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The Bottom Line Pharmacy Podcast: Sykes & Company, P.A. - Legal Updates Impacting 503A and 503B Pharmacies Featuring Brad Howard and Michael Alexander

Legal Updates Impacting 503A and 503B Pharmacies Featuring Brad Howard and Michael Alexander

12/12/24 • 38 min

The Bottom Line Pharmacy Podcast: Sykes & Company, P.A.

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The 503A and 503B legal landscape is ever changing and staying on top of these changes can be tedious.
But don’t worry! Sykes is here with the trustee colleagues at Brown & Fortunato.
On this episode of the Bottom Line Pharmacy Podcast, Scotty Sykes, CPA, CFP® and Bonnie Bond CPA, sit down with Brad Howard, Esq. And Michael Alexander, Esq. From Brown & Fortunato share recent changes to the 503A and 503B regulatory landscape including:

  • The Evolving relationship between 503B and 503A pharmacies
  • Impact of FDA regulations and state-level inconsistencies
  • Possible changes coming in 2025

More about our guest:
Brad Howard:
Bradley W. Howard is a health care attorney with extensive experience representing pharmacies, durable medical equipment providers, hospitals, and many other health care providers with compliance, enforcement, and litigation matters throughout the country. Brad enjoys working with pharmacies and other health care providers on regulatory and contractual compliance matters, payer and PBM audits and appeals, governmental demands and requests, responses to subpoenas and demand letters, and business disputes including litigation. Brad routinely handles health care investigations by the Department of Justice, HHS OIG, various boards of pharmacy, State Attorneys General, the Department of Defense, and other regulators.
Michael Alexander:
Michael represents health care clients in a variety of business and regulatory matters, including regulatory compliance, licensing, due diligence review in the acquisition of health care providers, government investigations, and commercial disputes. Michael’s clients are primarily pharmacies, hospitals, and physician groups, but he also assists many other health care providers. Michael has successfully assisted his clients in resolving government investigations on both the state and federal level involving general compliance issues as well as matters related to fraud, waste, and abuse. He has also represented clients in payor disputes, and worked in conjunction with his clients, co-counsel, and other parties to coordinate the simultaneous acquisition and re-licensure of multiple health care providers.
Learn more about the Brown & Fortunato Team:
Brad Howard LinkedIn
Michael Alexander LinkedIn
Brown & Fortunato Website
Brown & Fortunato Facebook
Brown & Fortunato LinkedIn
Connect with us on social media:
Facebook
Twitter
LinkedIn
Scotty Sykes – CPA, CFP LinkedIn
Scotty Sykes – CPA, CFP Twitter
Bonnie Bond – CPA LinkedIn
Bonnie Bond – CPA Twitter
More resources on this topic:
Podcast – Developing a Weight Loss Program with GLP1s in Your Pharmacy
Podcast – Driving Independent Ph

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Send us a text

The 503A and 503B legal landscape is ever changing and staying on top of these changes can be tedious.
But don’t worry! Sykes is here with the trustee colleagues at Brown & Fortunato.
On this episode of the Bottom Line Pharmacy Podcast, Scotty Sykes, CPA, CFP® and Bonnie Bond CPA, sit down with Brad Howard, Esq. And Michael Alexander, Esq. From Brown & Fortunato share recent changes to the 503A and 503B regulatory landscape including:

  • The Evolving relationship between 503B and 503A pharmacies
  • Impact of FDA regulations and state-level inconsistencies
  • Possible changes coming in 2025

More about our guest:
Brad Howard:
Bradley W. Howard is a health care attorney with extensive experience representing pharmacies, durable medical equipment providers, hospitals, and many other health care providers with compliance, enforcement, and litigation matters throughout the country. Brad enjoys working with pharmacies and other health care providers on regulatory and contractual compliance matters, payer and PBM audits and appeals, governmental demands and requests, responses to subpoenas and demand letters, and business disputes including litigation. Brad routinely handles health care investigations by the Department of Justice, HHS OIG, various boards of pharmacy, State Attorneys General, the Department of Defense, and other regulators.
Michael Alexander:
Michael represents health care clients in a variety of business and regulatory matters, including regulatory compliance, licensing, due diligence review in the acquisition of health care providers, government investigations, and commercial disputes. Michael’s clients are primarily pharmacies, hospitals, and physician groups, but he also assists many other health care providers. Michael has successfully assisted his clients in resolving government investigations on both the state and federal level involving general compliance issues as well as matters related to fraud, waste, and abuse. He has also represented clients in payor disputes, and worked in conjunction with his clients, co-counsel, and other parties to coordinate the simultaneous acquisition and re-licensure of multiple health care providers.
Learn more about the Brown & Fortunato Team:
Brad Howard LinkedIn
Michael Alexander LinkedIn
Brown & Fortunato Website
Brown & Fortunato Facebook
Brown & Fortunato LinkedIn
Connect with us on social media:
Facebook
Twitter
LinkedIn
Scotty Sykes – CPA, CFP LinkedIn
Scotty Sykes – CPA, CFP Twitter
Bonnie Bond – CPA LinkedIn
Bonnie Bond – CPA Twitter
More resources on this topic:
Podcast – Developing a Weight Loss Program with GLP1s in Your Pharmacy
Podcast – Driving Independent Ph

