New Guide for Compounding Pharmacies

A significant portion of this guide addresses all relevant United States Pharmacopeia (USP) chapters that relate to the operation of 503A pharmacies. The differences in USP General Chapter <795> Pharmaceutical Compounding - Nonsterile Preparations and USP General Chapter <797> Pharmaceutical Compounding - Sterile Preparations are discussed throughout this ISPE guide. This is to aid 503A compounders in understanding the requirements and accessing appropriate information.

Compounding requirements for 503A pharmacies focus on the quality management system (QMS) and its application throughout the compounding process, including materials, facilities and equipment, environmental controls, storage, shipping, and transport. Readers will find the information on personnel knowledge and training requirements valuable. To aid pharmacies in maintaining compliance with federal and state regulations, several lists of suggested standard operating procedures based on the type of compounding conducted are included.

A survey of compounding pharmacies and regulators conducted by ISPE in early 2022 identified the need for guidance regarding pharmaceutical compounding FDA regulations and recommendations and USP criteria. The ISPE Guide: 503A Compounding - Regulatory Basis and Industry Good Practices for Pharmacies and ISPE Guide: 503B Compounding - Regulatory Basis and Industry Good Practices for Outsourcing Facilities, which was published in August 2023, are the result of ISPE’s response to that survey.

The ISPE Guide: 503B Compounding – Regulatory Basis and Industry Good Practices for Outsourcing Facilities combines FDA regulations and recommendations with pharmaceutical industry standards, providing a go-to document for 503B facilities of all sizes. Various aspects of the compounding process are covered: the importance of current GMPs, establishing a quality system (including qualifying suppliers and vendors), receipt of raw materials/active ingredients, and the shipping of finished drug products.

The guide also provides recommendations for facility and equipment design, drawing from aseptic manufacturing practices and scaled to meet the needs of 503B facilities. In addition, it presents industry best practices for aseptic manufacturing, emphasizing personnel training and qualification.

Additionally, the ISPE 503B Guide addresses microbiological and analytical testing, including verifying the suitability of compendial methods and validating non-compendial methods. It covers beyond-use dating, offering essential insights into limited stability testing, and stability best practices. A dedicated chapter on preparing for regulatory inspections provides facilities with a valuable resource.

In 2023, ISPE also established the Pharmaceutical Compounding Community of Practice (CoP), which seeks to foster innovation to improve the practice of pharmaceutical compounding, and to disseminate ideas, knowledge, and best practices. This is done through the generation of ISPE content, including guidance documents, Pharmaceutical Engineering® magazine articles, webinars, blog posts, conference presentations, and training materials.

The new CoP provides a venue for industry and regulatory informal interactions to drive practical and effective design and operational practices. It also addresses regulatory expectations and provides solid scientific justification for practices accepted by industry and regulators alike.

ISPE members interested in being considered to participate on the recently established Steering Committee leading the ISPE Pharmaceutical Compounding CoP are urged to email ISPE at communities@ispe.org

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