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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter F - Biologics |
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Part 607 - Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices |
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Subpart B - Procedures for Domestic Blood Product Establishments |
§ 607.21 - Times for establishment registration and blood product listing.
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§ 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]