Michael A. Walsh from Strasburger and Price makes a very important point about Congress directing the FDA to issue regulations and not mere guidance--

There is little doubt that the proposed Compounding Quality Act will provide the FDA with significant oversight over sterile compounding facilities, and will provide the FDA, state regulators and consumers with increased transparency on the scope of "unapproved" compounded sterile preparations on the market. Congress has directed the FDA to issue regulations (not Guidance) governing pharmacy compounding but no deadline was set for publication of a proposed rule. How the FDA will reign in the burgeoning business of non-sterile compounding will need to await the rulemaking process.

quoted from here

United States: Something Old, Something New, Something Borrowed And Something Missing

Last Updated: October 15 2013

Article by Michael A. Walsh

Strasburger & Price, L.L.P.