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Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments Regulatory Impact Analysis (Proposed Rule)

This proposed rule, if finalized, would revise drug manufacturing establishment registration regulations to provide instructions specifically for registering distributed manufacturing establishments. Distributed manufacturing is a decentralized manufacturing strategy that uses advanced manufacturing technology. For the purpose of this proposed rule, a distributed manufacturing establishment (DME) uses a “hub-and-spoke” model that consists of DM units (i.e., DMUs or the “spokes”) that are equivalent in design and operation and manufacture the same drug(s) at multiple geographic locations under the oversight and control of a single quality unit that implements a unified pharmaceutical quality system (UPQS) with a management structure at the DM “hub.” If finalized, this proposed rule would also update the drug establishment registration and listing requirements for foreign establishments to align the regulations with the recent changes made by Congress to section 510 of the FD&C Act. 

We briefly describe the qualitative benefits to drug manufacturers and FDA from eliminating redundancy related to registering a network of DMUs. Unquantified benefits include greater visibility into the drug supply chain. We expect improved supply chain visibility to help support FDA’s efforts with respect to preventing and mitigating drug shortages. We quantify costs to drug manufacturers for reading and understanding the rule, and to FDA for updating structured product labeling (SPL) submission schema, tools, and internal databases. Using a pre-statute baseline, we also estimate costs to unregistered foreign firms required to register and list with FDA, as well as FDA labor costs to assist these foreign registrants; though changes to statute made by section 2511 of the PREVENT Pandemics Act introduced no new requirements on foreign establishments and only clarified existing requirements, we expect this clarification to increase compliance among covered foreign establishments. At a seven percent discount rate, estimated annualized net costs range from approximately $532,811 to $664,495, with a primary estimate of $583,958. At a three percent discount rate, estimated annualized net costs range from approximately $482,472 to $606,839, with a primary estimate of $533,771.

Regulatory Impact Analysis

Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments Regulatory Impact Analysis (Proposed Rule) -- PRIA (PDF 794 KB)

Federal Register: 91 FR 42888
Publication Date: 7/13/2026 
Docket: FDA-2025-N-6075

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