Food and Drug Administration, HHS § 606.3

a biological product, FDA will so no- Subpart I—Records and Reports tify the applicant. Ordinarily, for bio- 606.160 Records. logical products approved under 606.165 Distribution and receipt; procedures § 601.91, these requirements will no and records. longer apply when FDA determines 606.170 Adverse reaction file. that the postmarketing study verifies 606.171 Reporting of product deviations by and describes the biological product’s licensed manufacturers, unlicensed reg- clinical benefit. For biological prod- istered establishments, and trans- ucts approved under § 601.91, the re- fusion services. strictions would no longer apply when AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 355, FDA determines that safe use of the bi- 360, 360j, 371, 374; 42 U.S.C. 216, 262, 263a, 264. ological product can be ensured SOURCE: 40 FR 53532, Nov. 18, 1975, unless through appropriate labeling. FDA also otherwise noted. retains the discretion to remove spe- cific postapproval requirements upon Subpart A—General Provisions review of a petition submitted by the sponsor in accordance with § 10.30 of § 606.3 Definitions. this chapter. As used in this part: (a) Blood means a product that is a PART 606—CURRENT GOOD MAN- fluid containing dissolved and sus- UFACTURING PRACTICE FOR pended elements which was collected BLOOD AND BLOOD COMPO- from the vascular system of a human. NENTS (b) Unit means the volume of blood or one of its components in a suitable vol- Subpart A—General Provisions ume of anticoagulant obtained from a single collection of blood from one Sec. donor. 606.3 Definitions. (c) Blood component means a product containing a part of human blood sepa- Subpart B—Organization and Personnel rated by physical or mechanical means. 606.20 Personnel. (d) Plasma for further manufacturing means that liquid portion of blood sep- Subpart C—Plant and Facilities arated and used as material to prepare another product. 606.40 Facilities. (e) means the proce- dure in which blood is removed from Subpart D—Equipment the donor, the plasma is separated 606.60 Equipment. from the formed elements and at least 606.65 Supplies and reagents. the red blood cells are returned to the donor. Subpart E [Reserved] (f) means the proce- dure in which blood is removed from a Subpart F—Production and Process donor, a concentrate is sepa- Controls rated, and the remaining formed ele- 606.100 Standard operating procedures. ments are returned to the donor along 606.110 Plateletpheresis, leukapheresis, and with a portion of the residual plasma. plasmapheresis. (g) Leukapheresis means the proce- dure in which blood is removed from Subpart G—Additional Labeling Standards the donor, a leukocyte concentrate is for Blood and Blood Components separated, and the remaining formed 606.120 Labeling, general requirements. elements and residual plasma are re- 606.121 Container label. turned to the donor. 606.122 Circular of information. (h) Facilities means any area used for the collection, processing, compat- Subpart H—Laboratory Controls ibility testing, storage or distribution 606.140 Laboratory controls. of blood and blood components. 606.145 Control of bacterial contamination (i) Processing means any procedure of . employed after collection, and before 606.151 Compatibility testing. or after compatibility testing of blood,

