21 C.F.R. Subpart B—Procedures for Domestic Blood Product Establishments
Title 21 - Food and Drugs
(a) Owners or operators of all establishments, not exempt under section 510(g) of the act or subpart D of this part, that engage in the manufacture of blood products shall register and submit a list of every blood product in commercial distribution (except that registration and listing information may be submitted by the parent, subsidiary, and/or affiliate company for all establishments when operations are conducted at more than one establishment and there exists joint ownership and control among all the establishments). Blood products manufactured, prepared, propagated, compounded, or processed in any State as defined in section 201(a)(1) of the act must be listed whether or not the output of such blood product establishment or any particular blood product so listed enters interstate commerce. (b) Preparatory to engaging in the manufacture of blood products, owners or operators of establishments who are submitting a biologics license application to manufacture blood products are required to register before the biologics license application is approved. (c) No registration fee is required. Establishment registration and blood product listing do not constitute an admission or agreement or determination that a blood product is a “drug” within the meaning of section 201(g) of the act. [40 FR 52788, Nov. 12, 1975, as amended at 64 FR 56452, Oct. 20, 1999; 66 FR 59158, Nov. 27, 2001] 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 shall register annually between November 15 and December 31 and shall update their blood product listing information every June and December. [40 FR 52788, Nov. 12, 1975, as amended at 64 FR 56453, Oct. 20, 1999] (a) The first registration of an establishment shall be on Form FD–2830 (Blood Establishment Registration and Product Listing) obtainable on request from the Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research (HFM–375), (see mailing addresses in §600.2 of this chapter), or from Food and Drug Administration district offices. Subsequent annual registration shall also be accomplished on Form FD–2830, which will be furnished by the Food and Drug Administration before November 15 of each year to establishments whose product registration for that year was validated under §607.35. The completed form shall be mailed to the preceding address before December 31 of that year. (b) The first list of blood products and subsequent June and December updatings shall be on Form FD–2830, obtainable upon request as described in paragraph (a) of this section. [66 FR 59158, Nov. 27, 2001, as amended at 70 FR 14984, Mar. 24, 2005] (a) Form FD–2830 (Blood Establishment Registration and Product Listing) requires furnishing or confirming registration information required by the act. This information includes the name and street address of the establishment, including post office code; 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” shall 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 shall be given separately for each establishment, as defined in §607.3(c). (b) Form FD–2830 also requires furnishing blood product listing information required by the act as follows: (1) A list of blood products, including bulk product substances as well as finished dosage forms, by established name as defined in section 502(e) of the act and by proprietary name, which are being manufactured for commercial distribution and which have not been included in any list previously submitted on Form FD–2830 (Blood Establishment Registration and Product Listing) or Form FD–2250 (National Drug Code Directory Input). (2) For each blood product so listed which 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 of the parent establishment. An establishment not owned, operated, or controlled by another firm or establishment is its own parent establishment. [40 FR 52788, Nov. 12, 1975, as amended at 49 FR 23833, June 8, 1984; 55 FR 11013, Mar. 26, 1990; 66 FR 59158, Nov. 27, 2001] Changes in individual ownership, corporate or partnership structure, location, or blood-product handling activity shall be submitted on Form FDA–2830 (Blood Establishment Registration and Product Listing) as an amendment to registration within 5 days of such changes. Changes in the names of officers and directors of the corporations do not require such amendment but must be shown at time of annual registration. [40 FR 52788, Nov. 12, 1975, as amended at 66 FR 59158, Nov. 27, 2001] (a) After submission of the initial blood product listing information, every person who is required to list blood products pursuant to §607.20 shall submit on Form FD–2830 (Blood Establishment Registration and Product Listing) during each subsequent June and December, or at the discretion of the registrant at the time the change occurs, 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. (a) In addition to the information routinely required by §§607.25 and 607.30, the Director of the Center for Biologics