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Business · 19/02/2015

FDA Announces Draft Guidance on Mixing, Diluting, or Repackaging Biological Products

The FDA is releasing a draft guidance outlining the circumstances under which it will not take enforcement action against pharmacies, facilities, or outsourcing companies that mix, dilute, or repack certain biological products without a license, as long as they follow specific conditions.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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