To direct the Secretary of Health and Human Services to conduct a pilot program under which the Secretary increases the conduct of unannounced inspections of foreign human drug establishments and evaluates the differences between inspections of domestic and foreign human drug establishments, including the impact of announcing inspections to persons who own or operate foreign human drug establishments in advance of an inspection.

3/8/2023, 7:58 PM

This bill requires the Food and Drug Administration to conduct a pilot program to increase the number of unannounced inspections of foreign drug manufacturing facilities and evaluate the differences between inspections of domestic and foreign facilities.

Bill 117 HR 6980, also known as the Foreign Drug Inspection Pilot Program Act, aims to improve the oversight of foreign human drug establishments by directing the Secretary of Health and Human Services to conduct a pilot program. This program would involve increasing the frequency of unannounced inspections of foreign human drug establishments and evaluating the differences between inspections of domestic and foreign establishments.

The bill specifically focuses on the impact of announcing inspections to persons who own or operate foreign human drug establishments in advance. By conducting unannounced inspections, the goal is to ensure that these establishments are meeting the same standards and regulations as domestic establishments.

The pilot program will allow for a comparison of the effectiveness of announced versus unannounced inspections in ensuring compliance with regulations. This information will be crucial in determining the best practices for oversight of foreign human drug establishments. Overall, the Foreign Drug Inspection Pilot Program Act seeks to strengthen the oversight of foreign human drug establishments to ensure the safety and efficacy of drugs imported into the United States.
Congress
117

Number
HR - 6980

Introduced on
2022-03-08

# Amendments
0

Sponsors
+5

Cosponsors
+5

Variations and Revisions

3/8/2022

Status of Legislation

Bill Introduced
Introduced to House
House to Vote
Introduced to Senate
Senate to Vote

Purpose and Summary

This bill requires the Food and Drug Administration to conduct a pilot program to increase the number of unannounced inspections of foreign drug manufacturing facilities and evaluate the differences between inspections of domestic and foreign facilities.

Bill 117 HR 6980, also known as the Foreign Drug Inspection Pilot Program Act, aims to improve the oversight of foreign human drug establishments by directing the Secretary of Health and Human Services to conduct a pilot program. This program would involve increasing the frequency of unannounced inspections of foreign human drug establishments and evaluating the differences between inspections of domestic and foreign establishments.

The bill specifically focuses on the impact of announcing inspections to persons who own or operate foreign human drug establishments in advance. By conducting unannounced inspections, the goal is to ensure that these establishments are meeting the same standards and regulations as domestic establishments.

The pilot program will allow for a comparison of the effectiveness of announced versus unannounced inspections in ensuring compliance with regulations. This information will be crucial in determining the best practices for oversight of foreign human drug establishments. Overall, the Foreign Drug Inspection Pilot Program Act seeks to strengthen the oversight of foreign human drug establishments to ensure the safety and efficacy of drugs imported into the United States.
Alternative Names
Official Title as IntroducedTo direct the Secretary of Health and Human Services to conduct a pilot program under which the Secretary increases the conduct of unannounced inspections of foreign human drug establishments and evaluates the differences between inspections of domestic and foreign human drug establishments, including the impact of announcing inspections to persons who own or operate foreign human drug establishments in advance of an inspection.

Policy Areas
Health

Comments

Recent Activity

Latest Summary9/20/2022

This bill requires the Food and Drug Administration to conduct a pilot program to increase the number of unannounced inspections of foreign drug manufacturing facilities and evaluate the differences between inspections of domestic and foreign fac...


Latest Action3/9/2022
Referred to the Subcommittee on Health.