Moms Making Money

Dr. Jerrica Dodd, Found of Your Pharmacy Advocate and PharmaSis Magazine talks about the RX Influencer Salon, growth and being a pharmacist entrepreneurSupport the show

Join us as we discuss the medical cannabis industry and how the politics  apply to pharmacies looking to use it help patients as well as for compounders who want to try creating novel therapies with CBD. Support the show

 This week I am pleased to bring to you a podcast with regular Lou Diorio from LDT Healthcare.  We are talking about how technology is going to affect the future of pharmacy - particularly for compounders and hospitals.  I hope you enjoy this episode. Lou has a lot of great thoughts and information.Support the show

Many compounding pharmacies are watching the cannabis industry for Its potential as a great additional revenue. My guest today Craig Batogowski opened up a pharmacy and was compounding CBD for human and veterinary patients before he was shut down due to policy changes.  Listen to his experience and what compounders should be looking for to get into this niche in the future.Support the show

Part 3 of our talk with Abby Roth re SOP'sSupport the show

Support the show

Join us as we discuss common mistakes when building a clean that end up costing money as well as how to future proof your new build!Support the show (https://www.buymeacoffee.com/pharmasalon)

Today I am happy to be talking to Wendy Hagwood from Triangle compounding pharmacy.  We are continuing our conversation on veterinary compounding.   For this episode I wanted to focus on the regulatory environment that is going to be facing veterinary compounders.  Wendy is a wealth of knowledge on those and she also tells us great stories that include patient safety, and by patient I mean animal as well as pharmacist liability.  This is our first conversation with Wendy, stayed tuned for more as we do a deeper dive in regulations on future episodes.Support the show (https://www.buymeacoffee.com/pharmasalon)

Today  we are talking about hospitals vetting 503Bs.  I was speaking with Lou Diorio a few weeks ago and he mentioned that this is something that he is seeing hospitals struggling with. I just want to say that was recently speaking with someone during the course of my research into topics for this podcast and future conferences and this is one of the topics that came up so clearly Lou is onto something.Support the show (https://www.buymeacoffee.com/pharmasalon)

 In the Spring of 2021, several states added USP to their on-site inspections, catching pharmacies in those states off guard. At first, state inspectors were very lenient. But as 2021 was coming to an end, more state boards and inspectors became more stringent.So what are state board inspectors looking for?Join us to find out. This is part 1 of a 3-part series that will be ACPE Accredited for Pharmacists and Technicians. Support the show (https://www.buymeacoffee.com/pharmasalon)

Today we are talking about Lean Six Sigma. This is an important management and process improvement strategy and I thought it would be useful to cover some of the major principles. It can be applied to 503As, 503bBs and Hospitals.  This is part of a series that will be ACPE accredited when we are done.  At that point I will post a link to where you get a CE credit for listening if you are interested.Support the show (https://www.buymeacoffee.com/pharmasalon)

