I just came across this today, here's an excerpt from the article:
Unprecedented Expansion of FDA Oversight
The intent of the original MOU was to prevent compounding pharmacies from becoming manufacturers and limited office use prescriptions. The FDA has since taken that intent and expanded it into unprecedented areas of oversight and regulation to include interstate commerce.
The current draft MOU would restrict compounding pharmacies to no more than 5% of interstate sales per month unless their respective state agrees to enter into a MOU agreement with the FDA. If the state agrees to bear the burden for any adverse events or quality issues, then those pharmacies may increase their interstate sales to 30%.
To me, it seems unconstitutional to restrict our ability to receive medications by placing an arbitrary limit on interstate sales for compounding pharmacies. The comment period has ended, however in the article there is a take action link to email your senators to support an amendment that would end the interstate cap. In addition, I'll be sending a hand typed letter to my senators. I know many of us count on compounded medications and to me this is very important. I know there are some pharmacists on this board, I would be curious to hear their thoughts.
http://campaign.r20.constantcontact...a8786&ch=f8804d20-370c-11e3-b404-d4ae529a8786
Unprecedented Expansion of FDA Oversight
The intent of the original MOU was to prevent compounding pharmacies from becoming manufacturers and limited office use prescriptions. The FDA has since taken that intent and expanded it into unprecedented areas of oversight and regulation to include interstate commerce.
The current draft MOU would restrict compounding pharmacies to no more than 5% of interstate sales per month unless their respective state agrees to enter into a MOU agreement with the FDA. If the state agrees to bear the burden for any adverse events or quality issues, then those pharmacies may increase their interstate sales to 30%.
To me, it seems unconstitutional to restrict our ability to receive medications by placing an arbitrary limit on interstate sales for compounding pharmacies. The comment period has ended, however in the article there is a take action link to email your senators to support an amendment that would end the interstate cap. In addition, I'll be sending a hand typed letter to my senators. I know many of us count on compounded medications and to me this is very important. I know there are some pharmacists on this board, I would be curious to hear their thoughts.
http://campaign.r20.constantcontact...a8786&ch=f8804d20-370c-11e3-b404-d4ae529a8786
