show episodes
 
Welcome to Compounding Pharmacies by PharmaSalon. We feature discussions on regulatory, policy, compliance and business issues specifically for the compounding pharmacy industry. The podcast covers topics related to 503As, 503Bs, Hospital Pharmacies and Veterinary. I hope you will tune into all of our discussions as you never know when and where an idea will germinate that will take your business to the next level
 
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show series
 
This is another episode on our Tech2Leader series. I know its currently a hot topic, raising the profile and opportunities of technicians. Which is why I love bringing these stories of people who started out as a technician and were able to blaze a path to leadership roles How to Integrate Compliance Procedures into Business Activities Part1: https…
 
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 con…
 
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. Support the show (https://www.buymeacoffee.com/pharmasalon)By Peter Koshland, Jim Hrncir
 
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 pr…
 
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 …
 
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 mar…
 
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 ang…
 
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 su…
 
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…
 
In my role I am always hearing about the importance of the industry to achieve the highest standards of quality. This obviously effects interactions with state boards and the FDA as well as patients and the publics perception of the industry. Through out the years we have had many sessions on achieving quality through process and procedure. Today w…
 
We all know that the adoption of USP 800 has been banging around for what seems like ages. I have been talking to people like Bryan about it for over a year. Bryan and I specifically have been discussing the budgeting issues and misconceptions there are regarding upgrading to USP 800, so I was particularly excited to do this podcast. I think it’s a…
 
As many of us have, I've been discussing USP 800. For what feels like years now, which is saying something because I've not been in the compounding space for that long. There's so many issues involved. The one I hear most often probably because it's the most expensive is how does a pharmacist who doesn't know anything about construction, carpentry,…
 
We are having this conversation on blockchain technology. Its something I have been interested in and following for several years now. I was talking with Syed Saleem about his October presentation on qualifying equipment and products within the supply chain, and it got me thinking about big pharma, and how they are trying to address counterfeit dru…
 
A few weeks ago, I was speaking with a friend who works in private equity, she told me about a firm that was moving into the 503A compounding pharmacy space, I was intrigued by what it was they were looking to do and how they were going to do it. Given the massive amount of expenses and regulation that are facing the community. I was wondering how …
 
This episode is with Carlos Aquino fromPharmaDiversion. I've been privy to many of Carlos his stories over the years. They're always entertaining and really shine a light on the missteps that happen in both 503A and 503B compounding pharmacies. I asked Carlos if he would like to talk about some of those issues that he sees while doing DEA mock insp…
 
I am very I'm very excited about this episode. One of the topics that I have been exploring for our upcoming salon is moving technicians up through the ranks into leadership roles. I love big picture ideas and things that have to do with culture and cultural changes so I am naturally excited about this this issue. At our October event we're going t…
 
My guest today is from Infuserve America, a 503A that has a division that focuses on investigational drugs, otherwise known as clinical trials. I was first introduced to this idea by some associates at a pharmaceutical company, they told me how they struggled to find 503A's to work with due to a variety of reasons. Some are because of misconception…
 
Welcome to part two of our talk on how to integrate compliance procedures into business activities with Karla Palmer, Director at Hyman Phelps and McNamara. Kimberly Kiefer, Director of regulatory affairs at Empower Pharmacy, and Travis Leeah, VP of clinical services and pharmacists in charge at QuVa Pharma. In our last episode, we discussed the ch…
 
Welcome to another episode in our series on partnering for growth. In this installment I continue my conversation with Greg McKetrick from Stanley Pharmacy about looking outside your organization for growth opportunities. After a discussion about expanding your reach and your community Greg and I got to talking about a company that has become parti…
 
This episode for 503Bs has to do with compliance. I know this is a big issue that has a lot of complexity and is a constant source of training and conversation. Since compliance is so integral to the operation of a compounding pharmacy I was having lots of discussions on staff training, procedures, sops etc. and it got me thinking, what is the best…
 
I wanted to explore how compounding pharmacies can grow their business. I know, particularly with 503A’s that compounding pharmacies are looking for new ways to increase revenue and I became intrigued with the idea of finding new markets that a pharmacy may not have initially intended when they opened for business. One of the things that I want to …
 
Learning Objectives Discuss the importance of particulate in relation to microorganisms Explain why 0.5 micron and larger sized particles are of great importance Discuss 3 ways that we can minimize the number of particles in our cleanroom In todays 483 we're going to be looking at non-viable particle counts otherwise and more accurately known as to…
 
Learning Objectives Discuss the importance of low levels of endotoxins in parenteral preparations Discuss the limits for endotoxins for various routes of administration Discuss ways to control the levels of endotoxins in final preparations In this weeks' 483 we're going to be talking about Bacterial Endotoxins and the testing related to endotoxins.…
 
