A Bitter Pill To Swallow? Changes to Sterile Compounding Pharmacies

May 23, 2017

 

minion maidThe California Board of Pharmacy (CBP) has changed the requirements for Sterile Compounding Pharmacies to capture and align with the changes that were a part of Senate Bill 294. These changes affect S1735 (Compounding in Licensed Pharmacies) and S1751 (Sterile Compounding) and they both became enforceable on January 1st of this year.

Additionally, changes by the US Pharmacopeia to Chapter 797 (Pharmaceutical Compounding-Sterile Preparations) and the addition of an entirely new chapter altogether (Chapter 800) having to do with the Handling of Hazardous Drugs in Healthcare Settings, are all co-factors influencing the current climate in healthcare as it relates to code required renovations.

 

The changes that are encompassed within these conditions will have some effect on existing architectural, interiors, electrical, and mechanical components to achieve compliance with the CBP requirements.

 

Because Sterile Compounding Pharmacies in Hospital facilities fall under the requirements for OSHPD-1, these improvements will have to go through the standard approval process and protocol for OSHPD projects. This includes the creation of Contract Documents involving drawings, material and installation specifications, then the submittal, review, and permit process, backchecks and resubmittals, along with all the Verified Reports and Testing, Inspection, and Observation criteria that are typically required at project completion.

This process will involve hiring an Architect of Record, Electrical Engineer of Record, Mechanical Engineer of Record, Inspector of Record and quite possibly a Structural Engineer of Record to be certain that the renovations are correctly implemented and approved by OSHPD.

 

For more information about these changes here is an informative video https://www.youtube.com/watch?v=Wv7YyeeUoVw&feature=youtu.be

or visit the California State Board of Pharmacy website

www.pharmacy.ca.gov

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