04-18-2017 10:08 AM
I have read online an article that mentions the fact that when a pharmacy batches more than 25 items (anticipatory compounding) it is considered high-risk compounding. Not sure if the new USP 797 regulations address or clarify this, however, the risk levels in the new USP 797 are now classified as category 1 or category 2 CSP's and the BUD is based on whether or not a sterility test is performed. The low/medium/high risks levels will not longer be applicable for the BUD assignment. If a pharmacy needs to aliquot , foe example: 50 syringes from a single dose vial, is this now considered high risk because it exceeds 25 syringes?
Any thoughts or feedback are appreciated.
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04-21-2017 02:42 PM
Can you share this article you are referring to re: batching more than 25 is high-risk? That number only applies to the # of high-risk level CSPs when sterility testing is required. The FDA published draft guidance(see attached article) that allows you to batch up to a 30-day supply based on usage. A CSP is only considered high-risk when you use non-sterile ingredients or non-sterile equipment. Category 1 and 2 are NOT official yet and the USP Compounding Expert Committee will be issuing another revision sometime this year for public comment. It is business as usual until the chapter is revised and official or unless you live in California (new sterile regs that became official on Jan 1, 2017. Hope this helps.