21 CFR 607.25 - Information required for establishment registration and blood product listing.

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§ 607.25 Information required for establishment registration and blood product listing.

(a) The Blood Establishment Registration and Product Listing system requires furnishing or confirming registration information required by the Federal Food, Drug, and Cosmetic Act. This information includes the name and street address of the establishment, including post office code; a registration number if previously assigned by FDA and a Unique Facility Identifier in accordance with the system specified under section 510 of the Federal Food, Drug, and Cosmetic Act; all trade names used by the establishment; the kind of ownership or operation (that is, individually owned partnership, or corporation); and the name of the owner or operator of such establishment. The term “name of the owner or operator” must include, in the case of a partnership, the name of each partner and, in the case of a corporation, the name and title of each corporate officer and director and the name of the State of incorporation. The information required must be given separately for each establishment, as defined in § 607.3(c).

(b) The following information must also be provided:

(1) A list of blood products by established name as defined in section 502(e) of the Federal Food, Drug, and Cosmetic Act and by proprietary name, if any, which are being manufactured for commercial distribution at the identified establishment and which have not been included in any list previously submitted to FDA through the Blood Establishment Registration and Product Listing system or any future superseding electronic system.

(2) For each blood product so listed that is subject to section 351 of the Public Health Service Act, the license number of the manufacturer issued by the Center for Biologics Evaluation and Research, Food and Drug Administration.

(3) For each blood product listed, the registration number if previously assigned by FDA and the Unique Facility Identifier of the parent establishment. An establishment not owned, operated, or controlled by another firm or establishment is its own parent establishment.

[ 81 FR 60222, Aug. 31, 2016]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code

Title 21 published on 2015-12-03

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 607 after this date.

  • 2016-12-13; vol. 81 # 239 - Tuesday, December 13, 2016
    1. 81 FR 89848 - Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Correction
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; correction.
      Effective December 13, 2016.
      21 CFR Parts 20, 201, 207, 314, 514, 515, 601, 607, and 1271

Title 21 published on 2015-12-03.

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2016-12-13; vol. 81 # 239 - Tuesday, December 13, 2016
    1. 81 FR 89848 - Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Correction
      GPO FDSys: XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; correction.
      Effective December 13, 2016.
      21 CFR Parts 20, 201, 207, 314, 514, 515, 601, 607, and 1271