PhLAG is a result of MEDISCA’s commitment to being an industry leader in the advancement of compounding, with the goal to ensure that every Pharmacy/Outsourcing Facility has a platform to learn, participate, and be heard.
The regulatory environment can be challenging to understand. State Boards of Pharmacy are currently struggling with how to implement revised chapters of the USP as well as the new <800> chapter. The revised chapter <795> brings a new requirement of stability testing without clarifying if the use of external studies will affect compliance. Furthermore, tensions arise between the states and the FDA’s newly introduced Memorandum of Understanding (MOU). Many states are concerned with the FDA’s definition of “distribution” and what the funding requirement is for inspection in the MOU.
Outsourcing Facilities, created by Congress, should be seeing greater cooperation from the FDA. Instead, tighter restrictions have been applied. During the past year, the release of guidance documents has limited the access to bulk drug substances; creating uncertainty within the industry.
PhLAG and MEDISCA want to help traditional compounding pharmacies, as well as outsourcing facilities, navigate these imperative issues. As an industry, we need to come together and inform ourselves of what is going on at state and federal levels. PhLAG will provide a platform accessible to all.
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