PROTECTING AND STRENGTHENING THE DRUG SUPPLY CHAIN.

SEC. 604. PROTECTING AND STRENGTHENING THE DRUG SUPPLY CHAIN. (a) Diverted Drugs.—Paragraph (1) of section 801(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)) is amended— (1) by striking “(d)(1) Except as” and inserting “(d)(1)(A) Except as”; and (2) by adding at the end the following: “(B) Except as authorized by the Secretary in the case of a drug that appears on the drug shortage list under section 506E or in the case of importation pursuant to section 804, 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.” . (b) Counterfeit Drugs.—Subsection (b) of section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the following: “(8) Notwithstanding subsection (a), any person who violates section 301(i)(3) by knowingly making, selling or dispensing, or holding for sale or dispensing, a counterfeit drug shall be imprisoned for not more than 10 years or fined in accordance with title 18, United States Code, or both.” .