Darshan: Here are the top seven professionals to have when starting your 503B compounding pharmacy. You want access to these people on a routine basis so that you can make smart decisions and grow your company. Number one, you want a CEO. A CEO might be you, might not be you. You want someone who can think strategically, someone who can think across different projects and go, "Where is the market going and how do I get ready for that market?"
Number two, you want to have a CPA, someone who's going to do your taxes, someone who understands your business and the type of capital expenditures you're making, and can advise you if now's the right time to do it or wait, or is something going to be considered an ordinary expense or it's going to be considered a capital expense, and what are the implications of that?
Number three, you want to have a lawyer. The lawyer is going to be someone who's going to be advising you, not only on what type of legal issues to comply with, but also the types of regulatory issues hopefully that you might have to comply with. And you might get lucky in that that person will be one in the same. In my case, obviously, I can do both, but not a lot of people can.
Your fourth one, in case you cannot find a lawyer who can do both, you probably need to have access to a regulatory person. How do you respond to a 483? How do you create a [inaudible 00:01:24]? Can you create the specific product or is it an on the FDA banned substances list? That's the kind of stuff that your regulatory person should be able to answer.
And your last one is having a marketing person. And pharmacists often think that if you open up a pharmacy, people will come to it. No, you probably need a marketing person. But marketing people are often very zealous, and you want to make sure that you control them, train them, make sure that they don't go beyond what they should be doing. So, you need to have the appropriate training and that's what your lawyer should hopefully help you with that.
So, we had a CEO, a CPA, a lawyer, a regulatory person, and marketing. Did you think I forgot a profession? Obviously, pharmacists will be included, but that's if you own your own compounding pharmacy. But if there's anyone else, feel free to reach out, maybe you even consider having a board of directors, but that wouldn't be a profession. But feel free to reach out or hit the like button. Thanks.
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.
