This CPG concerns the interstate shipment of biological products for use in medical emergencies. It is intended for FDA personnel and also may be used by industry. The CPG does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.
BACKGROUND: The introduction or delivery for introduction into interstate commerce of a biological product is prohibited unless there is a biologics license in effect for the product, pursuant to Section 351 of the Public Health Service Act.
Occasionally, when a medical emergency arises, an establishment may be requested to ship an unlicensed blood product interstate.
Unscheduled and infrequent interstate shipments of blood products for use in medical emergencies, for which documentation is maintained and made available for Agency examination, do not ordinarily constitute the types of transactions that would require licensure.
The Agency reserves the right to review the documentation relating to such incidents on an individual basis, to prevent the interstate shipment of unlicensed blood products under the guise of responding to a medical emergency. Such documentation must be maintained at the establishment that ships the product in response to the emergency.
If, after thorough review of all documentation and other pertinent information, the Agency determines that the incident was an attempt to circumvent the regulations, regulatory action should be considered.
Issued: 12/1/77 as 7134.12 (sic)
Revised: 10/1/80, 3/95, 8/2000
Hypertext created 2/20/2001 tc