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and includes the identification of a provisions of this part to their respec- unit of donor blood, the preparation of tive functions. components from such unit of donor (c) Persons whose presence can ad- blood, serological testing, labeling and versely affect the safety and purity of associated recordkeeping. the products shall be excluded from (j) Compatibility testing means the areas where the collection, processing, procedures performed to establish the compatibility testing, storage or dis- matching of a donor’s blood or blood tribution of blood or blood components components with that of a potential re- is conducted. cipient. [40 FR 53532, Nov. 18, 1975, as amended at 49 (k) Distributed means: FR 23833, June 8, 1984; 55 FR 11014, Mar. 26, (1) The blood or blood components 1990; 62 FR 53538, Oct. 15, 1997] have left the control of the licensed manufacturer, unlicensed registered Subpart C—Plant and Facilities blood establishment, or transfusion service; or § 606.40 Facilities. (2) The licensed manufacturer has Facilities shall be maintained in a provided Source Plasma or any other clean and orderly manner, and shall be blood component for use in the manu- of suitable size, construction and loca- facture of a licensed biological product. tion to facilitate adequate cleaning, (l) means having responsi- Control maintenance and proper operations. bility for maintaining the continued The facilities shall: safety, purity, and potency of the prod- (a) Provide adequate space for the uct and for compliance with applicable following when applicable: product and establishment standards, (1) Private and accurate examina- and for compliance with current good tions of individuals to determine their manufacturing practices. eligibility as blood donors. [40 FR 53532, Nov. 18, 1975, as amended at 64 (2) The withdrawal of blood from do- FR 45370, Aug. 19, 1999; 65 FR 66635, Nov. 7, nors with minimal risk of contamina- 2000; 66 FR 1835, Jan. 10, 2001; 66 FR 40889, tion, or exposure to activities and Aug. 6, 2001; 72 FR 45886, Aug. 16, 2007; 80 FR equipment unrelated to blood collec- 29894, May 22, 2015] tion. (3) The storage of blood or blood com- Subpart B—Organization and ponents pending completion of tests. Personnel (4) The quarantine storage of blood or blood components in a designated loca- § 606.20 Personnel. tion pending repetition of those tests (a) [Reserved] that initially gave questionable sero- (b) The personnel responsible for the logical results. collection, processing, compatibility (5) The storage of finished products testing, storage or distribution of blood prior to distribution. or blood components shall be adequate (6) The quarantine storage, handling in number, educational background, and disposition of products and re- training and experience, including pro- agents not suitable for use. fessional training as necessary, or com- (7) The orderly collection, processing, bination thereof, to assure competent compatibility testing, storage and dis- performance of their assigned func- tribution of blood and blood compo- tions, and to ensure that the final nents to prevent contamination. product has the safety, purity, po- (8) The adequate and proper perform- tency, identity and effectiveness it pur- ance of all steps in plasmapheresis, ports or is represented to possess. All plateletpheresis and leukapheresis pro- personnel shall have capabilities com- cedures. mensurate with their assigned func- (9) The orderly conduction of all tions, a thorough understanding of the packaging, labeling and other finishing procedures or control operations they operations. perform, the necessary training or ex- (b) Provide adequate lighting, ven- perience, and adequate information tilation and screening of open windows concerning the application of pertinent and doors.

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(c) Provide adequate, clean, and con- Subpart D—Equipment venient handwashing facilities for per- sonnel, and adequate, clean, and con- § 606.60 Equipment. venient toilet facilities for donors and (a) Equipment used in the collection, personnel. Drains shall be of adequate processing, compatibility testing, stor- size and, where connected directly to a age and distribution of blood and blood sewer, shall be equipped with traps to components shall be maintained in a prevent back-siphonage. clean and orderly manner and located (d) Provide for safe and sanitary dis- so as to facilitate cleaning and mainte- posal for the following: nance. The equipment shall be ob- (1) Trash and items used during the served, standardized and calibrated on collection, processing and compat- a regularly scheduled basis as pre- ibility testing of blood and blood com- scribed in the Standard Operating Pro- ponents. cedures Manual and shall perform in (2) Blood and blood components not the manner for which it was designed so as to assure compliance with the of- suitable for use or distribution. ficial requirements prescribed in this [40 FR 53532, Nov. 18, 1975, as amended at 80 chapter for blood and blood products. FR 29895, May 22, 2015] (b) Equipment that shall be observed, standardized and calibrated with at least the following frequency, include but are not limited to:

