CHA News Article

CHA Posts Guidance, Tools for New Sterile Compounding Regulations
Webinar scheduled for June 28

In response to the 2012 New England Compounding Center tragedy — where contaminated injections led to 64 deaths and hundreds of illnesses nationwide — federal and state laws have been reexamined to provide increased oversight and better safeguards for compounded pharmaceuticals. To meet the new federal and state requirements, CHA urges hospital leaders and pharmacists in charge (PICs) to review the new regulations immediately, perform a gap analysis and develop a plan to meet federal and state requirements.

Details about the changes to United States Pharmacopeia (USP) Convention standards and Board of Pharmacy (BOP) regulations follow. In addition, CHA and the California Society of Health-System Pharmacists  have prepared an assessment tool to help hospitals assess their compliance; FAQs about the new regulations; and a set of grids describing the specific Board of Pharmacy and USP requirements and timelines – all available on the Sterile Compounding web page.

CHA’s Medication Safety Committee has advocated for state regulations that closely match USP standards and protect public safety, as well as leverage patient care delivery needs and the diverse hospital resources across the state. On June 28 from 10 a.m. – noon, CHA will offer a Sterile Compounding Webinar to review regulations, as well as the BOP’s waiver process.

Changes to Standards and Regulations
There are three key changes for California hospitals:

  1. New state regulations: The California Board of Pharmacy has developed new regulations for licensed pharmacies where sterile compounding occurs, which will go into effect Jan. 1, 2017.
  2. USP 800, finalized this year: The national professional standards that guide compounding practices and compounding administration of drugs are also being revised. The USP 800 was finalized in February 2016 and focuses entirely on employee safety when handling hazardous drugs; facilities will have two years to comply (July 2018). There is no waiver or mechanism to delay compliance with USP 800.
  3. USP 797, undergoing revisions: USP 797 is due to be finalized in January 2018, when the California Department of Public Health will use it for survey purposes.

What Hospitals Need to Know
Both the Board of Pharmacy’s updated regulations and the USP standards pertain to sterile compounding of hazardous and non-hazardous drugs. The most important information for hospitals is:

  • Changes throughout the regulations and standards apply to facility configuration, frequency of cleaning, testing and personnel training, and may require significant adaptation.
  • The most imminent challenge is for hospitals that conduct hazardous compounding. The state regulations will require a separate negative pressure room for hazardous sterile compounding, along with specific ventilation and air exchange requirements.
  • The Board of Pharmacy may offer a temporary compliance waiver if a facility’s physical construction or alteration to a facility or physical environment is necessary to meet the regulations.

After conducting an assessment, if a hospital needs to apply for a waiver, it should begin formulating a plan immediately. The waiver format will be available in June, and a waiver request must be submitted and approved by the Board of Pharmacy before Jan. 1, 2017. Facilities that are unable to secure a waiver should develop an alternate plan to procure prepared hazardous drugs, if needed.