Medication Compounding Certification | Joint Commission
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Wednesday 3:17 CST, February 21, 2018

State Pharmacy Boards Stakeholders

Quality compounding of medicine is foundational to patient safety and may serve to reduce the incidence of adverse healthcare associated conditions such as infections and medication errors. USP Compounding Standards <797> and <795> aim to assist hospitals in improving the quality of the healthcare they deliver. As such, it is part of USP’s mission to support the advancement of healthcare quality and safety. USP is proud to work with The Joint Commission on this important endeavor and would also like to commend institutions that demonstrate their commitment to quality through such certification processes.”

Jaap Venema, Ph.D., USP Chief Science Officer

Information on the Joint Commission’s Medication Compounding certification program for State Boards of Pharmacies:

A series of events related to medication compounding, have led many State legislatures and Boards of Pharmacy to enhance laws and regulations pertaining to the practice of compounding pharmaceuticals.  Several states have enacted legislation, and many more are in the process of revising their regulations, to mandate compliance with the United States Pharmacopeia (USP) chapter <795> for non-sterile compounding and chapter <797> for sterile compounding.  As states move forward with enforcing the new requirements, some have expressed concern over the availability of sufficient resources to validate compliance with the regulations.  Reliance on the Joint Commission’s Medication Compounding Certification program in lieu of conducting state inspections is an efficient means of ensuring pharmacies providing compounding pharmaceuticals are compliant with the expectations.

The events driving Boards of Pharmacy to modify their regulations governing the practice of compounding pharmaceuticals were the impetus for the Joint Commission developing the Medication Compounding certification program.  However, we also received considerable feedback from our accredited organizations, particularly hospital based pharmacies, indicating the need for a more focused and specialized evaluation of the facilities compounding practices to meet the expectations of state regulatory bodies.  To meet the needs of the state regulatory bodies, as well as our accredited customers, the Medication Compounding certification program was designed to:

  • Evaluate a pharmacies compliance with standards that were based off the sterile and non-sterile compounding requirements issued by the USP in its chapters <797> and <795>
  • Onsite review conducted at least once every two years
  • Reviews completed by pharmacist surveyors that have undergone specific training in evaluating USP compliance.

Experience with the Michigan Board of Pharmacy

Michigan law now requires pharmacies providing sterile compounding services to obtain accreditation as a means of validating compliance with USP <797>. The Michigan Board of Pharmacy formally approved the Joint Commission’s Medication Compounding certification program as an option for pharmacies in meeting the accreditation requirement of the law in August of 2016. The Joint Commission has conducted over 75 Medication Compounding reviews in the first half of 2017 in Michigan hospital pharmacies, allowing the facilities to meet the June 30, 2017 accreditation deadline put forth by the Board of Pharmacy. The Joint Commission stands ready to work with State Pharmacy Boards, Professional Associations and Pharmacies to facilitate a timely and thorough evaluation of a pharmacies compounding practices to demonstrate compliance with USP <797> and/or <795>. For more information on how your state can rely on the Joint Commission’s Compounding certification program, please contact Jennifer Hoppe.

About the Program

The Joint Commission’s Medication Compounding Certification is a voluntary certification program for compounding pharmacies seeking an independent evaluation and recognition of compliance with USP Chapters <797> and <795> (the evaluation will include <800> once they are implemented).

The program has been developed to recognize organizations that demonstrate excellence in medication compounding through a combination of standards compliance for both Joint Commission standards for medication compounding and the USP standards.

This program is open to all organizations performing medication compounding.