S. 959 · 113th Congress
Pharmaceutical Quality, Security, and Accountability Act
- Stage
- Reported from committee
- Sponsor
- Tom Harkin
- Introduced
- 2013-05-15
- Latest action
- 2013-06-19 · Committee on Health, Education, Labor, and Pensions. Reported by Senator Harkin with an amendment in the nature of a substitute and an amendment to the title. Without written report.
Summary
Pharmaceutical Compounding Quality and Accountability Act - Sets forth provisions to revise the regulations regarding human compounding. Establishes requirements for animal drug compounding and biological product compounding. Requires the compounding manufacturers to: (1) register with the Secretary of Health and Human Services (HHS) annually, (2) report to the Secretary on the drugs it compounds, and (3) report serious adverse events associated with the use of compounded drugs. Requires the Secretary to assess establishment and reinspection fees.