US Codex
Bill
Notes

Title II — Ensuring a safe and secure supply of pharmaceuticals for the United States

S. 3683 · 116th Congress · May 11, 2020 · Lineage

II Ensuring a safe and secure supply of pharmaceuticals for the United States

201. Food and Drug Administration reporting requirements

(a)
In general— Not later than 180 days after the date of the enactment of this Act, and annually thereafter, the Commissioner of Food and Drugs shall submit to the appropriate congressional committees—
(1)
a list of all brand name and generic drugs and corresponding active pharmaceutical ingredients that the Commissioner determines are—
(A)
critical to the health and safety of United States consumers; and
(B)
are exclusively produced, or incorporate active pharmaceutical ingredients produced, in the People's Republic of China;
(2)
(A)
a certification that the pharmaceutical industry in the People's Republic of China is being regulated for safety, either by authorities of the Government of the People's Republic of China or by the Food and Drug Administration, to substantially the same degree as the United States pharmaceutical industry; or
(B)
if the Commissioner is unable to make a certification described in subparagraph (A), a plan to protect the people of the United States from unsafe or contaminated drugs manufactured in the People's Republic of China; and
(3)
a report on imports from the People’s Republic of China of all personal protective equipment that is intended for use as a medical device, including—
(A)
information on the percentage of demand in the United States for such equipment that is met by such imports; and
(B)
an analysis of the percentage of such imports that meet the standards of the Commissioner for use in the United States.
(b)
Appropriate congressional committees defined— In this section, the term appropriate congressional committees means—
(1)
the Committee on Finance and the Committee on Health, Education, Labor, and Pensions of the Senate; and
(2)
the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives.