Please Read This: The Reason for Regulating Drugs--U.S. Supreme Court words on compounded drugs

Court Justice Stephen Breyer has explained why it is important not to deviate from the strict safety requirements for drugs under the federal Food Drug and Cosmetics Act:

The objective of this elaborate and time consuming regulatory regime is to identify those health risks—both large and small—that a doctor or pharmacist might not otherwise notice.

That objective, as the Court concedes, is to confine the sale of untested, compounded drugs to where they are medically necessary.

quoted from here