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The New Rule At A Glance

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April 2001

  • Transfusion services must report to the FDA any biological product deviation associated with the manufacturing of blood components if the event occurred while the product was under their control and was then released to a patient.
  • Biological product deviation reports must be filed as soon as possible but no later than 45 days from the date of discovery of the possible deviation.
  • Biological product deviation reports will be subject to public disclosure under the provisions of the 1966 Freedom of Information Act.