Federal Register #FDA-2025-N-6075

FDA Proposed Rule: Drug Establishment Registration and Listing for Distributed and Foreign Manufacturers

This opportunity involves a proposed regulatory change by the Food and Drug Administration (FDA) under the Department of Health and Human Services. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - No OEMs or commercial vendors are named, as this is a regulatory rulemaking, not a procurement for products or services. - Products/Services Requested: - No products, part numbers, or quantities are specified; this is not a purchase request. - Notable Requirements: - Establishes a pathway for distributed manufacturing establishments (operating at multiple physical locations) to register as a single entity, reducing regulatory burden. - Requires implementation of a unified pharmaceutical quality system (UPQS) for distributed manufacturing hubs and units. - Mandates preapproval inspections for each drug profile class manufactured by distributed manufacturing units. - Aligns registration and listing requirements for foreign drug establishments with statutory changes from the PREVENT Pandemics Act. - Clarifies applicability of registration and listing regulations for foreign drug manufacturers.

Description

The Food and Drug Administration (FDA) is proposing to amend the drug establishment registration and drug listing requirements concerning establishments engaged in distributed manufacturing and foreign drug establishments. The proposed rule aims to provide a pathway for distributed manufacturing establishments that operate at multiple physical locations to register as a single entity. It also seeks to align drug establishment registration and drug listing regulations for foreign establishments with statutory changes introduced by the PREVENT Pandemics Act. The rule is intended to decrease regulatory burden while ensuring FDA obtains necessary information to support public health responsibilities.

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