Becker's ASC Review

34 Executive Briefing Sponsored by: O utsourcing facilities, which were developed following passage of the Drug Quality and Security Act of 2013, present an important opportunity for ASCs to boost the quality and efficiency of their care. However, it is important to select a 503B outsourcing partner with the right experience and expertise to reliably support ASC needs. Below, Fagron Sterile Services President Carl Woetzel, Global Quality Director Jason McGuire, and Vice President of Operations Jason Winfield outline key considerations for ASCs as they select outsourcing facility partners. Question: What is a 503B outsourcing facility? Carl Woetzel: Outsourcing facilities are a relatively new creation that provide a necessary element in the patient care continuum. These facilities fit in perfectly between traditional pharmaceutical manufacturers and traditional pharmacies to serve provider and patient needs by preparing and distributing drug products that are not otherwise commercially available. Outsourcing facilities strictly adhere to FDA regulatory standards, called current Good Manufacturing Practices (cGMP), in a manner that is very similar to a pharmaceutical manufacturer. Outsourcing facilities fulfill a market need because they provide the safety and reliability of a drug manufacturer but can take a much more nimble approach to creating customized options for their customers. Jason McGuire: Upon the development of the Drug Quality and Security Act in 2013, the FDA created the new section 503B which defines an outsourcing facility's role and responsibility for producing pharmaceutical products. Under the new law, a 503B outsourcing facility was given the exclusive opportunity to manufacture drug products that are not commercially available from traditional pharmaceutical manufacturers. The focus of the law is on how the facility maintained and followed applicable cGMP and best practices, especially as it relates to aseptic processing and the necessary critical control parameters. Jason Winfield: This new 503B designation increased the level of quality and compliance associated with the manufacturing facilities, processes and practices. By creating outsourcing facilities, Congress gave hospitals and other facilities the opportunity to safely outsource manufacturing services associated with the sterile production of injectable and parenteral medicines. Q: How can a reliable 503B outsourcing partner bring stability to ASC supply chains? CW: A reliable 503B outsourcing partner such as Fagron Sterile Services stabilizes ASC supply chains by ensuring that the medications needed are always in stock and ready to ship. This is best done through a supply agreement where drug manufacturing production is based on projected and historical demand levels with a margin for seasonal adjustments. Additionally, new products can be identified and added to the 503B's portfolio based on the needs of the ASC. JW: Fagron's products are delivered in sterile, ready-to-use presentations with labels meeting ISMP standards, eliminating the need for pharmacist, nurse, or other practitioner manipulation. Some examples include: separating multi-dose vials into single syringes, aspirating from glass vials or ampules into a syringe, and reconstituting lyophilized powders with sterile diluents. All Fagron products undergo extensive sterility and stability protocols and testing to ensure the sterility, quality, and potency from receipt of the product and through the products shelf life. Q: Should an ASC choose sterile-to-sterile or API-to-sterile compounding? CW: This often comes down to customer preference. However, I believe there are several advantages to API-to-sterile compounding. For instance, drug shortages often affect the availability of a medication needed in an ASC. If an ASC chooses to partner with a 503B that prepares drug products from API, the likelihood of experiencing supply interruptions in the face of a drug shortage can be reduced. We have seen this recently with the unavailability of sedatives and muscle relaxants for COVID-19 patients requiring mechanical ventilation. Drug manufacturers and sterile-to-sterile outsourcing facilities have not been able to supply market needs, whereas API-to- sterile outsourcing facilities have been successful in providing those needed drug products. Another advantage is that the API-to-sterile manufacturing process is more efficient and requires fewer steps. 503Bs that only perform sterile-to-sterile compounding are required to purchase finished pharmaceutical goods which have been manufactured by a pharmaceutical company, shipped to a wholesaler, ordered by the 503B, and then repackaged and sold to the customer. The sterile-to-sterile compounding process requires more manipulations and is less efficient than API-to-sterile compounding. While both sterile-to-sterile and API-to-sterile compounding processes result in the production of safe products, we believe that the safety, efficiency, and invulnerability to drug shortages inherent in API-to- sterile compounding renders it a worthwhile choice for ASCs. JW: Hospitals and ASCs should prefer and expect their 503B partners to offer, or at least have available, an API-to-sterile presentation component in their portfolios. Sterile-to-sterile compounding requires sourcing of vials or ampules of manufactured finished drug products, which generally will drive costs higher and result in lack of availability during drug shortages. API-to-sterile compounding is safe and effective. Any suggestion to the contrary is simply untrue. • API is sourced from FDA registered vendors, who are audited by Fagron on a regular basis. Additionally, all APIs are qualified and tested in accordance to their USP monograph prior to release for use in the commercial manufacturing process. • Manufacturing processes are engineered, validated, and proceduralized for robustness and consistency. Every detail of the process is defined in Standard Operating Procedures (SOPs), as well as Master Batch Records (MBRs) which are unique for each process. SOPs and MBRs are followed and any deviation from these processes results in a deviation investigation to determine root cause and impact prior to batch disposition. • The manufacturing environment is continuously monitored and people are routinely monitored on a batch-specific basis. • All batches are sterile filtered, and filter integrity tests confirm successful terminal filtration. • Each batch undergoes rigorous quality inspection, critical system How Ambulatory Surgery Centers (ASCs) Can Benefit from Pharmaceutical Outsourcing Facilities: 8 Questions Answered

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