The U.S. Food and Drug Administration (FDA) has issued a proposed rule that, if finalized, would allow manufacturers to use a “hub-and-spoke” model to register ​as a single facility — with multiple sites ​producing the same drug under a single quality management ⁠system, while enabling centralized oversight of production across different locations.

Under current ​regulations, each manufacturing unit in such a network must register separately ​with the FDA, “creating unnecessary administrative burdens.” The agency said its proposed rule would allow such manufacturing establishments to register as a single establishment, while enabling ​units to be added, relocated, or removed through a streamlined ​update process that ultimately will reduce registration costs for distributed manufacturing companies.

The distributed manufacturing (DM) model is defined by the FDA as a decentralized production strategy where a core manufacturing platform — consisting of raw materials, software, and equipment — is deployed across multiple manufacturing units across various locations.

“The FDA is proposing changes to our establishment registration regulations that would reflect how distributed manufacturing actually works — as one single establishment,” Michael Davis, acting director of FDA’s Center for Drug Evaluation and Research, said in a statement. “The proposed changes would make it easier for innovative manufacturers to operate efficiently, and give the FDA a clearer, more accurate picture of how and where drugs are being made.”

Following UK lead, cell therapies

Ori Biotech CEO Jason Foster, in a written statement to Pharma Manufacturing, said that the FDA is proposing a hub-and-spoke pathway for making a medicine at multiple physical sites under one central control similar to the Point-of-Care (POC) and Modular Manufacture (MM) framework from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). However, he noted that the agencies are at different stages as the UK rule is law and the FDA rule is a proposal open for comment.

“If enacted into law in the U.S., this should help open up access for patients to autologous cell therapies by enabling both manufacturing and treatment delivery to happen closer to the patient,” Foster said. “To do this right (i.e., in keeping with GMP), we would need mass adoption and roll out of automated manufacturing technologies (like Ori Biotech’s IRO) at the spoke manufacturing sites and a digital backbone connecting the hub and the spokes together.”

Ori Biotech’s IRO system, which last year received the FDA’s Advanced Manufacturing Technology (AMT) designation, automates, digitizes, and standardizes labor-intensive steps of cell therapy manufacturing in a fully closed system. According to Ori Biotech, the platform reduces costs, increases throughput, lowers batch failure rates, and enables scalability from research through GMP manufacturing.

Foreign manufacturers, supply chain

The FDA’s proposed rule also seeks to increase visibility of foreign drug supply sources by clarifying registration requirements for certain foreign establishments that manufacture drugs — including active pharmaceutical ingredients (APIs) — that indirectly enter the U.S. drug supply.

The agency said some foreign establishments currently manufacture drugs — including components such as APIs — only for distribution to other foreign establishments and may not be registered with the FDA, limiting its visibility of upstream supply chains.

“When an active ingredient in a medicine reaches an American patient, the FDA should be able to trace exactly where it came from,” Davis said. “Closing this registration gap for foreign establishments is a concrete step toward increasing the supply chain transparency that patients deserve.”

Last month, US Pharmacopeia (USP) released its annual drug shortages report and warned that U.S. reliance on single-country sourcing of key starting materials (KSMs) and APIs has left the upstream supply chain susceptible to disruption.

“For drugs in shortage, this upstream concentration can present a significant and often hidden vulnerability,” the report states. “Among the 75 drug shortages, 33 rely on at least one KSM produced exclusively in a single country. Six drugs in shortage depend entirely on KSMs from one country: four injectable products sourced solely from China and two oral solids from India.”

The U.S. supply chain for KSMs, the building blocks needed to manufacture APIs, is at risk due to America’s reliance on countries such as China and India for these critical chemicals, according to a separate 2025 report from USP.

“KSMs are the foundational chemicals necessary to commercially synthesize APIs,” according to USP. “Understanding trends like where KSMs are made, and where they are solely sourced from a single jurisdiction, can help decision-makers take action to address vulnerabilities in our supply chain.”

While there has historically been little insight into the upstream supply chain for medicines, USP claimed last year that it identified all KSMs likely used in the commercial production of all U.S.-approved APIs.