Thank you for tuning into part 3 our 3-part series on moving from a 503A to a 503B. In this episode Kim Kieffer talks about the process, investigations, quality, documentation staffing, regulations and the investment. 

Thank you for tuning into part 2 our 3-part series on moving from a 503A to a 503B. In this episode Kim Kieffer reviews qualifying vendors and equipment, environmental monitoring, validation and formulation and release cycles. 

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. 

In this episode, we're continuing our conversation about BHRT. We have with us two pharmacy owners who have been talking to the public about BHRT the FDA and how what is going on will affect patients as well as 503A pharmacist.

This episode we are talking about an area that we don’t hear much about. It has to do with some of the ambiguity on quality and process in the proposed FDA guidance for the industry on the current good manufacturing practice the guide for human compounding outsourcing facilities under Section 503B. Specifically we are discussing the Vial Capping process. I was introduced to this subject by Amy Summers who had just written an article with Neal Higgins from West Pharma about it.  I wanted to do this episode because I have been told that people don’t realize how hugely connected sterility assurance is to container closure integrity and we focus so much on sterility testing but never really talk about, and clearly we should, container closure integrity.  I also want to mention that even though throughout this we are referring to cGMP and Section 503B there is also some important information and thoughts for r 503As so I hope they listen to this as well.

Part 2: In our last episode with Darshan and compliance for your sales team, we covered fair market value the False Claims Act and the anti kickback law. During this installment Darshan will review cases of pharmacies that are under investigation why the fines and penalties associated with their transgressions and how marketers can get in sued for their involvement. If you would like to see the PowerPoint slides that accompany this information, go to the farmers salon YouTube channel. You can find it by typing in our name farmer salon. If you have any questions for Dr. Shawn. He can be contacted at 302-252-6959 and on Twitter at Darshan talks. If you liked this podcast, don't forget to subscribe or leave a comment. You can do so on our Twitter, Facebook or LinkedIn page or you can leave us a voicemail message on our website.

You can watch this presentation with the PPT on our youtube channel. Click here

We talk a lot about compliance usually its compliance within the pharmacy. Today I have Darshan Kulkarni from the Kulkarni law firm talking about compliance with your sales team. Since there's so much information to impart this topic is broken into two sections during the first one Darshan will discuss some of the key regulations regarding fair market value, the False Claims Act and the anti kickback law. Part Two, will cover examples of pharmacies that are under investigation, why the fines and penalties associated with their transgressions and how marketers can get sued for their involvement. If you'd like to see the PowerPoint slides that accompany this information, you can watch the video on our YouTube channel. You can find it by typing in our name PharmaSalon If you have any questions for Darshan he can be contacted at 302-252-6959 or on Twitter @Darshan talks. If you like this podcast, don't forget to subscribe or leave a comment. You can do so on Twitter, Facebook or  our LinkedIn page. You can also leave us a voicemail on our website.


You can watch this presentation with the PPT on our youtube channel. Click here

My guest today is Robert MacArthur Pharmacy Director at the Rockefeller University Hospital. Robert has been involved in the drug industry for about 33 years and has a wealth of experience from working in pharma as well as pharmacies and academia. I was excited to speak with him about this topic because I like to explore subjects from different angles. We spoke with Alex Pytlarz from Infuserve America,  a 503A, about their experience in investigational drugs and I really wanted to get their perspective from someone from a research institution and what it is they look for when looking to work with a 503As.

This week we are talking to Rachel Simmons, the General Manager of Stanley Specialty Pharmacy. Rachel is part of our series on Tech2Leaders. This is a focus on technicians expanding their roles in compounding pharmacies. I would love to hear your thoughts and comments. Leave us a voice mail on our site pharmasalon.com/podcsts and don’t forget to subscribe to the podcast on your favorite podcast player

We're here today to talk about BHRT and the potential FDA restrictions on the delivery of these therapies that will result in decreased patient access.  Rachael Pontikes and Emily Hussey are going to give us an update on what's going on. We're going to be talking about this a little bit more at the event in October, the grand salon, but I thought it'd be really interesting before then to kind of just touch base with Rachael and Emily, and see what's going on now.

I would love to hear any comments or thoughts you have. Go to our website www.pharmasalon.com/podcasts and leave us a voicemail.