21 C.F.R. PART 607—ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS
Title 21 - Food and Drugs
Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 371, 374, 381, 393; 42 U.S.C. 262, 264, 271.
Source: 40 FR 52788, Nov. 12, 1975, unless otherwise noted.
(a) The term act means the Federal Food, Drug, and Cosmetic Act approved June 25, 1938 (52 Stat. 1040 et seq., as amended, 21 U.S.C. 301–392). (b) Blood and blood product means a drug which consists of human whole blood, plasma, or serum or any product derived from human whole blood, plasma, or serum, hereinafter referred to as “blood product.” For the purposes of this part only, blood and blood product also means those products that meet the definition of a device under the Federal Food, Drug, and Cosmetic Act and that are licensed under section 351 of the Public Health Service Act. (c) Establishment means a place of business under one management at one general physical location. The term includes, among others, human blood and plasma donor centers, blood banks, transfusion services, other blood product manufacturers and independent laboratories that engage in quality control and testing for registered blood product establishments. (d) Manufacture means the collection, preparation, processing or compatibility testing by chemical, physical, biological, or other procedures of any blood product which meets the definition of a drug as defined in section 201(g) of the act, and including manipulation, sampling, testing, or control procedures applied to the final product or to any part of the process. The term includes packaging, labeling, repackaging or otherwise changing the container, wrapper, or labeling of any blood product package in furtherance of the distribution of the blood product from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer. (e) Commercial distribution means any distribution of a blood product except under the investigational use provisions of part 312 of this chapter, but does not include internal or interplant transfer of a bulk product substance between registered establishments within the same parent, subsidiary, and/or affiliate company. For foreign establishments, the term “commercial distribution” shall have the same meaning except that the term shall not include distribution of any blood or blood product that is neither imported nor offered for import into the United States. (f) Any material change includes but is not limited to any change in the name of the blood product, in the quantity or identity of the active ingredient(s) or in the quantity or identity of the inactive ingredient(s) where quantitative listing of all ingredients is required pursuant to §607.31(a)(2) and any significant change in the labeling of a blood product. Changes that are not significant include changes in arrangement or printing or changes of an editorial nature. (g) Bulk product substance means any substance that is represented for use in a blood product and when used in the manufacturing of a blood product becomes an active ingredient or a finished dosage form of such product. (h) Advertising and labeling include the promotional material described in §202.1(l) (1) and (2) of this chapter, respectively. (i) The definitions and interpretations contained in sections 201 and 510 of the act shall be applicable to such terms when used in this part 607. (j) United States agent means a person residing or maintaining a place of business in the United States whom a foreign establishment designates as its agent. This definition excludes mailboxes, answering machines or services, or other places where an individual acting as the foreign establishment's agent is not physically present. [40 FR 52788, Nov. 12, 1975, as amended at 55 FR 11014, Mar. 26, 1990; 66 FR 59158, Nov. 27, 2001] (a) All owners or operators of establishments that engage in the manufacturing of blood products are required to register, pursuant to section 510 of the Federal Food, Drug, and Cosmetic Act. Registration and listing of blood products shall comply with this part. Registration does not permit any blood bank or similar establishment to ship blood products in interstate commerce. (b) Forms for registration of an establishment are obtainable on request from the Center for Biologics Evaluation and Research (HFM–375) (see mailing addresses in §600.2 of this chapter), or at any of the Food and Drug Administration district offices. (c) The completed form should be mailed to the Center for Biologics Evaluation and Research (HFM–375) (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 59158, Nov. 27, 2001; 70 FR 14984, Mar. 24, 2005] (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. (a) Every foreign establishment shall comply with the establishment registration and blood product listing requirements contained in subpart B of this part, unless exempt under subpart D of this part or unless the blood product enters a foreign trade zone and is re-exported from that foreign trade zone without having entered U. S. commerce. (b) No blood product may be imported or offered for import into the United States unless it is the subject of a blood product listing as required under subpart B of this part and is manufactured, prepared, propagated, compounded, or processed at a registered foreign establishment; however, this restriction does not apply to a blood product imported or offered for import under the investigational use provisions of part 312 of this chapter or to a blood product imported under section 801(d)(4) of the act. The establishment registration and blood product listing information shall be in the English language. (c) Each foreign establishment required to register under paragraph (a) of this section shall, as part of the establishment registration and blood product listing, submit the name and address of the establishment and the name of the individual responsible for submitting establishment registration and blood product listing information. Any changes in this information shall be reported to the Food and Drug Administration at the intervals specified for updating establishment registration information in §607.26 and blood product listing information in §607.30(a). (d) Each foreign establishment required to register under paragraph (a) of this section shall submit the name, address, and