Issue link: https://beckershealthcare.uberflip.com/i/827052
24 Executive Briefing Transitioning from the mom-and-pop "apothecary houses" of yesteryear to sterile drug manufacturing standards With heightened compliance requirements comes the need for personnel trained in sterile drug manufacturing, robust facility designs, testing equipment and instrumentation and, above all, definitively sound sterility assurance practices. Although registra- tion as a 503B outsourcing facility may be an option for some willing to adopt the more stringent regulatory regime, it is not without its challenges. According to Andrew Harrison, "The fi- nancial impact of becoming a cGMP-compliant 503B outsourc- ing facility can be truly staggering for a small to mid-size phar- macy contemplating [503B] registration. Supposed "turn-key" compliance solutions may not address applicable components of 21 CFR 210/211 or fail to incorporate key procedural and en- gineering controls for compounded drugs produced by aseptic processing. Prior experience in the regulated industry, particu- larly in sterile parenteral drug manufacturing, is a near-must." While healthcare providers are able to include immediate-use compounding as an in-house function, most in-house compound- ed admixtures have a short shelf-life and can quickly contribute to waste and staff diversion from patient-care focused activities. Ad- ditionally, most in-house compounding facilities are not designed to achieve maximum throughput efficiency, sometimes taking weeks to deliver testing outcomes (i.e. sterility testing results) that certain outsourcing facilities can provide within hours due to their use of advanced testing instrumentation and industry-rec- ognized rapid methods. Lastly, current draft guidance for industry furnished by the FDA would operate to restrict the way hospitals and health systems may distribute in-house compounded sterile preparations to their patients. Outsourcing facilities, by virtue of their commitment to good manufacturing practices, are not simi- larly restricted. Other factors, such as the need for large quantities of ready-to-use sterile preparations frustrate the purpose of in- house compounders, particularly when space and facility design considerations are considered. "Some of the larger outsourcing facilities have acted to further reduce the human element in ster- ile compounding as an additional sterility assurance measure, opting instead to use process automation and robotics to pro- duce sterile preparations. This automation facilitates large order fulfillment while minimizing manual aseptic processing – the re- sult is scaled efficiency and maximized patient safety." Insurance companies are also paying more attention to quality scores and demanding their members receive high-quality care for a reasonable price. Although ASCs are already lower cost providers, many facilities suffer a financial squeeze between low reimbursement and ever-increasing overhead costs. Con- tracting to outsource sterile compounding needs may help the center realize additional efficiencies, eliminate waste, and miti- gate compliance risks. Primary considerations an ASC may have in deciding to out- source sterile compounding: • Ensuring the highest quality standards are employed in delivering safe compounded sterile preparations • Asking the intended outsourcing facility if they com- pound exclusively from FDA-approved sterile drugs in their finished dosage form or whether compound- ing occurs using non-sterile bulk drug substances • Resolving operational inefficiencies associated with in- house compounding • Ensuring compliance with state and national accrediting bodies • Maintaining practitioner focus on patient-focused care and away from compounding • Accessing additional benefits of professional phar- macy headcount mitigation and labor cost control • Reducing infrastructure costs associated with designing proper in-house compounding areas—minimizing or even eliminating remodeling costs and maintenance Not all outsourced sterile compounding pharmacies are the same and facilities could lose short- and long-term control over the deci- sions about and expertise in sterile compounding. These concerns underscore the need to thoroughly investigate the outsourcing facilities with which a healthcare provider intends to collaborate. After conducting an internal analysis, healthcare organizations that decide to outsource sterile compounding have several op- tions. The organization should lead a search for the appropriate sterile compounding partner based on the organization's needs and sterile compounding pharmacy's historical reliability, repu- tation, regulatory posture and overall product quality. The ster- ile compounding partner should hold register with the FDA as a 503B Outsourcing Facility, comply with all applicable require- ments, and most importantly, agree to adhere to current Good Manufacturing Practices. The FDA typically inspects facilities shortly after they open and on a risk-based basis thereafter, but that registration and inspection alone do not serve as an "approv- al" by the FDA of any given outsourcing facility. Providers should understand that an outsourcing facility has systems in place to sustainably adhere to all of the federal and state regulatory re- quirements, so seek out those 503B registrants that exhibit top- level service. For example, high quality outsourcing facilities will: • Have a strong culture for quality and compliance and be adequately resourced to discharge their regulatory responsibilities as producers of pharmaceutical products; • Not be subject to enforcement action by the FDA or state regulatory agencies; • Employ engineering controls that minimize sterility assur- ance risks such as: • Compounding solely from already approved sterile drugs in their finished dosage form, • Employing process automation over manual aseptic processing by humans where practicable, • Implementing measures for continuous monitoring of areas where aseptic manipulations of compound- ed preparations actually occur. • Not have record of product recalls due to any lack of ste- rility assurance relating to their products; • Implement a consistent and reliable ordering process, with on-demand customer service support; • Be transparent about the quality of their products and continuous improvement initiatives; • Support customer visits of their operations and provide an opportunity for dialogue with facility and corporate leadership n PharMEDium is committed to patient safety. We have four large-scale 503B Outsourcing Facilities registered with the FDA and state Boards of Pharmacy nationwide, with the primary goal of consistently delivering high quality sterile products. PharMEDi- um compounds exclusively from FDA approved sterile drugs in their finished dosage form and uses only FDA-cleared drug de- livery devices in its compounding process. Additionally, PharMEDium has a dedicated Customer Service Center and Customer Visit Program which offers in-depth tours of its facilities to foster transparency about its operations and quality processes.