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For outsourcing facilities under section 503B, FDA does not intend to take action against compounders for violations of the FD&C Act arising from conditions that depend on tirzepatide injection products inclusion on FDAs drug shortage list until March 19, 2025. The FDA also stated that it may still take action regarding violations of any other statutory or regulatory requirements, such as to address findings that a product may be of substandard quality or otherwise unsafe. For more information please visit: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize | FDA

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2007 Sep;83(983):57582