Monday, December 15, 2014

Sixth Question of the Day December 15, 2014: FDA; Manufacturing v. Permissible Compounding

 Does the FDA need to be more aggressive against those compounding pharmacies pretending to be traditional, not registered as outsourcers, but really manufacturing by the amount of preparations (sterile and non sterile) , number of states licensed in, amount of repeat/same preparation being massed produced for multiple consumers, type of advertising etc.? Then when compounders complain to Congress because they are being nailed for manufacturing what will Congress say when the business model looks very similar to that of NECC's business model?

1 comment:

Anonymous said...

I think there needs to be a separate standard. the small town community compounders are suffering for the actions of these "manufacturers" (call them what they are). Its kinda like Walmart and Target have all but killed the small Mom and Pop stores. if you are licensed in more than the state in which you retail counter is, then you are a manufacturer. I personally think there is a Compounding Pharmacy and a compounding manufacturer. and i think they need to be regulated as such.