phone number of its United States agent as part of its initial and updated registration information in accordance with subpart B of this part. Each foreign establishment shall designate only one United States agent. (1) The United States agent shall reside or maintain a place of business in the United States. (2) Upon request from FDA, the United States agent shall assist FDA in communications with the foreign establishment, respond to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and assist FDA in scheduling inspections of the foreign establishment. If the agency is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the United States agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment. (3) The foreign establishment or the United States agent shall report changes in the United States agent's name, address, or phone number to FDA within 10-business days of the change. [66 FR 59159, Nov. 27, 2001] The following classes of persons are exempt from registration and blood product listing in accordance with this part 607 under the provisions of section 510(g)(1), (g)(2), and (g)(3) of the act, or because the Commissioner of Food and Drugs has found, under section 510(g)(5), that such registration is not necessary for the protection of the public health. The exemptions in paragraphs (a), (b), (f), and (g) of this section are limited to those classes of persons located in any State as defined in section 201(a)(1) of the act. (a) Pharmacies that are operating under applicable local laws regulating dispensing of prescription drugs and that are not manufacturing blood products for sale other than in the regular course of the practice of the profession of pharmacy including the business of dispensing and selling blood products at retail. The supplying by such pharmacies of blood products to a practitioner licensed to administer such blood products for his use in the course of his professional practice or to other pharmacies to meet temporary inventory shortages are not acts which require such pharmacies to register. (b) Practitioners who are licensed by law to prescribe or administer drugs and who manufacture blood products solely for use in the course of their professional practice. (c) Persons who manufacture blood products which are not for sale, rather, are solely for use in research, teaching, or analysis, including laboratory samples. (d) Carriers, by reason of their receipt, carriage, holding, or delivery of blood products in the usual course of business as carriers. (e) Persons who engage solely in the manufacture of in vitro diagnostic blood products and reagents not subject to licensing under section 351 of the Public Health Service Act (42 U.S.C. 262). This paragraph does not exempt such persons from registration and listing for medical devices required under part 807 of this chapter. (f) Transfusion services which are a part of a facility approved for Medicare reimbursement and engaged in the compatibility testing and transfusion of blood and blood components, but which neither routinely collect nor process blood and blood components. The collection and processing of blood and blood components in an emergency situation as determined by a responsible person and documented in writing, therapeutic collection of blood or plasma, the preparation of recovered human plasma for further manufacturing use, or preparation of red blood cells for transfusion are not acts requiring such transfusion services to register. [40 FR 52788, Nov. 12, 1975, as amended at 43 FR 37997, Aug. 25, 1978; 45 FR 85729, Dec. 30, 1980; 49 FR 34449, Aug. 31, 1984; 66 FR 31162, June 11, 2001; 66 FR 59159, Nov. 27, 2001]
Title 21: Food and Drugs
PART 607—ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS
Section Contents
§ 607.3 Definitions.
§ 607.7 Establishment registration and product listing of blood banks and other firms manufacturing human blood and blood products.
§ 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.
§ 607.40 Establishment registration and blood product listing requirements for foreign blood product establishments.
§ 607.65 Exemptions for blood product establishments.
Subpart A—General Provisions
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§ 607.3 Definitions.
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§ 607.7 Establishment registration and product listing of blood banks and other firms manufacturing human blood and blood products.
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Subpart B—Procedures for Domestic Blood Product Establishments
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§ 607.20 Who must register and submit a blood product list.
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§ 607.21 Times for establishment registration and blood product listing.
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§ 607.22 How and where to register establishments and list blood products.
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§ 607.25 Information required for establishment registration and blood product listing.
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§ 607.26 Amendments to establishment registration.
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§ 607.30 Updating blood product listing information.
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§ 607.31 Additional blood product listing information.
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§ 607.35 Notification of registrant; blood product establishment registration number and NDC Labeler Code.
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§ 607.37 Inspection of establishment registrations and blood product listings.
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§ 607.39 Misbranding by reference to establishment registration or to registration number.
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Subpart C—Procedures for Foreign Blood Product Establishments
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§ 607.40 Establishment registration and blood product listing requirements for foreign blood product establishments.
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Subpart D—Exemptions
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§ 607.65 Exemptions for blood product establishments.
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