Regulated by a diverse range of state boards with their own expectations, compounding pharmacies in the United States have historically faced challenges due to the absence of a nationally accepted approach to compliance. The introduction of Sections 503A and 503B to the Food, Drug, and Cosmetic (FD&C) Act in 2013 set regulatory expectations for compounding pharmacies and Current Good Manufacturing Practice (CGMP) outsourcing facilities. In addition, the FDA issued a draft Guidance for Industry in 2020 on the agency’s current thinking on regulatory expectations for 503B outsourcing facilities.
In response to industry demands and regulatory complexities, ISPE developed this comprehensive guide to serve as an invaluable resource for 503B outsourcing facilities, aiding them in understanding the regulatory requirements outlined in the FD&C Act Section 503B. The Guide 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, from the importance of CGMPs to establishing a quality system (including qualifying suppliers and vendors), receipt of raw materials/active ingredients, and 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, and presents industry best practices for aseptic manufacturing, emphasizing personnel training and qualification.
The 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 along with stability best practices. A dedicated chapter on preparing for regulatory inspections provides facilities with a valuable resource for this key aspect in ensuring compliance.
Recognizing the pressing need for best practice sharing, training, and guidance for creative problem solving in compounding pharmacies, ISPE launched a new ISPE Community of Practice (CoP) on Pharmaceutical Compounding. This CoP is designed to serve as a dynamic and collaborative community for ISPE members to exchange insights, share best practices, and engage in discussions related to pharmaceutical compounding through the ISPE Engage online platform.
The CoP seeks to foster innovation to improve the practice of pharmaceutical compounding, and to disseminate ideas, knowledge, and best practices through generation of ISPE content, including guidance documents, Pharmaceutical Engineering® Magazine articles, webinars, blog posts, conference presentations, and training materials. The new CoP will provide a venue for industry and regulatory informal interactions to drive practical and effective design and operational practices, while addressing regulatory expectations and providing solid scientific justification for practices accepted by industry and regulators alike.
Individuals interested in being considered for participation on the newly forming Steering Committee to lead the ISPE CoP on Pharmaceutical Compounding are urged to email ISPE at email@example.com.
ISPE is proud to provide critical guidance to the pharmaceutical compounding industry with the release of the "ISPE Guide: 503B Compounding – Regulatory Basis and Industry Good Practices for Outsourcing Facilities" and the launch of the ISPE CoP on Pharmaceutical Compounding. These comprehensive resources signal a transformative step towards fostering collaboration, innovation, and excellence among professionals in this vital sector, and underscore our commitment to advancing knowledge and enhancing compliance within the industry. We believe these initiatives will play a pivotal role in shaping the future of pharmaceutical compounding, ultimately benefitting patients and communities worldwide.