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# Drug Groups Seek Changes to FDA's Distributed Manufacturing Rule
- URL: https://www.fdaweb.com/drug-groups-seek-changes-to-fda-s-distributed-manufacturing-rule-d5161811/
- Published: 2026-09-21T16:00:00.000Z
- Updated: 2026-09-21T16:00:00.000Z
- Author: David McFarland
- Tags: Drugs, Legacy-ID-D5161811, #Import 2026-09-24 19:50

Three major pharmaceutical industry associations are urging FDA to revise its proposed distributed manufacturing rule to provide greater flexibility for existing multi-site manufacturing networks, clarify inspection and registration requirements, and avoid imposing additional regulatory burdens that could undermine drug supply-chain resilience.

In 9/21 comments to the agency, the Biotechnology Innovation Organization (BIO), the Association for Accessible Medicines (AAM), and the Pharmaceutical Research and Manufacturers of America (PhRMA) generally supported the agency's proposal to streamline registration for distributed manufacturing establishments but identified numerous areas requiring clarification before the rule is finalized. The proposed rule would establish a registration framework for distributed manufacturing establishments (DMEs), allowing multiple manufacturing units operating under a unified pharmaceutical quality system to be registered through a centralized hub. It also addresses registration and drug listing requirements for certain foreign establishments.

The three associations said the framework could reduce duplicative regulatory requirements and facilitate more flexible manufacturing arrangements, but cautioned that its eligibility criteria and implementation requirements could limit those benefits.

A central concern shared by the associations is FDA's proposed distinction between distributed manufacturing and traditional multi-site manufacturing. BIO and AAM said the proposal does not adequately explain whether companies operating multiple facilities under common ownership and centralized quality oversight would qualify for streamlined DME registration. Both organizations urged FDA to avoid creating regulatory distinctions that could discourage manufacturers from maintaining qualified backup facilities or geographically diversified supply networks.

AAM emphasized that manufacturing redundancy is particularly important for mature generic drugs, which may have limited alternative manufacturing capacity. BIO recommended extending comparable regulatory flexibility to affiliated manufacturing networks that demonstrate equivalent manufacturing processes and unified quality oversight.

PhRMA also called for broader eligibility, recommending that FDA allow distributed manufacturing arrangements involving contract manufacturing organizations and other third parties. The association further urged FDA to clarify that manufacturing units producing different strengths, dosage forms or formulations of a drug could qualify for the same DME when they share an active ingredient, manufacturing process and quality system.

The associations also raised concerns about how FDA inspections and compliance classifications would apply to manufacturing networks operating under a single DME registration. AAM warned that an Official Action Indicated (OAI) inspection classification arising from a deficiency at one manufacturing unit could potentially affect applications involving other geographically separate facilities operating under the same registration. It asked FDA to clarify that an OAI classification or warning letter involving one unit would not automatically extend to other units or the central manufacturing hub.

PhRMA similarly recommended that localized inspection deficiencies be addressed without automatically affecting the registration, application status or compliance standing of the entire manufacturing network. PhRMA also questioned the proposal's preapproval inspection requirements, recommending a risk-based approach under which FDA could inspect a central hub or selected manufacturing units rather than requiring inspection of every unit in all circumstances.

All three associations requested additional technical guidance on implementing the new registration framework, including how FDA's electronic systems would accommodate multiple manufacturing locations, mobile units and existing facility identifiers. BIO and AAM urged FDA to preserve existing Facility Establishment Identifier (FEI) and DUNS numbers to avoid disrupting approved applications, drug listings and inspection records. PhRMA also recommended changes to the proposed relocation notification requirements for mobile manufacturing units, arguing that the 30-day domestic and 120-day foreign notification periods could limit their rapid deployment during emergencies.

[Comments by PhRMA](https://downloads.regulations.gov/FDA-2025-N-6075-0054/attachment%5F1.pdf?ref=fdaweb.com)   
[Comments by AAM](https://downloads.regulations.gov/FDA-2025-N-6075-0051/attachment%5F1.pdf?ref=fdaweb.com)   
[Comments by BIO](https://downloads.regulations.gov/FDA-2025-N-6075-0052/attachment%5F2.pdf?ref=fdaweb.com)