What 503A compounders can learn from 503Bs
6 Steps to an ‘A’ Grade In Sterile Compounding E stablishing a 503B sterile compounding facility isn’t for every hospital with a compounding pharmacy. The differences between the requirements for compounding under Section 503A of the Drug Quality and Security Act and Section 503B are fairly large. Most hospitals have 503A compounders, which are traditional, small-batch compounding pharmacies, making shortdated preparations for specific patients per prescription or in very limited quantities. They’re governed by state board of pharmacy regulations and USP General Chapters <795> and <797>. In contrast, because 503B facilities make more complex products that are designed for longer beyonduse dating (BUD), they must comply with much stricter federal standards, dictated by the Code of Federal Regulations Title 21, which governs the FDA—specifically Part 210 on Current Good Manufacturing Practice (CGMP) guidelines. Qualifying and maintaining a 503B facility is a big responsibility to take on. “We get a lot of questions from hospital pharmacies about starting up their own facility,” said Bret Snow, PharmD, the director of pharmacy for Advanced Compounding Solutions at New England Life Care, in Woburn, Mass. “Some people see it as a revenue generator, some as a buffer against shortages. But the startup time alone is significant. Construction might be 36 months, commissioning six months, BUD studies 12 months. It could easily take four years just to get a 503B up and running.” Perhaps nothing exemplifies the difference between 503A and 503B facilities more than the recent delays in release and implementation of USP Chapter <797>. “For years, they’ve been trying to release the latest iteration of <797>,” Dr. Snow noted. The effective date of Dec. 19, 2019, for Chapter <797> was postponed, pending an appeal, a delay that also meant that the new Chapter <800> on handling of hazardous drugs in health care settings also remains informational only until <797> goes into effect. “You can’t act on it, because you don’t know what it’s going to be. But under CGMP, you don’t wait for anybody to tell you that something is a good idea. You’re pushing the highest quality all the time, being innovative and using technology to do so.” Consider something as simple as purchasing sterile gloves. A 503B compounding facility can only accept materials from qualified vendors, who are pre-verified to hold the same
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A technician labels syringes at a 503B facility run by Advanced Compounding Solutions at New England Life Care, in Woburn, Mass.
quality standards as the facility itself. Dr. Snow’s facility has a full-time employee who dedicates three full days per week to managing incoming material, ensuring everything is from a qualified vendor and documenting that it is all in good condition with an accompanying certificate of analysis. “Recently, with all the shortages of PPE [personal protective equipment], we were trying to get any sterile gloves that we could,” Dr. Snow said. “But we had to work with qualified vendors, and it takes time to qualify them. So we’d find these sterile gloves and told the quality department to get them and put them in quarantine. If we were able to qualify them later, we could use them, whereas with a 503A, you can get just about any garbing supplies from any vendor.” But even though many hospitals and health systems
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