Another Good Point from Alere's Brief in the KV vs FDA Case ($KV)

"Because traditional compounding (within the limits set by Congress and FDA policy) is outside of the NDA requirements, and because the ODA only protects the manufacturer of an orphan drug from the issuance of a further NDA for the same drug and same indication, the ODA's protective scope does not circumscribe pharmacists' ability to engage in such compounding."

This is a great brief. I think Alere absolutely nails it.