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On August 18, 2017 signed into law the “FDA [Food and Drug Administration] Reauthorization Act of 2017” (H.R.2430). Section 604 of the bill amends the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)) to provide that, with certain exceptions, “no drug that is subject to section 503(b)(1) may be imported into the United States for commercial use if such drug is manufactured outside the United States, unless the manufacturer has authorized the drug to be marketed in the United States and has caused the drug to be labeled to be marketed in the United States.” Section 503(b)(1) concerns drugs that are “intended for use by man” that are “not safe for use except under the supervision of a practitioner licensed by law to administer such drug” or are “limited … to use under the professional supervision of a practitioner licensed by law to administer such drug.”
According to the committee in the House of Representatives that developed this bill, the provision is intended to protect and strengthen the drug supply chain. It is aimed at those who “illegally diver[t] drugs into the U.S. that were manufactured abroad and intended for foreign markets” by harmonizing the penalties with those imposed for “diverting drugs that were initially manufactured in the U.S.”
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