Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The comment period closed Sep 11, 2026.
The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the drug establishment registration and drug listing requirements with respect to establishments engaged in distributed manufacturing and foreign drug establishments. This action, if finalized, will provide a pathway for a distributed manufacturing establishment that manufactures drugs at multiple different physical lo
Summary from the Federal Register.
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Full history
- Jul 13, 2026
Rule published
Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
Health and Human Services Department
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From the Federal Register. This record was last updated Sep 24, 2026. About our data
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A rule from Health and Human Services Department. Agora lists the comment window as the Federal Register gives it.
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