Health-Systems & the New CA Sterile Compounding Law

Health-systems practitioners in California have begun the application process for obtaining a license for sterile compounding (LSC) from the Board of Pharmacy. Before Jan 1, 2014, health-systems accredited by the Joint Commission or other agencies were exempt by the board from obtaining a separate license for sterile compounding. IV manipulations and other parenteral medications prepared in a clean room or even satellite hoods will now require a LSC from the board. Initial inspections by the board have revealed a few common missing requirements that health-systems pharmacies do not yet have in place. In this piece I will discuss the issue of Personnel Training & Documentation that health-systems pharmacies performing sterile compounding, or the preparation of any parenteral medication, must implement before the board will grant a LSC. 

The Who, What, and How of Personnel Training & Documentation 

Who: All personnel engaging in sterile compounding or aseptic manipulation of parenteral medication, including technicians, pharmacists, intern pharmacists and possibly other hospital personnel. 

What: All personnel must pass an initial competency process evaluation prior to preparing sterile medications for patients. The initial competency required is also known as a media fill test. The media fill test is performed by preparing a sterile medication as usual for a patient, but instead of a delivery solution, a microbial growth medium is used and the sample is incubated to test for microbial contamination. 

Although CA law does not specifically state that the testing of gloves is required, a performance evaluation is required as part of the quality assurance program. In this instance, it is highly recommended to follow the USP <797> guidelines for initial and periodic gloved finger tip sampling of all personnel to ensure gloving technique is sound and does not increase the chance of touch contamination. 

Another part of a compliant and effective personnel training program is the didactic review of the pharmacy's policies and procedures and all requirements for ensuring safe aseptic technique. To implement this system, a written quiz containing information on aseptic technique, beyond use dating, disinfecting, storage, labeling, equipment, and facility requirements should be administered to and passed by all personnel. Additionally, issuing a copy of the policies and procedures for sterile compounding and a signed acknowledgement of reading and understanding the material should be documented. 

If the pharmacy prepares hazardous, namely cytotoxic, drugs for patients in the hospital, additional detailed training and documentation is required. 

For many health-systems, the annual review of this material is required. For facilities performing high-risk compounds (compounds from one or more non-sterile ingredients), a semi-annual review is necessary among several other requirements. 

How: The pharmacy must document all training and retain the training files for at least 3 years. One way to keep track of these documents is to assign each employee an individual training file which can be accessed easily by both personnel and regulatory authorities. Included in this files should be the previously mentioned requirements, signed acknowledgement of having received certain information, and other documentation that may be specific to the scope of the pharmacy's sterile compounding. 

Other requirements health-systems must review to ensure compliance with are :

  • Facilities
  • Equipment 
  • Master Formula Records 
  • Labeling of Preparations
  • Beyond Use Dates 
  • Quality Assurance Program 

Because heath-systems greatly vary in terms of size, infrastructure, facilities, and scope of compounding, so will the requirements for each. The CA Board of Pharmacy has increased the number of inspectors in hopes of meeting the demand to inspect and grant licenses to California's numerous health-systems applying for a LSC. 

Designing and implementing new requirements and major changes into a health-systems pharmacy is no easy task. The first, most critical step is deciding how the health-system will address the new requirement by the board of pharmacy. Often times, charging internal personnel to handle these issues is time and resource consuming. For certain types of health-systems, this may be an acceptable choice, and for others, the misallocation of human capital can have negative consequences on quality of care, finances, and department harmony. 


Visit to discover if streamlining this licensure process is the right decision for your health-system or pharmacy practice.