Learning Objectives Discuss the use of USP graded ingredients in pharmaceutical preparations and the importance Explain what prompted the FD&C act of 1938 to be enacted In this weeks 483 Friday we're going to be talking about the use of ungraded ingredients in pharmaceutical preparations. First, I'd like to show you a 483 where this was done, then …
 
Learning Objectives Explain the purpose of viable air sampling Discuss how conclusions can be made from the results of viable air sampling Happy Friday! This weeks 483 we're going to focus on viable air sampling, which is one part of an environmental sampling plan. The information gained from viable air sampling can be very telling of the cleanline…
 
The learning objectives for this week’s 483: Discuss the engineering control requirements for handling and compounding with hazardous drugs List two agents that can be used to deactivate hazardous drugs Discuss the 4 steps required to properly remove hazardous drugs from surfaces and equipment In this week's 483 we're going to look at the importanc…
 
The learning objectives for this week's 483: Explain the typical out of specification range of potency for many compounded formulations Discuss a type of testing that is both economical and scientifically sound Discuss the 5 elements of an SOP on potency testing should include This week we'll be looking at one observation the FDA made at a facility…
 
In this week's 483 we're going to talk about investigating microbial contaminations inside the cleanroom to find out possible sources and remediate the issue. We're also going to talk about writing up that investigation and the resulting corrective action/preventive action or CAPA as a result.By Seth DePasquale
 
Having issues controlling temperature in your cleanroom? Here's what NOT to do and what you should do... Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site! SUBSCRIBE: You Tube Stitcher Anchor FM iHeart Spotify Radio Public Pocket Casts over cast Cast box Podcast App Breaker Google Podcasts iTunes Podbean…
 
This week we welcome Brenda Jensen and Jim Hack of Compounding Consultants to the podcast. They both began their pharmacy careers as technicians over 30 years at an Air Force Base and now consult pharmacies, large and small, in compounding compliance for seeking accreditation. We'll be having a discussion on compliance with USP , specifically about…
 
This week we welcome Tom Kupiec to the podcast. Tom is the owner of ARL (Analytical Research Laboratories) Oklahoma City, Oklahoma. To learn more about the contamination control webinar go to: https://pharmacyinspection.com/product/a-compounders-guide-to-hazardous-drug-compounding-workflow/ Join us for the USP Hazardous Drug Workflow & Containment …
 
This week we welcome Kim Kieffer to the podcast. Kim is the Director of Corporate Relations at Empower Pharmacy in Houston Texas. She’s been a compounding consultant at Spectrum, Letco and Freedom Pharmaceuticals. Most recently she was the Academy Manager at Fagron educating pharmacists and technicians. She has a wealth of knowledge when it comes t…
 
This week we welcome Melissa Stefko, from Wells Pharmacy Network to the podcast. Melissa Stefko, Senior Director of Quality for 503B Wells Pharmacy Network, will be discussing contamination control as it relates to pharmaceutical compounding. Ms Stefko is an experienced Pharmaceutical and Biotechnology professional with a background in Quality Assu…
 
This week Greg Stowell and Jon Pritchett from PCAB (ACHC) speak with us about a new course they've released that teaches you all about becoming compliant with the Designated Person requirement within USP 800. Found out more about the ACHC Designated Person Course HERE! (https://accreditationuniversity.com/hdhdp) Watch the Lean 6 Sigma Process impro…
 
This week Bryan and I talk about Process Improvement! We give specific examples of how to start out improving a few processes within your own pharmacy. Announcement: Upcoming FREE Webinar! SIGN UP HERE (CLICK HERE) Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site! SUBSCRIBE: [caption id="attachment_16757" alig…
 
This week Bryan and I talk about Compounding Design Theory! This podcast stemmed from a conversation Bryan and I had about a hood that he helped design for Encore Scientific (pictured on left); a hood with a clear view from any angle. Which is extremely helpful from the the perspective of the PIC; who at any moment could be doing any number of thin…
 
Thanks SO so much for everyone that did tune in; I promise next live event I will DEFINITELY RAISE THE BAR!!! I've fixed most of the audio issues and I believe we'll revisit this conversation again the very near future! LAST WEEK USP announced the proposed revisions of 797. Join Jon Pritchett, Bryan Prince and I for a SPECIAL EDITION of the Pharmac…
 
This week we broadcast our interview that we recorded at CCH in June. Bryan was able to sit down with Jeanine Sinanan-Sing, co-founder and CEO of Vitae Industries, maker of the AutoCompounder 3D printer . They talk about their platform and the exciting possibilities available with its use. Thanks again to our sponsor for CCH: Encore Scientific. If …
 
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