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Section 582(g)(1) of the FD&C Act sets forth the requirements for enhanced drug distribution security as of November 27, 2023, including (as described in that provision and generally summarized here): The exchange of transaction information and transaction statements in a secure, interoperable, electronic manner.

The start date of the package-level electronic tracking system will shift from November 27, 2023 to November 27, 2024.

The FDA's Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data reflects the Agency's commitment to encourage the inclusion and greater representation of a diverse patient population in biomedical research leading to the development of medical products.

DSCSA 2023 Requirements The traceability requirements in effect from 2015 to 2023 generally require products to be traceable at the lot level. A second phase of requirements will go into effect November 27, 2023 to allow the interoperable, electronic tracing of products at the package level.

Again, under section 582 of the FD&C Act, trading partners must have systems in place that enable them, upon determining that a product in their possession or control is suspect or upon receiving a request for verification from the FDA that has made a determination that a product within the possession or control of the ...

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Sections 583(c) and 584(d)(2)(A) of the FD&C Act provide, respectively, that FDA may approve “third-party accreditation” or inspection services or programs to conduct inspections of facilities used by wholesale distributors seeking licensure and to review the qualifications of 3PLs for licensure.

The FDCA authorizes the FDA with the following tasks, among many others: Mandate drug manufacturers to submit evidence of new drugs' safety and effectiveness before marketing and distribution to the general public. Issue and enforce quality standards for food, drugs, medical devices, and cosmetics.