Not all specialty pharmacies operate a compounding line of business….. but there are a number of SPs that do. If your pharmacy is into compounding, then you should already be aware of the new standards that are going into effect on November 1st. If your specialty pharmacy isn’t into compounding, then read on regardless….. and learn something new about your industry.
The new standards are being published by the USP which stands for United States Pharmacopeia, an industry “bible” published annually by this now over 200-year old nonprofit organization. USP is not a regulatory body or an accrediting agency . Rather, USP is an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicine and works to strengthen the global supply chain. USP healthcare standards and solutions are practical tools that healthcare practitioners use to help ensure consistency in operations, foster timely decision making, and quality of patient care.
As noted in the article, USP standards regularly filter down into regulations that might be federal or state, and/or incorporated by accrediting organizations. As such, it behooves any compounding pharmacy, to get into compliance before an inspection or a reaccreditation. Take special note of the substantive changes to Chapters 787 and 800.
Visit the USP website to learn more.
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USP Countdown: Where Are You With Less Than Five Months to Go?
JUNE 21, 2023
With less than five months left before the revised USP compounding-related chapters <795>, <797>, <800> and <825> become compendially applicable on Nov. 1, 2023, experts at the ASHP 2023 Summer Meetings and Exhibition urged hospital pharmacy leaders to complete a gap analysis if they have not done so already, be aware of additional and possibly more stringent requirements that their states may have in place over and above the USP minimum standards, and use the available survey tool from The Joint Commission (if they’re accredited by the organization).
