IMPLEMENTATION LEVEL

National

AFFECTED FLOW

Inflow

ANNOUNCED AS TEMPORARY

No

NON-TRADE-RELATED RATIONALE

Yes

ELIGIBLE FIRMS

all

JUMBO

No

TARIFF PEAK

No
← back to the state act
Inception date: 18 Aug 2017 | Removal date: open ended
Still in force

Import ban

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.”

AFFECTED COUNTRIES

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TABLE
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AFFECTED SECTORS AND PRODUCTS

352 Pharmaceutical products
3001 Glands and other organs for organotherapeutic uses, dried, whether or not powdered; extracts of glands or other organs or of their secretions for organotherapeutic uses; heparin and its salts; other human or animal substances prepared for therapeutic or
300120 Extracts of glands or other organs or of their secretions
300190 Other
3002 Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micr
300210 Antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes
300220 Vaccines for human medicine
300290 Other
3003 Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale.
300310 Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycins or their derivatives
300320 Containing other antibiotics
300339 Other
300340 Containing alkaloids or derivatives thereof but not containing hormones or other products of heading 29.37 or antibiotics
300390 Other
3004 Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packin
300410 Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycins or their derivatives
300420 Containing other antibiotics
300431 Containing insulin
300432 Containing corticosteroid hormones, their derivatives or structural analogues
300439 Other
300440 Containing alkaloids or derivatives thereof but not containing hormones, other products of heading 29.37 or antibiotics
300450 Other medicaments containing vitamins or other products of heading 29.36
300490 Other

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