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Understanding FDA's Guidance on Reporting Drug Manufacturing and Distribution under the CARES Act

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Ethan Sulliva
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Understanding FDA's Guidance on Reporting Drug Manufacturing and Distribution under the CARES Act

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In an ongoing response to the COVID-19 pandemic, the Food and Drug Administration (FDA) has issued a guidance document to assist drug establishments. This guidance aims to facilitate the process of submitting reports on the quantity of each listed drug that is manufactured, prepared, propagated, compounded, or processed for commercial distribution. This requirement is set forth by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The guidance also provides details on how to submit comments and the address for mailing written comments.

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An Overview of the CARES Act Compliance for Drug Establishments

The FDA has released specific guidance on reporting drug manufacturing and distribution under the CARES Act. Drug manufacturers and distributors are required to report any disruptions in manufacturing or distribution due to the COVID-19 pandemic. The guidance outlines the specific information that should be included in these reports, such as the impact on the supply chain and potential shortages. This initiative aims to ensure the availability and continuous supply of essential medications during the pandemic.

Regulations and Guidelines for Medications Used in Opioid Use Disorders

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Within the same context, the Substance Abuse and Mental Health Services Administration's (SAMHSA) Division of Pharmacologic Therapies has provided information about the regulations and guidelines for medications used in the treatment of opioid use disorder. These include drugs like methadone and buprenorphine. The guidance provided also includes information on various aspects such as methadone take-home flexibilities, split dosing, holiday guidance, and mobile components.

FDA's Quality Management System Regulation for Medical Devices

In addition to drug regulations, the FDA has issued the Quality Management System Regulation (QMSR) Final Rule, which amends the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation 21 CFR Part 820. This rule incorporates the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO). The rule is effective from February 2, 2026, and until then, manufacturers are required to comply with the QS regulation.

The FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with include Establishment Registration, Medical Device Listing, Premarket Notification, Premarket Approval, Investigational Device Exemption, Quality System Regulation, Labeling, and Medical Device Reporting.

The issuing of these guidance documents by the FDA and other authorities ensures that manufacturers and distributors of drugs and medical devices are better equipped to navigate these challenging times. It is crucial for these establishments to understand and adhere to these guidelines to ensure the safety and well-being of patients nationwide.

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