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S.959: Pharmaceutical Quality, Security, and Accountability Act

About this Bill

This bill was introduced in the 113th Congress
This bill is primarily about health
You can read the bill
Sponsor Tom Harkin, D-Iowa
Total Cosponsors 5 (3 Democrats, 2 Republicans)
Introduced May 15, 2013
Latest Major Action June 19, 2013
See it on GovTrack
See it on C-SPAN

Bill Progress

  • Bill introduced in the Senate   
  • Bill passed in the Senate   
  • Bill passed in the House   
  • Bill signed into law

Bill Summary

Pharmaceutical Quality, Security, and Accountability Act - Title I: Human Drug Compounding - Pharmaceutical Compounding Quality and Accountability Act - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the regulation of compounded drugs.

Subjects a compounded drug to all FFDCA requirements applicable to new drugs. Sets forth exceptions from new drug requirements, biological product requirements, labeling requirements, and good manufacturing practice requirements for a drug that: (1) is compounded by a traditional compounder, and (2) meets applicable requirements.

Defines “traditional compounder” as a facility operating pursuant to state law that meets certain criteria, including that a drug is compounded by a licensed pharmacist or licensed physician pursuant to a prescription order for an identified individual patient or compounded in limited qualities before a prescription order based on history of receiv...

(Source: Congressional Research Service)

Bill Actions

Date Description
June 19, 2013 Placed on Senate Legislative Calendar under General Orders. Calendar No. 89.
June 19, 2013 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.
May 22, 2013 Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
May 15, 2013 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.