Guidance on Essentially a Copy for 503B Outsourcing FacilitiesLearning Objectives1.   Describe the decision tree to evaluate if a compounded preparation is essentially a copy.2.   Identify, when given a preparation, if the drug shortage exclusion applies.3.   Recognize, when given a preparation, if the Clinical Need exclusion applies.CE accredited for Pharmacists and Technicians. To get credits for this talk go https://compoundingce.com/courses/pharmasalon-guidance-on-essentially-a-copy-for-503b-outsourcing-facilities-evaluation/To watch the accompanying slides go to: https://youtu.be/XYK4OtB3MAsSelf-Assessment Questions  1. Your facility compounds a succinylcholine 20 mg/ml syringe both from API powder and sterile sourced vials. Succinylcholine is not on the FDA drug shortage list.a. The syringes made from either source are essentially a copy of the commercial product.b. The syringes made from both sources are essentially a copy of the commercial product.c. The syringes made from API powder are essentially a copy of the commercial product.d. The syringes made from sterile sourced vials are essentially a copy of the commercial product.2. An outsourcing facility compounds morphine 1 mg/ml syringes from API powder. These are available commercially in the same presentation.  However, morphine is currently on the drug shortage list and the syringes are on backorder.a. The syringes are not essentially a copy of the commercial product at this time.b. The syringes are always essentially a copy of the commercial product regardless of the drug shortage list.c. The syringes are not essentially a copy as long as there is a clinical need for Morphine.d. Morphine is a controlled substance and therefore must not be sourced from API.3. An outsourcing facility compounds preservative free rocuronium from API powder.  Rocuronium is available in preservative free form commercially and is not on drug shortage.  The facility asks you to check a box on its website stating that there is a clinical need for this product.a. The product can be sourced commercially and hence there is no clinical need for the outsourced product.b. The product is only available in vials, hence there is a clinical need for the product in syringes.c. It is the responsibility of the outsourcing facility to determine clinical need, so if they state there is a clinical need, it is okay to check the box.d. The box can only be checked by an OR physician.#compoundingpharmacy #compoundingpharmacists #compoundingpharmacies #pharmacists #pharmacytechnicians #pharmacytechniciansCE #pharmasalon#ACPE #pharmacyCEcredits #PharmacyCE #503b #essentialcopiesSupport the show (https://www.buymeacoffee.com/pharmasalon)

Welcome, today we are talking with Devin Wallace about the predicament many veterinary only compounders are going to find themselves in – which will be a situation similar to human compounding post 2012 – which is increased regulation and enforcement by a combination of the FDA, State Pharmacy Boards and Veterinary Boards. This is the beginning of a series for veterinary compounders and we will be covering topics related to CGMP,  regulations, USP 797 and USP 800.  Support the show

Over the past few months, I have been getting requests to talk about air and surface sampling for environmental monitoring programs. And with the release of USP 797 revisions there still isn't much guidance on choosing locations and your cant you can't sample every surface in your cleanroom; you have to choose strategic spaces. So, I thought I would go back to Abby Roth, and let her tell us the best ways to narrow down locations and develop a comprehensive sampling EM program.   Support the show (https://www.buymeacoffee.com/pharmasalon)

I am pleased to bring you this lecture by Kris Le from Amicus cGMP for organizations who want to expand their business and need to efficiently scale production.  The lecture covers ways to review methods to assess your current capabilities, understand how to determine barriers to scale evaluate ways to develop a production URS and learn how to improve systems for implementation and validation. For those of you who would like to follow along with the accompanying power point presentation this lecture is also available on our YouTube channel. The link is in the podcast description.To watch this lecture with the accompanying slide deck go to: https://youtu.be/q3v0Yx03l0gSupport the show (https://www.buymeacoffee.com/pharmasalon)

 Garbing and Behavior Considerations for Those Servicing USP 797 Customers Podcast with Abby Roth from Critical Point Nearly every certification company Abby has worked with has at some point had viable results come back from the lab that are off the charts. It may be something like 120 CFU/m3 of Staphylococcus, Micrococcus, and Corynebacterium species on a sample; and the counts are similar for all buffer and ante-room results. When you receive results like this, two thoughts will likely run through your mind. First, wow they are a mess! And second, oh wait, what if this was from us? You are going to have to share the results with the customer regardless of the cause. But first, you will want to determine if the exceeded results were due to poor garbing or behavior practices or sampling errors on your end. This way, when you discuss the results with your customer, you are prepared to share the corrective actions your organization is taking to prevent issues like this in the future.How to Integrate Compliance Procedures into Business Activitieshttps://www.buzzsprout.com/1794777/8670285How To Integrate Compliance Issues Into Business Activities: Part 2https://www.buzzsprout.com/1794777/8713586Support the show

In the last year or so there has been an explosion of the use of telehealth due to the pandemic. Along with that I've heard there are legal complexities for compounding pharmacies employing the technology.  I saw an article written by Emily Hussey from Reed Smith in Law 360 and I thought it would be great to go over the legal pitfalls and risks for compounding pharmacies.Support the show (https://www.buymeacoffee.com/pharmasalon)