Equipment Performance check Frequency Frequency of calibration

Temperature recorder .... Compare against thermometer ...... Daily ...... As necessary. Refrigerated centrifuge .. Observe speed and temperature ...... Each day of use Do. Hematocrit centrifuge ...... Standardize before initial use, after re- pairs or adjustments, and annually. Timer every 3 mo. General lab centrifuge ...... Tachometer every 6 mo. Automated blood-typing Observe controls for correct results ..... Each day of use. machine. Hemoglobinometer ...... Standardize against ...... do. cyanmethemoglobin standard. Refractometer ...... Standardize against distilled water ...... do. Blood container scale .... Standardize against container of known ...... do ...... As necessary. weight. Water bath ...... Observe temperature ...... do ...... Do. Rh view box ...... do ...... do ...... Do. Autoclave ...... do ...... Each time of use Do. Serologic rotators ...... Observe controls for correct results ..... Each day of use Speed as necessary. Laboratory thermom- ...... Before initial use. eters. Electronic thermometers ...... Monthly. Vacuum blood agitator .. Observe weight of the first container of Each day of use Standardize with container of known blood filled for correct results. mass or volume before initial use, and after repairs or adjustments.

(c) Equipment employed in the steri- attained temperature of 170 °C (338 °F) lization of materials used in blood col- maintained for 2 hours with dry heat. lection or for disposition of contami- [40 FR 53532, Nov. 18, 1975; 40 FR 55849, Dec. nated products shall be designed, main- 2, 1975, as amended at 45 FR 9261, Feb. 12, tained and utilized to ensure the de- 1980; 57 FR 11263, Apr. 2, 1992; 57 FR 12862, struction of contaminating microorga- Apr. 13, 1992] nisms. The effectiveness of the steri- § 606.65 Supplies and reagents. lization procedure shall be no less than that achieved by an attained tempera- All supplies and reagents used in the ture of 121.5 °C (251 °F) maintained for collection, processing, compatibility 20 minutes by saturated steam or by an testing, storage and distribution of blood and blood components shall be stored in a safe, sanitary and orderly manner.

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(a) All surfaces coming in contact Subpart F—Production and with blood and blood components in- Process Controls tended for transfusion shall be sterile, pyrogen-free, and shall not interact § 606.100 Standard operating proce- with the product in such a manner as dures. to have an adverse effect upon the safe- (a) In all instances, except clinical ty, purity, potency or effectiveness of investigations, standard operating pro- the product. All final containers and cedures shall comply with published closures for blood and blood compo- additional standards in part 640 of this nents not intended for transfusion chapter for the products being proc- shall be clean and free of surface solids essed; except that, references in part and other contaminants. 640 relating to licenses, licensed estab- (b) Each blood collecting container lishments and submission of material and its satellite container(s), if any, or data to or approval by the Director, shall be examined visually for damage Center for Biologics Evaluation and or evidence of contamination prior to Research, are not applicable to estab- its use and immediately after filling. lishments not subject to licensure Such examination shall include inspec- under section 351 of the Public Health tion for breakage of seals, when indi- Service Act. cated, and abnormal discoloration. (b) Establishments must establish, Where any defect is observed, the con- maintain, and follow written standard tainer shall not be used, or, if detected operating procedures for all steps in after filling, shall be properly dis- the collection, processing, compat- carded. ibility testing, storage, and distribu- (c) Representative samples of each tion of blood and blood components for lot of the following reagents or solu- allogeneic transfusion, autologous tions shall be tested on a regularly transfusion, and further manufacturing scheduled basis by methods described purposes; for all steps in the investiga- in the Standard Operating Procedures tion of product deviations related to Manual to determine their capacity to § 606.171; and for all steps in record- perform as required: keeping related to current good manu- facturing practice and other applicable Reagent or solution Frequency of testing requirements and standards. Such pro- cedures must be available to the per- Anti-human globulin ...... Each day of use. Blood grouping reagents ...... Do. sonnel for use in the areas where the Lectins ...... Do. procedures are performed. The written Antibody screening and re- Do. standard operating procedures must in- verse grouping cells. clude, but are not limited to, descrip- Hepatitis test reagents ...... Each run. tions of the following, when applicable: Syphilis serology reagents .... Do. Enzymes ...... Each day of use. (1) Criteria used to determine donor eligibility, including acceptable med- (d) Supplies and reagents that do not ical history criteria. bear an expiration date shall be stored (2) Methods of performing donor in such a manner that the oldest is qualifying tests and measurements, in- used first. cluding minimum and maximum values (e) Supplies and reagents shall be for a test or procedure when a factor in used in a manner consistent with in- determining acceptability. structions provided by the manufac- (3) Solutions and methods used to turer. prepare the site of phlebotomy to give (f) Items that are required to be ster- maximum assurance of a sterile con- ile and come into contact with blood tainer of blood. should be disposable whenever possible. (4) Method of accurately relating the product(s) to the donor. [40 FR 53532, Nov. 18, 1975, as amended at 59 (5) Blood collection procedure, in- FR 23636, May 6, 1994] cluding in-process precautions taken to measure accurately the quantity of Subpart E [Reserved] blood removed from the donor. 48

