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FDA Revises Regulations on Foreign and Domestic Drug Establishment Registration

The FDA has issued a final rule that reorganises, modifies and clarifies its regulations concerning how and when owners or operators of foreign and domestic establishments at which drugs are manufactured or processed must register their establishments with the FDA and list the drugs they manufacture or process. The FDA states that this rule pertains to finished drug products and to active pharmaceutical ingredients alone or together with one or more other ingredients.

Key provisions of this final rule include the following.

  • requires electronic submission (unless waived in certain circumstances) of registration and listing information
  • makes clear that the establishment registration and listing obligation rests with persons who manufacture, repack, relabel or salvage drug products
  • does not require persons who act only as private label distributors of drug products to register establishments or list drugs but allows them to submit drug listing information as agents acting on behalf of persons who manufacture, repack, relabel or salvage drug products
  • specifies that registrants must review and update registration information between 1 October and 31 December each year
  • make several adjustments to the timing and substance of the submission of information to register a drug establishment and list drugs manufactured, repacked, relabelled or salvaged at the establishment
  • provides that, with certain exceptions, establishment registration and drug listing information is generally available for public disclosure
  • includes revised definitions of the terms “active pharmaceutical ingredient,” “commercial distribution,” “content of labelling,” “importer,” “manufacture,” “private label distributor,” “relabel,” “repack” and “representative sampling of any other labelling”
  • requires registrants to propose national drug codes for FDA assignment to listed drugs
  • provides that a product may be deemed to be misbranded if an NDC is used improperly
  • drops proposed requirements that (i) the NDC appear in human-readable form on the label of each listed drug and (ii) foreign establishments identify importers when listing drugs they manufacture, repack, relabel or salvage

This rule will be effective as of 30 November and the FDA encourages registrants to comply as soon as possible thereafter. However, because this rule introduces new requirements and some registrants will need to adjust their registration and listing activities, the FDA intends to exercise enforcement discretion between 30 November and the compliance deadlines set forth in this rule.

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