This weeks episode is about perpetual versus continuous inventory. Carlos has seen a lot of problems and confusion with this. Pharmacists, Whether they are e doing dispensing with commercial or, or compound, it doesn't matter he says, they don't keep track of their control substances where they should, and its due to the confusing way the regulation is written. has caused me a lot of hand wringing. I really wanted to give you easily digestible information in 15-20 minutes but our conversation came out much longer. I tried to look at it and see how I could edit it down but there is so much good information I couldn't decide what to take out. I also wasn't able to break this down into 2 or 3 episodes as I  am able to do with some others.  So I am hoping that you have a nice long drive and have some time to dedicate to this episode. Support the show

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 rolesHow to Integrate Compliance Procedures into Business Activities Part1: https://www.buzzsprout.com/1794777/8670285How to Integrate Compliance Procedures into Business Activities  Part 2: https://www.buzzsprout.com/1794777/8713586Support the show (https://www.buymeacoffee.com/pharmasalon)

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. Support the show (https://www.buymeacoffee.com/pharmasalon)

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. Support the show (https://www.buymeacoffee.com/pharmasalon)

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. Support the show (https://www.buymeacoffee.com/pharmasalon)

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)

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.Support the show

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 hereSupport the show (https://www.buymeacoffee.com/pharmasalon)

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 hereSupport the show (https://www.buymeacoffee.com/pharmasalon)

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.Support the show (https://www.buymeacoffee.com/pharmasalon)

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 playerSupport the show (https://www.buymeacoffee.com/pharmasalon)

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.Support the show (https://www.buymeacoffee.com/pharmasalon)

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 we are going to talk about quality assurance means quality built in, this is a lead-up to a longer discussion that we are going to have in our October event. I wanted to have this session because I think it is important to get the ball rolling on this topic and gain understanding of what this means to 503AsSupport the show (https://www.buymeacoffee.com/pharmasalon)

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 really important issue and I believe that 503A really need to start moving towards USP 800 compliance but need a realistic idea of the process and what that is going to cost them.  In addition to our conversation about t the budgeting issues I think one of my biggest takeaways was the need to work as a  unified team and have an experienced team leader.Support the show (https://www.buymeacoffee.com/pharmasalon)

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, plumbing, electrical or HVAC begin to even create a lab that is compliant. Then there's the point that USP 800 includes OSHA and NIOSH, and they are under the banner of the Department of Labor. Because at its core, USP 800 is about a labor problem. And if you don't spend any money, whether you're a hospital or community pharmacy, or even a doctor's office, and you're dealing with these drugs and not making improvements, you run the risk of an employee picking up the phone to OSHA and saying, I'm being wronged here. And that's when the fines start to fly. And then there's a piece I just learned about the involvement of CMS, the organization that controls Medicare and Medicaid, this is huge for hospital pharmacies, because non compliance is a real risk to that very important revenue stream and it could be cut off. If you're thinking that sounds like a lot of information, how are they going to touch on all that in 20 minutes? We're not. This is a long episode. So get a cup of coffee, some comfortable headphones, and let's begin.Support the show (https://www.buymeacoffee.com/pharmasalon)

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 drugs and protecting their supply chain potentially  through the implementation of block chain, so I was wondering if 503B manufacturers were thinking the same thing or doing anything in this space.  Support the show (https://www.buymeacoffee.com/pharmasalon)

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 these people see themselves partnering with 503As, and whether it was a partnership or an acquisition.Support the show (https://www.buymeacoffee.com/pharmasalon)

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 inspections, the topic he chose to kick off with his waste management of controlled substances. I was intrigued by this because it seems like an innocuous topic. Now I know what you're thinking, no, it's not. And you're right. That said, an organization can acknowledge the seriousness of something and not live up to those standards. And that is what Carlos is seeing.Support the show (https://www.buymeacoffee.com/pharmasalon)

