalink
SEC. 4. REGULATIONS OF SECRETARY OF HEALTH AND HUMAN SERVICES; EFFECTIVE DATE.
(a) Regulations- Before the expiration of the period specified in subsection (b), the Secretary of Health and Human Services shall promulgate regulations to carry out the amendments to the Federal Food, Drug, and Cosmetic Act that are made by sections 2 and 3.CommentsClose CommentsPermalink
(b) Effective Date- The amendments to the Federal Food, Drug, and Cosmetic Act that are made by sections 2 and 3 take effect upon the expiration of the one-year period beginning on the date of the enactment of this Act, without regard to whether the regulations required in subsection (a) have been promulgated.CommentsClose CommentsPermalink