The Future of 503B Pharmacies: An Interview With Syed Saleem

Narrator: This is the DarshanTalks Podcast. Regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at darshantalks.com. Darshan: Hey, everyone. Welcome to another episode of DarshanTalks. We have a really special guest with us. We have Syed Salim and Syed is... Syed, why don't you actually introduce yourself? Syed: Wonderful. Thanks Darshan. Thanks for having me. My name is Syed Saleem. I am a pharmacist. I hold a doctorate of pharmacy and an MBA. I have a pharmacist license active in 24 States, United States. I also have some of the certifications, Six Sigma, Project Management, pharmaceutical specialist and a few other. I do have a vast background in the compounding industry and the regulatory and compliance. And also formulation's, including 503A, 503B. I've been in the company industry prior to the DQSA, that is the Quality Safety Act, which came in around 2013. So I do have a wide range experience touching into production side of manufacturing, retail, hospital. Yeah, all those. Darshan: So a really simple question, cause I have to ask this because, like you know, I'm a pharmacist as well. But you said you have licenses in 24 States, is it? Syed: That is correct. Darshan: So how difficult is it to maintain that? Syed: It is pretty tedious because every state has their own CEs to be... certain CEs. Like some States do require you having a pain management sees CEs some States require your sterile compounding, non-sterile compounding. Each of these States has their own requirements. And I have to tell you, I have a good spreadsheet and then I do have reminders and yeah. A few of those tools. Yes. Darshan: Have you found that to be useful in the compounding world? Syed: Sure it is, because... And again, the regulatory requirements does need a pharmacist to be licensed onsite to have these licenses in those particular States. So for that reason, a pharmacist needs to have the licenses in those States. If the pharmacy or the 503B outsourcing facility need to do business in those particular States. Darshan: So, if that's true, do you lined up at... Tell me about the type of work you do Syed. Syed: Sure. I'm a pharmacist in charge/director role at the 503B facility, which also has a 503A though. So we hold a 503B FDA registered facility and also a pharmacy. But majority, I think that most of the business is on the 503B sides. We comply with our 503B requirement, which is basically following all the CGMP, following all the CFRs. So it is pretty strict and it is well beyond the 797 requirements. So we need to have... it's like a mini pharma manufacturing, wherein we have a quality department, which is a completely independent. With their quality control quality assurance, a quality unit, with a quality manager who looks after that. Then we have a regulatory compliance department and then we have a production operations. So it's very organized. It's not a typical pharmacy or compounding pharmacy, which used to be before, we are evolving towards manufacturing. So this facility we are, we build it brand new. I know a lot 503Bs struggle to transition from the old compounding pharmacy, but this facility, we had to build the ground up. Right from the DQ, it's design qualifications. Having all the instruments validated. I mean, pretty much everything what we do here represents a pharma manufacturing in a mini scale. Darshan: That's the real question, right? So everyone talks about how 503Bs are pharmacies, and you talk about how they're really many manufacturing companies, or mini manufacturers. What is the distinction as you see it? What are the big mistakes people make?