Must Read: Great summaries over at FDA LAW Blog on the recent FDA draft guidance-including MOU--

FDA Officially Releases Four Compounding Draft Guidance Documents and Its Draft Memorandum of Understanding; Part Two: FDA Provides Details on the Draft Standard MOU

By Karla L. Palmer –

Following our blogpost describing the four human drug compounding draft guidance documents and draft Memorandum of Understanding (MOU) that FDA released last Friday, FDA formally published the documents in the Federal Register on February 19th.   Interested persons should note the docket numbers in the notices so they can post comments (due 90 days from today for the four draft guidances and 120 days after today’s publication for the draft standard MOU).  FDA also finally withdrew the draft MOU that it issued in January 1999 (to our knowledge no state had signed it).  That 1999 draft, which received over 6,000 public comments, defined “inordinate amounts” as when the number of compounded drugs dispensed or distributed interstate annually is equal to or greater than 20 percent of all drugs dispensed by the facility, and contained other controversial provisions.  Recall that under FDCA Section 503A, states have a choice of either signing an MOU with FDA, or human drug compounders within that state acting pursuant to Section 503A must limit out of state shipments to 5 percent of all prescription orders dispensed or distributed by the pharmacy or physician.  more