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 to have a couple different sessions addressing this topic both from a technician side as well as the management side but I thought it would be really interesting to hear before then from technicians who had successfully redefined their roles. Support the show (https://www.buymeacoffee.com/pharmasalon)

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 misconceptions on the regulatory issues. Some are due to perceived GMP standards that they think a 503 a couldn't possibly attain. So I was really looking forward to this conversation. They've been working in this space for years and was able to shed light on how they got into this area, and what it's been like working on clinical trials with a variety of organizations.Support the show (https://www.buymeacoffee.com/pharmasalon)

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 challenges of meeting both regulatory and business objectives in the outsourcing facility space, and how to appreciate the significant regulatory obligations for 503B's, which has to be a consideration in almost every decision made by facility management? In this episode, we're going to conclude our conversation by discussing the interplay between state and federal regulatory issues, and how important that interplay becomes in a facility's business decisions.Support the show (https://www.buymeacoffee.com/pharmasalon)

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 particularly lucrative for Stanley Pharmacy.  They started out as a vendor and the relationship grew into a mutually beneficial partnership going beyond a typical buy/sell affiliation.Support the show (https://www.buymeacoffee.com/pharmasalon)

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 way to achieve full compliance. Of course that is a pipe dream and can never fully happen but after conversations with several industry leaders it appears that the best way to start is to begin by introducing business decisions into the regulatory planning. I spoke with Karla Palmer about this and she led a talk with Travis Leah from QuVa and Kimberly Kieffer from Empower about the challenges of meeting both regulatory and business objectives in the outsourcing facility space.  In this series we have two episodes. In this one we are considering the question of why -- in the compounding space in particular -- how compliance and important compliance decisions must be fully integrated into the business activities of the company and how to go about integrating compliance procedures into business activities?  Our next episode will address the interplay between state and federal regulatory issues, and how important that interplay becomes in a facility's business decisions.Support the show (https://www.buymeacoffee.com/pharmasalon)

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 explore during this series is the idea of looking outward to grow. By that I mean, exploring partners and opportunities that may not be part of your core business.  The first person I spoke with about this is Greg McKetrick from Stanley Pharmacy. Through this series he took me on a journey of how he successfully embraced business relationships to create new partners  ranging from doctors to suppliers. Relationships and a level of trust has opened up not just new opportunities in traditional pharmacy/client/customer relationships but entire new revenue streams that were never even dreamed of when Stanley Pharmacy was founded Support the show (https://www.buymeacoffee.com/pharmasalon)

This month Renee talks about new ideas for expanding your downline. If you are in Direct Sales, or even your own home-based business that is trying to expand you dont want to miss these new rules of recruiting.

Co-Founder Vivian Juter Frankel blogs about life while trying to raise a business and a family. Do you see the occasional humor or do you sometimes just want to cry?

Idea Radio is brought to you by Moms Making Money. Listen to these women talk about their businesses and opportunities and find one that is right for you!

You've seen her. You know her. You started your business with her in mind (secretly of course). How can you become the successful entrepreneur that you see other people have.

Listen to how Farah Zweig started her business T.O.T Fitness

Audio blog from Vivian Juter Frankel, founder of Moms Making Money

This is a new monthly column Every Day Life from Renee Walton, President of Moms Making Money. Every month Renee will talk about the issues of being a work at home mom. Be sure to check out this month, The Top 5 Misconceptions of Being a Work At Home Mom.

This interview is with Janiece Go To Talent Management, a talent management agency specializing in kids. Janiece tells us how she, successfully runs her talent management business, entertainsclients, runs a theatre and a spends time with her 1 yr old daughter. Dont miss this interview. You will find yourself inspired by the success story of Janiece and other moms, coming soon, in this series.

Tip #1 from my audio blog. How to manage family and work. When things don't go the way you expect, don't worry.