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Sterile Compounding: Issues and Resources

Including resources related to USP <797>

(August 17, 2006)

This NHIA webpage is designed to serve as an information clearinghouse for all developments related to the compounding of sterile preparations by infusion pharmacies. Information is organized into the following sections:

Background
Pharmacists have a crucial role in providing extemporaneously compounded sterile preparations (CSP's) to patients and for ensuring the sterility, safety, and efficacy of these preparations. In recent years, there have been isolated published reports of patient injury and death related to improperly compounded CSP's. These reports have prompted state, federal, and professional organizations to examine the adequacy of the current framework of standards pertaining to CSP's.

Over the past decade, infusion pharmacies have used a wide range of resources to guide the preparation of CSP's, including professional practice guidelines published by the American Society of Health-System Pharmacists (ASHP Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products) and the United States Pharmacopeia (USP<1206>, "Sterile Drug Products for Home Use,"); national accreditation standards of the Joint Commission on Accreditation of Healthcare Organizations, the Accreditation Commission for Healthcare, and the Community Health Accreditation Program; and, where applicable, state laws governing pharmacy practice.

Because of an increasing focus on medication safety, especially in the case of sterile preparations, an increasing number of state boards of pharmacy have adopted specific standards and licensure requirements for pharmacies that compound sterile preparations. The National Association of Boards of Pharmacy Model Act, designed to guide the development of state board of pharmacy laws and regulation with public interest as the central precept, promotes the inclusion of Model Rules for Sterile Pharmaceuticals in state pharmacy practice Act. Visit the NABP website to download these model rules; click on "pharmacy law" and then "publications" to access the free download.

Simultaneously, efforts are occurring on a federal level to strengthen the regulatory infrastructure related to the compounding of sterile preparations, including but not limited to parenteral (IV and other non-oral) preparations.

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United States Pharmacopeia (USP) Chapter <797> Compounding Sterile Preparations

Educational Resources on USP Chapter <797> Compliance

Educational Resources on Sterile Compounding

  • Sterile Product Preparation  
    NHIA Home Infusion Pharmacy Certificate Program. Module 6
    This module offers an overview of standards of practice related to sterile products, pharmacy design, biological safety cabinets, overview of compounding equipment and supplies. It also reviews aseptic technique and special considerations for use of sterile products in the home.
  • Sterile Product Preparation: A Multimedia Learning Tool (10 users)
    Sterile Product Preparation: A Multimedia Learning Tool helps you practice essential techniques by giving you unmatched, simulated experience of the workplace. Sterile Product Preparation is computer-based, interactive learning program that provides a thorough way to train pharmacists, technicians, and other students in this vital field. The software includes virtual preparation and clean rooms, unique user IDs, self-assessment exams, a mouse-over glossary, photos and video clips. This comprehensive network-based program comes with 10 "seats"; additional seats can be purchased in groups of five.
  • Compounding Sterile Preparations, 2nd Edition
    Formerly Principles of Sterile Product Preparation, Compounding Sterile Preparations 2nd Edition contains a thorough discussion of the compounding process, including facilities and equipment, garb, aseptic technique, and batch production; detailed coverage of the dispensing process, including expiration dating, labeling, storing, and handling of products; and seven key appendices listing professional standards established by the FDA, National Association of Boards of Pharmacy, and ASHP.

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Sterile Compounding in the News

State Boards of Pharmacy
All home infusion pharmacies must be licensed under the appropriate licensure category by the applicable state board of pharmacy. While state approaches to home infusion licensure, the trend in recent years has been toward the development of specific licensure categories for these pharmacies, in recognition of the facility, personnel, and quality assurance requirements of infusion pharmacies far above and beyond those of retail pharmacies that do not compound sterile parenteral products.
As of 2003, some 33 states had specific licensure requirements for home infusion pharmacies, often detailing requirements similar to those found in USP <797>. Several others instead specify that pharmacies comply with USP standards, which would "by default" require compliance with USP <797>. These include:

  • Alabama
  • Arkansas
  • Delaware
  • Florida
  • Minnesota
  • Michigan
  • Nebraska
  • New Jersey
  • Oklahoma
  • District of Columbia

NHIA Online Resources on State Boards of Pharmacy Related to Sterile Compounding

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Accreditation Issues
Health care organizations accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) can expect to be surveyed for compliance with a new chapter of the United States Pharmacopeia (USP)-National Formulary (USP-NF), "USP Tests and Assays Chapter 797, Pharmaceutical Compounding, Sterile Preparations."

The April 2004 issue of the Joint Commission Perspectives noted that "USP-NF standards in the chapter on compounding sterile preparations contain requirements related to product standards and additional good pharmacy practices."

While USP-NF Chapter 797 is not the focus of surveyors during an on-site survey, noncompliance with the major requirements of the chapter that relate to Joint Commission standards will be scored at the appropriate element of performance effective immediately using the appropriate track record for compliance with the new requirements.

To comply, organizations should immediately evaluate their current practices in the light of the new chapter and make appropriate changes.

ACHC Announces Position on USP <797>
In September 2004, the Accreditation Commission for Health Care, Inc. (ACHC) announced its position statement on USP <797>. While agreeing with recommendations in USP <797>, ACHC recognized that the chapter is currently undergoing a review and revision process by USP. So as not to be in conflict with the final ruling, ACHC is adopting a "wait and see" posture before releasing a full set of standards.

To read the complete press release from ACHC, please click here.

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Pharmacy Compounding Accreditation Board

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Other Information
Do you know of other resources, information, news or documents that should be included on this page? Please send them to NHIA for consideration.

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  1. US Pharmacopeial Convention, Inc. United States Pharmacopeia XXVI/National Formulary 21. USP Chapter <797>, Pharmaceutical Compounding-Sterile Products, Rockville, MD: US Pharmacopeial Convention, Inc; 1999: 2130-2143