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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 introduced in the Senate
- Bill passed in the Senate
- Bill passed in the House
- Bill signed into law
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)
|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.|