Breaking News: Senate Releases Draft Compounding Legislation

This week Republican and Democrat staffers from the Senate Committee on Health Education, Labor, and Pensions (HELP) met to discuss the provisions included in an early version of bipartisan legislation to address regulatory gaps in oversight of compounding outsourcers

The advocacy community has been actively engaged with HELP Committee staff as they have developed legislative language and has sought to distinguish patient-care driven hospital and health-system compounding from commercial compounding provided by compounding outsourcers.

The draft legislation establishes a boundary between traditional pharmacy compounding and defines a new entity, “compounding manufacturer,” which compounds preparations without or in advance of a prescription and engages in interstate commerce. It also preserves the states’ primary role in regulating traditional pharmacies.

Most importantly for hospital pharmacies, interstate shipment within a hospital system will not cause a hospital pharmacy to be considered a compounding manufacturer and subject to registration with the Food and Drug Administration.

Advocates are initially pleased with the draft legislation developed by the bipartisan working group of the Committee.  

Advocacy groups will thoroughly review the discussion draft and submit comments to the Committee by its May 3 deadline. Final committee action is anticipated by Memorial Day. Look for more updates on the legislation in the coming days.,Chair

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