HR 1483

112th CONGRESS
1st Session

H. R. 1483

To amend the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

April 12, 2011

Mr. DINGELL (for himself, Mr. WAXMAN, Mr. PALLONE, and Ms. DEGETTE) introduced the following bill; which was referred to the Committee on Energy and Commerce


A BILL

To amend the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs, and for other purposes.

SECTION 1. SHORT TITLE.

SEC. 2. TABLE OF CONTENTS.

TITLE I--PREVENTION

TITLE II--RESPONSE

TITLE III--IMPORTATION AND EXPORTATION

TITLE IV--MISCELLANEOUS

TITLE I--PREVENTION

SEC. 101. REGISTRATION OF PRODUCERS OF DRUGS; APPLICABLE FEE.

`SEC. 736C. REGISTRATION FEE.

SEC. 102. DRUG SUPPLY QUALITY AND SAFETY.

`SEC. 503C. EFFECTIVE QUALITY SYSTEM FOR DRUG MANUFACTURERS.

SEC. 103. INSPECTION OF PRODUCERS OF DRUGS.

SEC. 104. PROHIBITION AGAINST DELAYING, LIMITING, OR REFUSING INSPECTION.

SEC. 105. CLARIFICATION OF INSPECTION AUTHORITY RELATED TO BIMO AND IRB INSPECTIONS.

SEC. 106. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED DRUG PRODUCTS.

`SEC. 568. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED DRUGS.

SEC. 107. NOTIFICATION.

`SEC. 569. NOTIFICATION.

TITLE II--RESPONSE

SEC. 201. ADMINISTRATIVE DETENTION.

SEC. 202. DESTRUCTION OF ADULTERATED, MISBRANDED, OR COUNTERFEIT DRUGS OFFERED FOR IMPORT.

SEC. 203. CRIMINAL PENALTIES.

SEC. 204. CIVIL PENALTIES.

SEC. 205. SEIZURE.

SEC. 206. ASSET FORFEITURE.

TITLE III--IMPORTATION AND EXPORTATION

SEC. 301. DOCUMENTATION FOR ADMISSIBILITY OF IMPORTS.

SEC. 302. REGISTRATION FOR COMMERCIAL IMPORTERS; FEE.

`PART 7--IMPORTERS OF DRUGS

`SEC. 744. IMPORTERS OF DRUGS.

SEC. 303. REGISTRATION FOR CUSTOMS BROKERS.

SEC. 304. EXPORTATION CERTIFICATE PROGRAM.

SEC. 305. EXTRATERRITORIAL JURISDICTION.

`SEC. 311. EXTRATERRITORIAL JURISDICTION.

SEC. 306. DEDICATED FOREIGN INSPECTORATE.

TITLE IV--MISCELLANEOUS

SEC. 401. UNIQUE IDENTIFICATION NUMBER FOR ESTABLISHMENTS, IMPORTERS, AND CUSTOMS BROKERS.

`SEC. 1013. UNIQUE IDENTIFIER.

SEC. 402. COUNTRY OF ORIGIN LABELING.

SEC. 403. FALSE OR MISLEADING REPORTING TO FDA.

SEC. 404. SUBPOENA AUTHORITY.

`SEC. 312. EXERCISE OF SUBPOENA AUTHORITY.

SEC. 405. WHISTLEBLOWER PROTECTIONS.

`SEC. 1014. PROTECTIONS FOR EMPLOYEES WHO REFUSE TO VIOLATE, OR WHO DISCLOSE VIOLATIONS OF, THIS ACT.

SEC. 406. RULE OF CONSTRUCTION.

END