Drug Shortage

Drug shortages demand attention and collaboration from regulators, industry, distributors and patient groups. This revision aligns the text of TR-68 from 2014 with the current regulatory environment and terminologies used for drug shortages.

PDA’s Contributions

Technical Report No. TR 68 (Revised 2024): Risk-Based Approach for Prevention and Management of Drug Shortages

TR-68 was originally developed as part of the inter-association collaborative response to the European Medicines Agency’s (EMA) initiative on medicinal product shortages caused by manufacturing, quality, and/or good manufacturing practice (GMP) issues. The risk-based approach and concepts in the original technical report are broadly recognized and remain unchanged.

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Drug Shortage Triage Model


Drug Shortage Risk Register - Appendix 1


Prevention and Response Plan - Appendix 2


Additional Resources

Scheduled Conferences and Training Opportunities

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