United States Pharmacopeia (USP) Compliance Consulting Services

Compounding practices must adhere to applicable USP General Chapters <795> for Non-Sterile Compounding, <797> for Sterile Aseptic Compounding, and <800> for Hazardous Drug Handling and Storage (effective Dec. 2019). Gates Healthcare Associates, Inc. guides its clients to understanding the importance of the quality and saftey standards as well as achieving compliance within their specific practice.

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Detailed Services

On-Site Compliance Assessments for USP <795>, <797>, and <800>

Lab Evaluation ⦿ Staff Competency ⦿ Policy & Procedure Review ⦿ Testing and Documentation Requirements ⦿ Quality Assurance and Performance Improvement ⦿ Storage and Handling

Off-Site USP Standards Educational Consulting

Understanding the importance of achieving compliance ⦿ Best Practice Guidance ⦿

Compounding Lab Design

Review Current and Proposed Lab Renderings ⦿ Construct Preliminary (non-architectural) Lab Design Drafts ⦿ Equipment Recommendations ⦿ Air Filtration System and HVAC Guidance
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