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e-CFR data is current as of February 25, 2021

Title 21 → Chapter I → Subchapter F → Part 607 → Subpart B → §607.21

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Title 21: Food and Drugs
PART 607—ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS AND LICENSED DEVICES
Subpart B—Procedures for Domestic Blood Product Establishments

§607.21 Times for establishment registration and blood product listing.

The owner or operator of an establishment entering into an operation defined in §607.3(d) shall register such establishment within 5 days after the beginning of such operation and submit a list of every blood product in commercial distribution at the time. If the owner or operator of the establishment has not previously entered into such operation (defined in §607.3(d) of this chapter) for which a license is required, registration shall follow within 5 days after the submission of a biologics license application in order to manufacture blood products. Owners or operators of all establishments so engaged must register annually between October 1 and December 31 and must update their blood product listing every June and December.

[40 FR 52788, Nov. 12, 1975, as amended at 64 FR 56453, Oct. 20, 1999; 81 FR 60222, Aug. 31, 2016]

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