nhia logo

Quick Links
Search NHIA.org

Sterile Compounding Resource Center

Welcome to NHIA's clearinghouse for information related to the compounding of sterile products.

The preparation of compounded sterile products (CSPs) in compliance with federal, state, and industry standards is a core function of home infusion pharmacy practice. Patients rely on the expertise of home infusion providers to ensure medications are prepared in a sterile, accurate, and safe manner. 

Home infusion providers must be informed of changing standards and regulations related to the professional practice of sterile compounding in order to remain in good standing with regulating bodies, and to ensure operating procedures are adequate to protect patients and employees. 

NHIA strives to ensure all stakeholders are informed of the latest trends in sterile compounding regulatory and standard setting activities, and regularly posts updated information on this site.

 

Oversight of Sterile Compounding

Oversight for sterile compounding practice falls primarily to the states and is typically governed by the individual state's board of pharmacy, however the Food and Drug Administration (FDA) also maintains authority to inspect pharmacies for insanitary conditions. In some states, the Board of Medicine (or similar entity) regulates sterile compounding that occurs in physician offices. Most pharmacies maintain active accreditation from an agency that performs rigorous inspections for compliance with state laws and internal policies. Majority of state laws and accreditation standards are based on the principles outlined in the U.S. Pharmacopeial Chapter <797> Pharmaceutical Compounding – Sterile Preparations.

 

USP Releases Final Revisions to Chapter <797>

On June 1, 2019, the USP released the long-awaited final revisions to General Chapters <797> Pharmaceutical Compounding - Sterile Preparations, and <795> Pharmaceutical Compounding - Nonsterile Preparations.

USP also released a newly developed Chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging. The USP Compounding Expert Committee reviewed over 8,000 comments during the revision process, which took place over a multi-year timeframe and included two draft revisions to solicit input from a wide range of stakeholders. All of these revisions, plus <800> Hazardous Drugs – Handling in Healthcare Settings, will have an enforcement date of December 1, 2019.

For more information please click on this link: USP website. NHIA members are encouraged to download revised chapters and view Talk Infusion Webinar, noted in Additional Resources.

 

Additional Resources:

 

News:

  • NC Board of Pharmacy takes position on USP <800>:
    Read More
    Read The Statement
    (9/29/17)
  • PTCB has made CPhT recertification easier and faster. Pharmacy Technicians must have an e-profile with NABP setup before their next recertification deadline. However, ALL CPhTs are required to have an e-profile setup no later than October 2019.
    Please click on link for details
  • PTCB developing Advanced CPhT credential. (CPhT-Adv).
    Please click link for details
  • PTCB Certification Eligibility Requirements to change January 1, 2020.
    Please click link for details
  • Board of Pharmacy Specialties (BPS) to hold its first exam for the Certified Sterile Compounding Pharmacist. Application deadline is August 1, 2019. Testing window will be open between September 20, 2019 to October 13, 2019.
    Please Click here for details
  • NIOSH is anticipating a December 2019 release of an updated List of Hazardous Drugs in Healthcare Settings.
    Learn More

Not an NHIA member? Learn about the many benefits membership in NHIA offers your company.