Drug Shortages and Risk Management Plans

by | Aug 16, 2023 | Classification, Compliance, Enforcement Actions, FDA, Pharmaceuticals, Regulatory

Supply chain issues are occurring all around the country which includes drug shortages. Drug shortages are considered a public health threat as they can delay and deny critically needed care for patients1. The Food and Drug Administration (FDA) has pushed for fewer drug shortages and short lead times for the past decade.

The FDA is actively mitigating and preventing new drug shortages however the disturbances in the United States drug supply have only been worsened with a trend of pharmaceutical quality issues, weak global supply chain, increased consumer demands, and marketed withdrawal of drugs1. With the national drug shortages, the FDA has drafted new guidance for Risk Management Plans to Mitigate the Potential for Drug Shortages. This new guidance will assist manufacturers to develop, maintain, and implementrisk management plans to assist in the prevention of drug and biological product shortages2.

Risk Management Plans are the basis of identifying, prioritizing, and implementing strategies to mitigate potential risks or hazards that may lead to supply issues for the manufacturer in the industry. There are two main principles of the risk management plan that should be implemented as part of your QMS:

  • The assessment of the risk to quality should be based on scientific knowledge and linked to the protection of the patient/user
  • The level of effort, formality, and documentation of the quality risk management process should be commensurate with the level of risk2.

If your company needs assistance with the development of your risk management plan or any other aspects of your Quality Management System, EMMA International is here to help. Contact us by phone at 248-987-4497 or by email at info@emmainternational.com.

1FDA (May 2022) FDA Urges Drug Manufacturers to Develop Risk management Plans to Promote a Stronger Resilient Drug Supply Chain, retrieved on June 14, 2022, from https://www.fda.gov/news-events/press-announcements/fda-urges-drug-manufacturers-develop-risk-management-plans-promote-stronger-resilient-drug-supply?utm_medium=email&utm_source=govdelivery

2FDA (May 2022) Risk Management Plans to Mitigate the Potential for Drug Shortages, retrieved on Jun 14, 2022, from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/risk-management-plans-mitigate-potential-drug-shortages

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