Pharmaceutical Compounding
A pharmaceutical compounding bill to more clearly define the roles of the Food and Drug Administration and state boards of pharmacy in overseeing pharmaceutical compounding facilities, which custom mix drugs, could become law by year's end.
A bipartisan Senate bill passed out of committee in May, and supporters hoped for, but did not get, a vote before the August recess. Senate Health, Education, Labor, and Pensions Committee Chairman Tom Harkin, D-Iowa, and ranking member Lamar Alexander, R-Tenn., introduced an updated version of the legislation in July.
The House version of the legislation hasn't gotten out of committee yet, and a discussion draft introduced by Rep. Morgan Griffith, R-Va., differs from the Senate version in how it categorizes compounding facilities for regulation. The House has passed a separate bill to more closely track drugs through the nation's supply chain, something that would be done in the Senate Health and Education Committee's compounding bill.
Hope remains that legislation could be enacted this year, in part because the momentum to pass new regulations has been steady since last fall's deadly outbreak of fungal meningitis from tainted steroid injections produced by a compounding center in Massachusetts. Hundreds became sick from the injections and more than 60 died, according to the Centers for Disease Control and Prevention.
On Monday, Alexander pointed to another reason Congress should pass a compounding bill: FDAissued a voluntary recall this weekend of compounded drugs from a Texas-based company citing concerns that they may have been responsible for an outbreak of bacterial bloodstream infections.
A bipartisan Senate bill passed out of committee in May, and supporters hoped for, but did not get, a vote before the August recess. Senate Health, Education, Labor, and Pensions Committee Chairman Tom Harkin, D-Iowa, and ranking member Lamar Alexander, R-Tenn., introduced an updated version of the legislation in July.
The House version of the legislation hasn't gotten out of committee yet, and a discussion draft introduced by Rep. Morgan Griffith, R-Va., differs from the Senate version in how it categorizes compounding facilities for regulation. The House has passed a separate bill to more closely track drugs through the nation's supply chain, something that would be done in the Senate Health and Education Committee's compounding bill.
Hope remains that legislation could be enacted this year, in part because the momentum to pass new regulations has been steady since last fall's deadly outbreak of fungal meningitis from tainted steroid injections produced by a compounding center in Massachusetts. Hundreds became sick from the injections and more than 60 died, according to the Centers for Disease Control and Prevention.
On Monday, Alexander pointed to another reason Congress should pass a compounding bill: FDAissued a voluntary recall this weekend of compounded drugs from a Texas-based company citing concerns that they may have been responsible for an outbreak of bacterial bloodstream infections.
quoted from source found here