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H.R.3204: Drug Quality and Security Act

About this Bill

This bill was introduced in the 113th Congress
This bill is primarily about health
You can read the bill
Sponsor Fred Upton, R-Mich.
Total Cosponsors 10 (6 Democrats, 4 Republicans)
Introduced Sept. 27, 2013
Latest Major Action Nov. 27, 2013
See it on GovTrack
See it on C-SPAN

Bill Progress

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

Bill Summary

(This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)

Drug Quality and Security Act - Title I: Drug Compounding - Compounding Quality Act - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounding drugs. Exempts compounded drugs from new drug requirements, labeling requirements, and track and trace requirements if the drug is compounded by or under the direct supervision of a licensed pharmacist in a registered outsourcing facility and meets applicable requirements.

Establishes annual registration requirement for any outsourcing facility. Requires a facility to report biannually to the Secretary of Health and Human Services (HHS) on what drugs are compounded in the facility and to submit adverse event reports. Subjects such facilities to a risk-based inspection schedule.

Requires the Secretary to: (1) publish a l...

(Source: Congressional Research Service)

Bill Actions

Date Description
Nov. 27, 2013 Became Public Law No: 113-54.
Nov. 27, 2013 Signed by President.
Nov. 21, 2013 Presented to President.
Nov. 18, 2013 Message on Senate action sent to the House.
Nov. 18, 2013 Passed Senate without amendment by Voice Vote.
Nov. 18, 2013 Motion by Senator Reid to commit to Senate Committee on Health, Education, Labor, and Pensions with instructions to report back forthwith with amendment SA 2035 withdrawn in Senate. (consideration: CR S8071)
Nov. 18, 2013 Cloture motion withdrawn by unanimous consent in Senate. (consideration: CR S8071)
Nov. 18, 2013 Considered by Senate. (consideration: CR S8071-8076)
Nov. 14, 2013 Cloture motion on the measure presented in Senate. (consideration: CR S8027; text: CR S8027)
Nov. 14, 2013 Motion by Senator Reid to commit to Senate Committee on Health, Education, Labor, and Pensions with instructions to report back forthwith with amendment SA 2035 made in Senate. (consideration: CR S8026; text: CR S8026)
Nov. 14, 2013 Measure laid before Senate by motion. (consideration: CR S8026, S8027)
Nov. 14, 2013 Motion to proceed to consideration of measure agreed to in Senate by Voice Vote.
Nov. 13, 2013 Motion to proceed to measure considered in Senate. (consideration: CR S7973-7996)
Nov. 12, 2013

Cloture on the motion to proceed to the measure invoked in Senate by Yea-Nay Vote. 97 - 1. Record Vote Number: 234. (consideration: CR S7949-7950; text: CR S7949)

Nov. 12, 2013 Motion to proceed to consideration of measure made in Senate. (consideration: CR S7949-7950)
Nov. 7, 2013 Cloture motion on the motion to proceed to the measure presented in Senate. (consideration: CR S7923-7924; text: CR S7923-7924)
Nov. 7, 2013 Motion to proceed to consideration of measure made in Senate. (consideration: CR S7891-7894, S7909-7920, S7923-7924)
Nov. 6, 2013 Motion to proceed to consideration of measure withdrawn in Senate. (consideration: CR S7864)
Nov. 6, 2013 Motion to proceed to consideration of measure made in Senate. (consideration: CR S7841-7845, S7846-7864)
Nov. 5, 2013 Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 236.
Nov. 4, 2013 Read the first time. Placed on Senate Legislative Calendar under Read the First Time.
Sept. 30, 2013 Received in the Senate.
Sept. 28, 2013 On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H5946-5960)
Sept. 28, 2013 DEBATE - The House proceeded with forty minutes of debate on H.R. 3204.
Sept. 28, 2013 Considered under suspension of the rules. (consideration: CR H5946-4965)
Sept. 28, 2013 Mr. Upton moved to suspend the rules and pass the bill.
Sept. 27, 2013 Referred to the House Committee on Energy and Commerce.