The House just held its first legislation-focused compounding hearing, and it was also the first where PhRMA was asked for its input. The trade group opposes a Senate bill measure that would add a third category of so-called “compounding manufacturers” – but GPhA’s non-committal position may be a better indicator of the potential.
One of the main questions in creating compounding legislation is whether to create a separate category of non-traditional compounders: those that should be regulated by FDA and be required to comply with Good Manufacturing Practices, but not have all the responsibilities of a manufacturer.
That’s the approach taken in the compounding bill
that passed the Senate Health Committee and is awaiting action on the
floor; the House instead prefers to “clarify” FDA’s existing
authorities, which currently would include using a variety of factors to
draw a line between traditional compounders and larger-scale
compounding operations. Much of the a July 16 Energy & Commerce Health Subcommittee Hearing focused on what criteria should be used to draw that line; Rep. Morgan Griffith (R-VA)’s discussion draft
currently has a placeholder for volume limitations. (“Compounder Definition In House Bill May Use Blended Metrics”, The Pink Sheet Daily, July 17, 2013.) continue to read here
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