Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency

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Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency

Today, the FDA issued a guidance for immediate implementation setting forth a temporary policy for outsourcing facilities to compound certain human drugs for hospitalized patients during the COVID 19 public health emergency. This guidance is being issued to help ensure treatment options are available for hospitalized patients with COVID-19 when hospitals experience difficulties accessing certain FDA-approved drugs. For certain drugs, FDA does not intend to take action, against outsourcing facilities for compounding a drug that is essentially a copy of an approved drug, using a bulk drug substance that is not on FDA’s 503B bulks list, or not meeting current good manufacturing practice requirements with regard to product stability testing and the establishment of an expiration date when certain circumstances are present. View Guidance

For more information, please visit FDA's Human Drug Compounding web site.