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

Title 21Chapter ISubchapter FPart 607Subpart B → §607.30


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


§607.30   Updating blood product listing information.

(a) After submission of the initial blood product listing information, every person who is required to list blood products under §607.20 must submit electronically through the Blood Establishment Registration and Product Listing system, or any future superseding electronic system, at a minimum once in June and December of every year, the following information:

(1) A list of each blood product introduced by the registrant for commercial distribution which has not been included in any list previously submitted. All of the information required by §607.25(b) shall be provided for each such blood product.

(2) A list of each blood product formerly listed pursuant to §607.25(b) for which commercial distribution has been discontinued, including for each blood product so listed the identity by established name and proprietary name, and date of discontinuance. It is requested but not required that the reason for discontinuance of distribution be included with this information.

(3) A list of each blood product for which a notice of discontinuance was submitted pursuant to paragraph (a)(2) of this section and for which commercial distribution has been resumed, including for each blood product so listed the identity by established name as defined in section 502(e) of the act and by any proprietary name, the date of resumption, and any other information required by §607.25(b) not previously submitted.

(4) Any material change in any information previously submitted.

(b) When no changes have occurred since the previously submitted list, no listing information is required.

[40 FR 52788, Nov. 12, 1975, as amended at 81 FR 60222, Aug. 31, 2016]

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