Breaking News: FDA Testifies Before Senate HELP Committee, Questioned On Recent Compounding Quality Act Enforcement

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Today Senator Lamar Alexander (R-TN), member of the Senate HELP Committee asked FDA Commissioner Margaret Hamburg what FDA's policy was with regard to asserting jurisdiction over 503A traditional compounding pharmacies. He specifically questioned FDA's enforcement of the new Compounding Quality Act beyond the intent of the legislation. We have analyzed the Committee's questions and FDA's responses, and are preparing a summary for members of the Coalition for Responsible Compounding. The CRC will also hold a member meeting on Tuesday, March 18 at 10P/11M/12C/1E.

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This story is still developing, please email for additional information on the summary and the call:

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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