Sunday, May 12, 2013

Ten Reasons Congress should Quickly Pass the Proposed Federal Legislation to Regulate Compounding And Get Busy Inspecting!!!

Sue Tuck Richmond
May 11, 2013

Previously I wrote  a post listing ten reason why Congress should not pass the proposed federal legislation.  now I am going to play devil's advocate and list ten reasons why Congress should quickly pass this legislation.

1.  The compounding world, both human and animal, is out of control. Congress has to begin somewhere in trying to reform and regulate the compounding  world.  This bill is a good start.

2.  States clearly have not done a good job of regulating compounding and it is not clear they can or will  do the job.

3.  In doing the recent inspections, the FDA showed they are clearly capable of quickly inspecting  and regulating the compounding world if given the proper set of tools.

4. The best way to get control of the compounding world and to work toward ensuring another NECC outbreak does not occur is for the federal government to be responsible for regulating "compounding manufacturers."

5.  Major organizations, including IACP and NABP, are supporting this legislation.

6.  Traditional compounders will still be regulated by the states.

7.   The FDA does not know the extent of the problems in the compounding  world nor do the states.  The only way for transparency is to give the FDA the power to review the records and obtain the information they need.

8.  Requiring "manufacturing compounds" to pay an inspection fee is fair in light of the amount of money compounders are making.

9.  The compounding world is highly political with large amounts of money being paid to state  representatives, congress etc.  This type of environment breeds corruption, fraud, kickbacks, etc. When this happens the best and really the only way to halt it is to allow the federal government to regulate it.

10.  As  I have stated before to make room for the good compounders you have to get rid of the bad compounders.  Only through recent federal enforcement have bad compounders inspected, fined,  and forced to recall bad products.  This potentially prevented another NECC outbreak.  Giving the FDA jurisdiction increases the chance of preventing future outbreaks or at least containing them before deaths occur.

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