FOOD AND DRUG ADMINISTRATION ISSUES PROPOSED RULE: DRUG ESTABLISHMENT REGISTRATION AND DRUG LISTING REQUIREMENTS FOR ESTABLISHMENTS ENGAGED IN DISTRIBUTED MANUFACTURING AND CERTAIN FOREIGN ESTABLISHMENTS

WASHINGTON, July 13 -- Food and Drug Administration has issued a proposed rule called: Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments.

The proposed rule was published in the Federal Register on July 13 by Robert F. Kennedy, Secretary, Department of Health and Human Services.

Summary: 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 manufactu...