Evaluation and Research may require submission of the following information by letter or by (1) For a particular blood product so listed, upon request made by the Director of the Center for Biologics Evaluation and Research for good cause, a copy of all advertisements. (2) For a particular blood product so listed, upon a finding by the Director of the Center for Biologics Evaluation and Research that it is necessary to carry out the purposes of the act, a quantitative listing of all ingredients. (3) For each registrant, upon a finding by the Director of the Center for Biologics Evaluation and Research that it is necessary to carry out the purposes of the act, a list of each listed blood product containing a particular ingredient. (b) [Reserved] [66 FR 59158, Nov. 27, 2001] (a) The Director of the Center for Biologics Evaluation and Research will provide to the registrant a validated copy of Form FD–2830 (Blood Establishment Registration and Product Listing) as evidence of registration. This validated copy will be sent to the location shown for the registering establishment, and a copy will be sent to the reporting official if at another address. A permanent registration number will be assigned to each blood product establishment registered in accordance with these regulations. (b) If a registered blood product establishment has not previously participated in the National Drug Code system, or in the National Health Related Items Code system, the National Drug Code (NDC) numbering system shall be used in assigning the first five numeric characters, otherwise known as the Labeler Code, of the 10-character NDC Code. The Labeler Code identifies the manufacturer. (c) Although establishment registration and blood product listing are required as described in §607.20, validation of registration and the assignment of a NDC Labeler Code do not, in themselves, establish that the holder of the registration is legally qualified to deal in such products. [40 FR 52788, Nov. 12, 1975, as amended at 49 FR 23833, June 8, 1984; 66 FR 59159, Nov. 27, 2001] (a) A copy of the Form FD–2830 (Blood Establishment Registration and Product Listing) filed by the registrant will be available for inspection under section 510(f) of the act, at the Department of Health and Human Services, Food and Drug Administration, Office of Communication, Training and Manufacturers' Assistance (HFM–40), Center for Biologics Evaluation and Research (see mailing addresses in §600.2 of this chapter). In addition, for domestic firms, the same information will be available for inspection at each of the Food and Drug Administration district offices for firms within the geographical area of such district office. Upon request and receipt of a self-addressed stamped envelope, verification of registration number, or location of registered establishment will be provided. The following information submitted under the blood product listing requirements is illustrative of the type of information that will be available for public disclosure when it is compiled: (1) A list of all blood products. (2) A list of all blood products manufactured by each establishment. (3) A list of blood products discontinued. (4) All data or information that has already become a matter of public knowledge. (b) Requests for information regarding blood establishment registrations and blood product listings should be directed to the Department of Health and Human Services, Food and Drug Administration, Office of Communication, Training and Manufacturers' Assistance (HFM–40), Center for Biologics Evaluation and Research (see mailing addresses in §600.2 of this chapter). [40 FR 52788, Nov. 12, 1975, as amended at 49 FR 23833, June 8, 1984; 55 FR 11014, Mar. 26, 1990; 66 FR 59159, Nov. 27, 2001; 70 FR 14984, Mar. 24, 2005] Registration of an establishment or assignment of a registration number or assignment of a NDC number does not in any way denote approval of the firm or its products. Any representation that creates an impression of official approval because of establishment registration or possession of registration number or NDC number is misleading and constitutes misbranding.
Title 21: Food and Drugs
PART 607—ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS
Subpart B—Procedures for Domestic Blood Product Establishments
§ 607.20 Who must register and submit a blood product list.
§ 607.21 Times for establishment registration and blood product listing.
§ 607.22 How and where to register establishments and list blood products.
§ 607.25 Information required for establishment registration and blood product listing.
§ 607.26 Amendments to establishment registration.
§ 607.30 Updating blood product listing information.
§ 607.31 Additional blood product listing information.
§ 607.35 Notification of registrant; blood product establishment registration number and NDC Labeler Code.
§ 607.37 Inspection of establishment registrations and blood product listings.
§ 607.39 Misbranding by reference to establishment registration or to registration number.
