Issue link: https://beckershealthcare.uberflip.com/i/1252329
35 Executive Briefing confirmation, sterility, potency and other required compendial testing which is product-specific. • Quality and aseptic processes are routinely monitored to confirm adherence to all site procedures. Q: How can 503B outsourcing reduce an ASC's regulatory burden? CW: Much like all healthcare facilities, ASCs are subject to ever- increasing regulatory requirements. These requirements include measures aimed at ensuring the safety and effectiveness of medication use. Medication use includes ordering, compounding, labeling, administering and documenting. A 503B can help to alleviate some of the regulatory burden by providing customized, convenient, safe and effective medication in ready-to-use containers. Medications that come from a 503B to an ASC are labeled pursuant to ISMP standards with labels that are easy to read and color coded to ensure medication safety, particularly in high-acuity situations. Medications obtained from a 503B also eliminate the need for providers to compound medications on-site, sometimes in less-than- ideal conditions for aseptic manipulations. Instead, providers can simply administer the ready-to-use medication directly. JM: The ASC auditing bodies are verifying their vendors maintain the necessary compliance standards. So long as we keep our house in order, then it makes it easier for ASCs to respond to questions in the event of audit at their site. JW: If properly managed, a significant portion of regulatory burden can be leveraged onto the 503B. Our sites are inspected annually, and sometimes semi-annually, by FDA, DEA, and various state boards of pharmacy. In addition, we host not less than 15 to 20 customer audits and inspections throughout the year and are subject to internal quality audits by both department and job function. Q: 503B suppliers must comply with all FDA and DEA quality regulations to operate, but what should ASCs expect from a top- tier 503B partner? CW: A top-tier 503B partner will have an impeccable safety record. They will have a quality program that ensures that all medications are extensively tested before being shipped to their customers. They will have excellent customer service and a portfolio of products that fit the needs of an ASC. A top-tier 503B will also ensure that all medications needed by the ASC are always stocked and ready to ship. They are able to fulfill orders within a day and offer rapid shipping options. JW: Fagron maintains a greater than 97 percent fulfillment rate, meaning that more than 97 percent of the time an order is placed that order is filled the same day. Organizations that experience recurrent unexpected delays in shipping, batch rejections that impact fulfillment rates, or frequent finished goods inventory shortages is a signal of lack of operational discipline and poor quality in operations. Q: What are the advantages of a 503B in-house quality testing lab versus outsourced testing through a third party vendor? CW: There are advantages to a 503B having its own in-house quality control lab. The most significant benefit that an in-house lab provides is additional control over quality. This includes the ability to develop robust procedures and conduct thorough investigations when necessary. Additional benefits include cost and turnaround time. When a 503B tests their own products, they avoid the additional costs of outsourced lab testing and can pass that savings on to the customer. They are also able to release commercial batches faster, resulting in quicker customer access to needed medications. Typically, testing samples can be delivered and put on test the same day they are received in- house, as opposed to a contract lab which requires shipping and may experience other delays. JM: The most critical advantages revolve around regulatory, speed to market, and on-time delivery to ASCs and other customers. The FDA and other auditing bodies appreciate having quality control data and access to the lab when they are on-site. When using an outsourced laboratory, there can be communication challenges and delays in obtaining requested information. Additionally, outsourced labs can run into issues with their own inspections, which may create problems for 503B facilities and their customers. Regarding speed to market, we have the ability to prioritize which test methods need to be developed sooner without being beholden to the often-long queues at the outsourced lab. In some cases, we can save months in bringing a product online for our customers. Q: What are the three most important criteria for an ASC to consider when choosing a 503B outsourcing partner? CW: Quality and reputation in the industry; this is the most important aspect, because the quality of care at the ASC is affected by the quality and safety of its medications. Reliability of supply; this is important as well. You need to be able to count on your 503B partner to produce the medications you need when you need them. Customer Service; when you place an order or make a phone call, how are you treated? Is the process easy and straightforward? JW: I would also add honesty and transparency, specifically, with business ethics and quality operations. Do what you say, and say what you do – interestingly, this is also a fundamental of cGMP. Additionally, cGMP experience and subject matter expertise with 21 CFR Parts 210 and 211 are crucial. Fagron has purposefully hired expertise in cGMPs and sterile pharmaceutical manufacturing, quality operations and technical services to uniquely position us to support hospitals, health systems and their leadership in delivering cost-effective, high-quality and reliable ready-to-use sterile injectables. Q: What are the advantages of 503B outsourcing versus compounding in-house? JM: There are several advantages to outsourcing from 503Bs. The first is a reduced risk profile. Compounding is as much science as it is art. You need to understand product development, process qualification, and most importantly how to train individuals to be qualified to operate in an extremely controlled environment. Second is consistency. When using an outsourcing facility, most likely they are producing thousands of the same units daily or weekly. Therefore, they know intimately how to maintain the necessary critical process parameters to ensure each batch is produced the same way with the highest quality control. CW: I believe that partnering with outsourcing facilities improves the safety and reliability of medication use and optimizes the use of health system, hospital and ASC resources. Patient safety is enhanced using ready-to-use products with enhanced labeling, extended dating that is backed up by real data, tailored and individualized dosing, and extensive product testing before release. The utilization of resources is optimized by eliminating medication preparation and compounding steps for hospital and ASC staff. n Fagron Sterile Services US (FSS) is a 503B Outsourcer with industry leading state-of-the-art facilities and in-house quality testing labs – centrally located in Wichita, KS. FSS specializes in compounded sterile preparations for acute care hospitals, ambulatory surgery centers and clinics. Anesthesia, Ophthalmics, Pain Management and specialty products for Dialysis and Urology.