Shots: 

• Compounding pharmacies can help significantly by providing customized medications tailored to individual patient needs, bridging the gap in medicine delivery during a drug shortage, and enhancing accessibility.  

• Today, at PharmaShots, we have Mark Mikhael, CEO of Olympia Pharmaceuticals, an FDA-registered 503B outsourcing facility. 

• Currently licensed in 47 states of the US, Olympia hosts two state-of-the-art facilities: 503B and 503A. 

Saurabh: Would you mind shedding light on Olympia Pharmaceuticals (products & services, etc.) for our readers?  

Mark: Olympia Pharmaceuticals, an FDA-registered 503B outsourcing facility, provides premium quality compounds across the nation. With two state-of-the-art facilities—503B and 503A—Olympia offers medications for both office use and individual prescriptions. We specialize in IV nutrition, erectile dysfunction, age management, men’s and women’s health, weight loss, sexual health, dermatology and more. 

Saurabh: Could you elaborate on 503A and 503B outsourcing facilities? 

Mark: The key differences between a 503A and 503B pharmacy come down to quality and regulations. With both a 503A pharmacy and 503B outsourcing facility under the Olympia name, we’ve set the gold standard for quality and regulatory excellence across the compounding industry. Traditional 503A pharmacies compound patient-specific medications under state oversight while following USP guidelines. In general, 503A pharmacies have less regulatory oversight and testing requirements for their medications. Although they’re not required to meet the same cGMP (current good manufacturing practices) guidelines as a 503B facility, Olympia’s 503A and 503B locations operate at the same cGMP level, ensuring all our medications are consistent in quality, safety and precision. 

The FDA created the 503B designation to establish a new level of patient care and safety, and Olympia’s outsourcing facility adheres to the guidelines and principles they have set. Outsourcing facilities must comply with strict cGMP guidelines, which are the same standards that pharmaceutical manufacturers follow. These large-batch manufacturing facilities are now the ONLY pharmacies permitted, under the new law, to provide compounded medications for use in physicians’ offices, clinics, and hospitals. Because the new rules are so stringent, only a handful of compounders in the United States have elevated their pharmacies to the new FDA outsourcing facility designation. Olympia is the only outsourcing facility located in Central Florida.   

Saurabh: How do 503A and 503B Compounding Pharmacies help increase patient access to necessary medications, improving public health and safety?  

Mark: There are many ways in which these designations are vital to public health and safety. First, 503A pharmacies allow patients to receive custom medication at an affordable price. If a patient has an allergy to an ingredient found in a commercially available drug, a 503A pharmacy can compound the medication for that patient while accommodating their medical needs, bridging a gap that may have existed. In addition to tailored compounding, 503A pharmacies can assist in compounding items listed on the FDA’s 503A bulk list.  

503B outsourcing facilities offer a different, yet vital, advantage to the public’s health. These operations follow stricter manufacturing protocols and are under both federal and state oversight to allow for large-scale production and distribution. 503B facilities are authorized to compound medications listed on the FDA’s drug shortage list, helping expand patient access and ensuring there is not a lapse in treatment for patients affected by a shortage. The compounded versions are often sold at a much lower cost than the brand name drug, allowing for even higher patient access. On top of this, 503B outsourcing facilities can compound medications listed on the FDA’s 503B bulk list.  

Saurabh: How does Olympia help support both patient-specific and office-use needs? 

Mark: By offering both 503A and 503B compounding pharmacy capabilities, Olympia can meet both patient-specific and office-use needs across the U.S.  

Saurabh: Would you mind highlighting the key benefits of Compounding Pharmacies and how Olympia strengthens the ability to provide relief to patients during ongoing nationwide drug shortages?  

Mark: Traditionally, compounding refers to the practice of creating personalized medication intended for patients unable to use mass-produced medicines. Whether it’s an allergy to commonly used medicine fillers, an inability to swallow pills, or another similar issue with mass-produced medication, a compounding pharmacy is designed to help resolve those issues by customizing their products to suit individual patient needs. 

Today, compounding pharmacies are also used to help during drug shortages. Because these shortages can last for months or even years, compounding pharmacies have played a crucial role in helping lower the impact on patients by supplying the medication at stake. During a drug shortage, 503B pharmacies may step in to help boost productivity and increase the availability of medications affected by the shortage. 

Saurabh: Are you planning to expand the inventory of compounded chemicals and traditional medications in other countries or counties? 

Mark: We are currently licensed in 47 states and are always looking for avenues to foster expansion. As our industry continues to grow, I would not be surprised if we started to explore further opportunities.   

Saurabh: Do you plan to collaborate with any other companies to enhance your company services? 

Mark: Olympia is actively collaborating with several recognizable names in the weight loss arena that share our mission to increase affordability and patient access to life changing medications. We are excited to grow our footprint in this industry through these key partnerships.  

About the Author: 

Mark Mikhael 

Mark Mikhael, Chief Executive Officer of Olympia Pharmaceuticals, demonstrates a wealth of expertise in fostering change for the pharmaceutical industry. Utilizing over two decades of pharmaceutical experience in his role, Mikhael is a mainstay of Florida’s pharmaceutical scene. He is actively involved in the Florida Board of Pharmacy and is an advocate for patient safety in the compounding industry. Mikhael previously served as Chief Pharmacy Officer for CarepathRx and ProHealth Pharmacy Solutions. His operational know-how and patient-focused approach will serve as major benefits for the future of Olympia.  

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