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The Joint Commission Launches Medication Compounding Certification
Certification Addresses New Medication Compounding Laws and Regulations
(OAKBROOK TERRACE, Illinois – February 21, 2017) – Across the United States, patient safety and quality events related to medication compounding have led many state legislatures and boards of pharmacy to enhance and strengthen regulations. To support health care organizations in complying with these requirements, The Joint Commission has developed a new Medication Compounding Certification program.

The certification is open to all compounding pharmacies operating or shipping to states with regulations that require compliance with United States Pharmacopeial Convention (USP®) General Chapters 797 and/or 795. The USP develops and disseminates quality standards for medicines and other articles; Congress has consistently referenced USP standards in federal food and drug legislation.

Compounding pharmacies refer to any physical pharmacy that is licensed to mix or “compound” chemical ingredients into a finished medication. Medication compounding became a widespread patient safety and quality concern after a multistate meningitis outbreak from a contaminated compounded medication in 2012. The outbreak resulted in more than 750 cases and 60 deaths, according to the Centers for Disease Control and Prevention.

Since then, as state regulatory boards have begun to explore new compounding regulations, The Joint Commission identified need among compounding facilities for support in preparing for such regulations. 

“After assessing the need for a more focused and specialized evaluation of facilities’ sterile compounding practices, The Joint Commission recognized it was important to design a program that would help organizations reduce risk and harm,” said Robert Campbell, Pharm.D., surveyor, Hospital Accreditation Program, The Joint Commission. “Organizations that successfully achieve this certification have demonstrated compliance with nationally accepted standards of practice for sterile medication compounding.”

The certification program, awarded for a two-year period, was developed with extensive collaboration with the USP to help health care organizations ensure compliance with Joint Commission and USP standards, including those related to the process, testing and verification of compounded sterile and nonsterile preparations. In addition, the certification program helps organizations discover and address hidden gaps in related policies and procedures, focusing on:

  • People: training, competency, proper use of personal protective equipment and aseptic technique
  • Product: sterility of base products, expiration dates and labeling
  • Environment: airflow, buffer areas, guidelines for cleaning and documentation, and storage

Extensive research, literature review and stakeholder engagement also guided The Joint Commission’s development of the Medication Compounding Certification. This included Technical Advisory Panels, in-depth environmental assessments and strategic leadership meetings with industry experts within and outside The Joint Commission.

For more information, eligibility requirements and how to apply for Medication Compounding Certification, visit The Joint Commission website.  

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The Joint Commission
Founded in 1951, The Joint Commission seeks to continuously improve health care for the public, in collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel in providing safe and effective care of the highest quality and value. The Joint Commission accredits and certifies more than 21,000 health care organizations and programs in the United States. An independent, nonprofit organization, The Joint Commission is the nation’s oldest and largest standards-setting and accrediting body in health care. Learn more about The Joint Commission at www.jointcommission.org.


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The Joint Commission
 

 
   
About Medication Compounding Certification

National Conference of State Legislatures: State Regulation of Compounding Pharmacies

About The Joint Commission

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Elizabeth Eaken Zhani
Media Relations Manager
630-792-5914
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Katie Looze Bronk
Media Relations Specialist
630-792-5175
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