Transitioning From a 503A To a 503B - Part 1

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By Vivian Juter Frankel. Discovered by Player FM and our community — copyright is owned by the publisher, not Player FM, and audio is streamed directly from their servers. Hit the Subscribe button to track updates in Player FM, or paste the feed URL into other podcast apps.

This is a another 3-part episode. Throughout the years there has been a lot of talk about moving from a 503A to a 503B compounding pharmacy. I know there are a lot of pros and cons, as there are to changing any business model. In this series we are going to hear Kim Kieffer talk about Empowers move to a 503B and what are the considerations when contemplating such a move. For your convenience I have broken this hour long talk into 3 episodes. The first one talks about the key differences between a 503A and a 503B, why become a 503B outsourcing facility, how to do it, the principle of a cGMP environment and Quality systems that need to be implemented.

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