Gettng Ahead of the Regulatory Curve for Sterile Compounded Drugs

Last spring, the United States Pharmacopeia (USP) announced plans to revise General Chapter (GC) which sets standards for compounding nonsterile drugs, and , which addresses pharmaceutical compounding for sterile preparations. The overarching goal was to better align these two chapters with USP GC (“Hazardous Drugs – Handling in Healthcare Settings”), which was published in 2016 and is expected to become official 1 December 2019.

INDUSTRY NEWS

Challenges and Innovations in the Manufacture of Hazardous Drugs
Pharmacy Times

USP General Chapter sets forth guidelines for the handling of hazardous drugs in the health care setting with the goal of promoting safety for patients and health care workers.

USP 800 New Release Date and Important Facts
Blue Thunder Technologies

Do you work in healthcare or occupational safety and health? If so, you should absolutely know what USP 800 is and be aware of the new proposed release date. Knowing the ins-and-outs of how it works and why it matters is essential to protecting healthcare employee’s standards and managing healthcare quality standards.

USP Ushers in Sweeping Changes to Rules for Hospital and Retail Pharmacies
Pharmacy Times

In spring 2018, the United States Pharmacopeia (USP) announced plans to revise general chapters and , which set standards for compounding nonsterile and sterile preparations. The goal was to better align these 2 chapters with USP (“Hazardous Drugs – Handling in Healthcare Settings”), which was published in 2016 and goes into effect December 1, 2019.

ADDITIONAL UPDATES

Nursing Perspective to USP
Aseptic Enclosures

Developing standard operating procedures (SOPs) and ensuring ongoing adherence is integral to a successful hazardous drug (HD) safety program. Furthermore, it is required by USP , as Section 8 states that organizations must develop SOPs to cover all aspects of HD handling.

Trends in USP Compliance
Aseptic Enclosures

With less than a year to go until USP becomes enforceable, a significant effort is required for many facilities to achieve compliance with this chapter. For many attaining full compliance will require an investment in facility upgrades, purchases of new PECs, and a renewed focus on staff training.

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