FDA issued a proposed rule titled “Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments” to modernize drug manufacturer listing requirements for certain entities. The proposed rule would permit a hub-and-spoke model single listing to identify multiple manufacturing sites engaged in a distributed manufacturing model. Now do not get too excited, the proposed rule is limited in that the spokes (units of the hub) must be under the same legal entity and the same overall quality unit organization.

The proposed rule states that ‘this action, if finalized, will provide a pathway for a distributed manufacturing establishment that manufactures drugs at multiple different physical locations to register as a single drug manufacturing establishment and align drug establishment registration and drug listing regulations applicable to foreign drug establishments with statutory changes made by the Preparing for and Responding to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act)’.

The FDA described the purposes of the proposed rule as to:

  • Provide revisions to the drug establishment registration regulations to accommodate distributed manufacturing (DM) by providing drug manufacturers that engage in DM with flexibility in registration requirements.
  • Propose updates to the drug establishment registration and drug listing regulations to incorporate clarifying changes to the statute made by section 2511 of the PREVENT Pandemics Act.

The proposed rule goes on to state that “DM is a decentralized manufacturing strategy that uses advanced manufacturing technology. Under our proposal, a distributed manufacturing establishment (DME) uses a hub-and-spoke model in which the physical manufacturing activities are conducted at DM units (DMUs) that are located at one or more geographic locations (“spokes”) under the oversight and control of a single quality unit, which has a management structure located at the DM “hub” and has implemented a unified pharmaceutical quality system (UPQS). The DMUs are equivalent in design and operation, manufacture the same drug(s), and can be added, removed, or relocated as needed to meet demand. In contrast, an establishment engaged in traditional manufacturing resides in one general physical location, and manufacturing is overseen by the manufacturer’s quality unit located in the same general physical location”.

The current registration requirements require each spoke of the DM hub to be separately registered and listed even though they operate as a single organization. If finalized, the rule would permit a single registration that identifies each of the “spokes” in the DM.

This rule does not apply to the use of traditional manufacturing that uses various contract manufacturers or other entities not under single control that support traditional drug manufacturing. Therefore, the hub-and-spoke model registration process would be limited to DM organizations

“Additionally, the Agency is proposing to amend the drug establishment registration requirements to clarify that the drug establishment registration requirements apply to each foreign establishment that manufactures, repacks, relabels, or salvages a drug that is imported or offered for import into the United States regardless of whether such drug undergoes further manufacture, preparation, propagation, compounding, or processing at a separate foreign establishment prior to being imported or offered for import into the United States”.

The concept proposed rule is designed to make for more efficient and flexible drug establishment registration and listing and while the 62-page proposed rule is a bit complex, it proposes an interesting option for a limited number of organizations and clarifies the registration and listing requirements for foreign manufacturers. So, get out your reading or magnifying glasses and take some time to see what the FDA has in store for you if anything. Don’t forget to comment on the proposed rule within 60 days from today!