Pharmaceutical Quality, Security, and Accountability Act

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.

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Timeline

1. 15 May 2013

   Introduced

   Introduced in Senate

   Source: IntroReferral

2. 15 May 2013

   Introduced

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

   Source: IntroReferral

3. 22 May 2013

   Reported

   Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.

   Source: Committee

4. 19 June 2013

   Calendars

   Placed on Senate Legislative Calendar under General Orders. Calendar No. 89.

   Source: Calendars

5. 19 June 2013

   Reported

   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.

   Source: Committee

6. 19 June 2013

   Reported

   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.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Reported to Senate · 19 June 2013 · Download file
• Introduced in Senate · 15 May 2013 · Download file

Documents

6 official files

• Reported to Senate (text)

  Reported to Senate · EN · 19 June 2013

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• Reported to Senate (PDF)

  Reported to Senate · EN · 19 June 2013

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• Reported to Senate with amendment(s)

  summary · EN · 19 June 2013

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  Vertaal document

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• Introduced in Senate (text)

  Introduced in Senate · EN · 15 May 2013

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  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 15 May 2013

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  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

• Introduced in Senate

  summary · EN · 15 May 2013

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Sen. Harkin, Tom [D-IA] · D · Sponsor
• Sen. Alexander, Lamar [R-TN] · R · Sponsor
• Sen. Roberts, Pat [R-KS] · R · Sponsor
• Sen. Franken, Al [D-MN] · D · Sponsor
• Sen. Mikulski, Barbara A. [D-MD] · D · Sponsor
• Sen. Warren, Elizabeth [D-MA] · D · Cosponsor
• · sshr00 · Standing

Related records

• related to → Drug Quality and Security Act
• related to → Drug Supply Chain Security Act
• amends ← SAMDT 1826
• amends ← SAMDT 1827
• amends ← SAMDT 1828
• amends ← SAMDT 1829