On Nov. 1, the new U.S. Pharmacopoeia standards on sterile and nonsterile compounding will be implemented. Here's what leaders need to know about USP 795 and USP 797:
1. <795> Pharmaceutical compounding — nonsterile preparations: Beyond-use-dates (BUDs) will be altered for:
a. Nonpreserved aqueous dosage forms (water activity ≥ 0.60) = 14 days
b. Preserved aqueous dosage forms (water activity ≥ 0.60) = 35 days
c. Oral liquids (nonaqueous) (water activity < 0.60) = 90 days
d. Other nonaqueous dosage forms (water activity < 0.60) = 180 days
2. <797> Pharmaceutical compounding — sterile preparations: Categorizing compounded sterile preparations from microbial contamination risk will change from a scale of low- to high-risk levels to three categories while assigning BUDs of up to 180 days.
3. For the compounding of hazardous drugs, the new rules will require all solutions used inside ISO 5 cleanroom devices to be sterile, according to the American Society of Health-System Pharmacists.
4. Joint Commission surveyors will physically inspect ISO spaces to ensure they are properly caulked, HEPA filters and sensors are properly installed, and all required testing was performed.
5. Every six months, "facility factors, such as air exchange, high-efficiency particulate air filter integrity, and pressure differentials," will need to be certified as compliant, the ASHP said.
Amber Strader, compounding regulatory coordinator at Greensboro, N.C.-based Cone Health, told Becker's the technology Simplifi has helped her ensure USP compliance among the 10 pharmacy cleanrooms she oversees.
"We have implemented Simplifi 797 and — pun intended — it has simplified our life in maintaining compliance in our tasks and our competencies in our cleanrooms," said Ms. Strader, who was promoted to her role about a year ago. "It's very easy to find the documentation, run the analytics. The compliance goes further than just daily tasks and competencies but also incorporates new standards involving surface sampling and environmental monitoring, which is going to increase severely. It's helped us already implement that to where we're already ahead of the game."