In spring 2018, the United States Pharmacopeia (USP) announced plans to revise general chapters <795> and <797>, which set standards for compounding nonsterile and sterile preparations. The goal was to better align these 2 chapters with USP <800> (“Hazardous Drugs — Handling in Healthc...
Simplifi 797 is a customizable, expert-developed solution that takes the effort out of Chapters USP 795, USP 797, and USP 800 compliance Optimize operations and pass inspections with the only automated, closed-loop compliance support. Improperly compounded medications can have tragic effects. USP ...
IJPC GAP Analysis Surveys IJPC's USP compliance documents have moved to our sister site CompoundingToday.com. For a free download of all the USP compliance documents please see: http://compoundingtoday.com/Compliance/USPGap.cfm.
*Select USP <800>, USP <797>, and USP <795> compliance transition assistance and regulatory support services are available at no cost to our loyal customers. A full range of comprehensive regulatory / compliance support is available at discounted rates through Letco’s Regulatory Solutions Program...
Enhance your compounding practice with our Sleeve Kit – a premium,flexible PVC sleevethat seamlessly combinesdurability, comfort, and safety. Compliant withUSP <797> or <800>guidelines ensuresuncompromised protectionwhile featuring a lightweight, breathable design that can befully customizedto meet your...
USP 800 合规性指南：评估风险说明书
The enclosures outlined below allow, with additional measures, a facility to become compliant to USP 800 requirements. These products are considered to be either Class I, Class II BSCs and LAFW's for use in compliance to USP 800 or relevant sections of USP 795 and USP 797. ...
The enclosures outlined below allow, with additional measures, a facility to become compliant to USP 800 requirements. These products are considered to be either Class I and LAFW's for use in compliance to USP 800 as well as relevant sections of USP 795 and USP 797. ...
USP recently announced that it will delay the implementation of chapters on pharmaceutical compounding for nonsterile preparations (<795>) and sterile preparations (<797>), pending appeals of some sections in those chapters. As initially planned, USP <800> was deemed official as of December 1, ...
Prior toUSP <800>, the main guidance related to the handling of HDs was USP <797>. This regulation described the proper guidelines for sterile compounding of both hazardous and nonhazardous drugs, with a main goal of preventing harm to patients that could result from microbial or other contami...