Recorded September 24, 2020 | On-Demand Webinar
The Memorandum of Understanding establishes an agreement between states that sign on to the MOU and the FDA regarding the interstate distribution of compounded drugs by compounding pharmacies, known as 503A compounders. The MOU, released earlier this year, addresses the limit on prescription orders that can be distributed out-of-state by states that do not sign onto the MOU. The law limits distribution to 5% of the total prescription orders dispensed or distributed. The MOU also defines the statutory term of “inordinate amounts” as it relates to the proportion of compounded drugs that may be distributed interstate for compounders in states who have signed onto the MOU. Another area addressed is reporting requirements and investigations of complaints conducted by states. This panel will address questions and concerns related to the above, including FDA’s implementation of the 5% limit, the pharmacy perspective on this limit, and the importance of the limit and the MOU in general from the health care policy perspective.