Previous Episode

undefined - Pharmacy Insights: PBM Updates, Tax Tips, and Thanksgiving!

Pharmacy Insights: PBM Updates, Tax Tips, and Thanksgiving!

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Happy Thanksgiving from Sykes!

To help you celebrate this holiday, we’re bringing you a special bonus episode of The Bottom Line Pharmacy Podcast!

In this episode, Scotty Sykes, CPA, CFP and Bonnie Bond, CPA discuss various topics ranging from trade show experiences to Thanksgiving preparations.

Highlights include:

  • Insights from recent pharmacy trade shows
  • Updates on pharmacy regulations
  • Tax tips for the upcoming year
  • And more

Did you like this episode? Stay up to date on new episodes by liking and subscribing!

Stay Connected With Us On Social Media

Facebook
Twitter (X)
LinkedIn
Instagram

Scotty Sykes – CPA, CFP LinkedIn

Scotty Sykes – CPA, CFP Twitter

Bonnie Bond – CPA LinkedIn

Bonnie Bond – CPA Twitter


More Resources on This Topic:
Schedule an Rx Assessment

Podcast – PBM Audit Masterclass

Podcast – Master the Margin: Fundamentals of Pharmacy Accounting

Podcast – Understanding BOI Reporting

Podcast – Master the Margin: 2025 Tax Cuts and Jobs Act Changes

Next Episode

undefined - Navigating the Pharmacy Marketplace Featuring Wade Hinkle, Founder and CEO of Pharmacy Market Place

Navigating the Pharmacy Marketplace Featuring Wade Hinkle, Founder and CEO of Pharmacy Market Place

Send us a text

Buying from primary vs. Secondary wholesalers, when is it best for your pharmacy and how does it impact your bottom line?

In this episode of The Bottom Line Pharmacy Podcast, Scotty Sykes, CPA, CFP, Bonnie Bond, CPA, and Ollin Sykes, CPA, CITP, CMA sit down with Wade Hinkle, Founder and CEO of Pharmacy Market Place to discuss:

  • Optimizing pharmacy operations through technology
  • Inefficiencies in traditional pharmacy purchasing methods
  • Importance of balancing primary vendor agreements with secondary market opportunities

And more!
More about Wade Hinkle:
Wade Hinkle is the Founder and CEO of Pharmacy Marketplace, an all-in-one purchasing solution that considers primary vendor agreements and key metrics to help you make better real-time purchasing decisions.
Prior to Pharmacy Marketplace, Wade studied at the University of Auburn where he obtained a degree in finance. This degree ultimately led him to become a partner and Owner of Hinkle Pharmacy in Alabama where he later used the insights he learned in owning a pharmacy to Co-found Inventory IQ, a service based business focused on helping independent pharmacies implement perpetual inventory systems.
Stay connected with Wade on social media:
Wade Hinkle LinkedIn
Pharmacy Marketplace Website
Pharmacy Marketplace Facebook
Pharmacy Marketplace LinkedIn
Stay connected with us on social media:
Sykes & Company P.A.:
Facebook
Twitter
LinkedIn
Scotty Sykes – CPA, CFP LinkedIn
Scotty Sykes – CPA, CFP Twitter
Bonnie Bond – CPA LinkedIn
Bonnie Bond – CPA Twitter
More resources on this topic:
Podcast – Improving Cash Flow With Inventory Management
Webinar – Maximizing Your Largest Expense: Inventory
Webinar – Inventory Management: Keep Cash In the Bank, Not on Your Shelf
Webinar – Improving Cash Flow Inventory Management Best Practices

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