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(6) Methods of component prepara- by such a donor that are intended for tion, including any time restrictions use in another person or further manu- for specific steps in processing. facture into injectable products, except (7) All tests and repeat tests per- pooled components intended solely for formed on blood and blood components further manufacturing into products during manufacturing. that are manufactured using validated (8) Pretransfusion testing, where ap- viral clearance procedures; plicable, including precautions to be (iii) To notify consignees to quar- taken to identify accurately the recipi- antine in-date blood and blood compo- ent blood samples and crossmatched nents previously donated by such a donor units. donor intended for use in another per- (9) Procedures for investigating ad- son or for further manufacture into verse donor and recipient reactions. injectable products, except pooled com- (10) Storage temperatures and meth- ponents intended solely for further ods of controlling storage temperatures manufacturing into products that are for all blood products and reagents as manufactured using validated viral prescribed in §§ 600.15 and 610.53 of this clearance procedures; chapter. (iv) To determine the suitability for (11) Length of expiration dates, if release, destruction, or relabeling of any, assigned for all final products as quarantined in-date blood and blood prescribed in § 610.53 of this chapter. components; (12) Criteria for determining whether (v) To notify consignees of the re- returned blood is suitable for reissue. sults of the HIV or HCV testing per- (13) Procedures used for relating a formed on the donors of such blood and unit of blood or blood component from blood components; the donor to its final disposition. (14) Quality control procedures for (vi) To notify the transfusion recipi- supplies and reagents employed in ent, the recipient’s physician of record, blood collection, processing and or the recipient’s legal representative pretransfusion testing. that the recipient received blood or (15) Schedules and procedures for blood components at increased risk of equipment maintenance and calibra- transmitting HIV or HCV, respectively. tion. (20) Procedures for donor deferral as (16) Labeling procedures, including prescribed in § 610.41 of this chapter. safeguards to avoid labeling mixups. (21) Procedures for donor notification (17) Procedures of plasmapheresis, and notification of the referring physi- plateletpheresis, and leukapheresis, if cian of an autologous donor, including performed, including precautions to be procedures for the appropriate followup taken to ensure reinfusion of a donor’s if the initial attempt at notification own cells. fails, as prescribed in § 630.40 of this (18) Procedures for preparing recov- chapter. ered plasma, if performed, including (22) Procedures to control the risks of details of separation, pooling, labeling, bacterial contamination of platelets, storage, and distribution. including all steps required under (19) Procedures under §§ 610.46 and § 606.145. 610.47 of this chapter: (c) All records pertinent to the lot or (i) To identify previously donated unit maintained pursuant to these reg- blood and blood components from a ulations shall be reviewed before the donor who later tests reactive for evi- release or distribution of a lot or unit dence of human immunodeficiency of final product. The review or portions virus (HIV) infection or hepatitis C of the review may be performed at ap- virus (HCV) infection when tested propriate periods during or after blood under § 610.40 of this chapter, or when a collecting, processing, compatibility blood establishment is made aware of testing and storing. A thorough inves- other reliable test results or informa- tigation, including the conclusions and tion indicating evidence of HIV or HCV followup, of any unexplained discrep- infection; ancy or the failure of a lot or unit to (ii) To quarantine in-date blood and meet any of its specifications shall be blood components previously donated made and recorded.

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(d) In addition to the requirements of Subpart G—Additional Labeling this subpart and in conformity with Standards for Blood and this section, any facility may utilize Blood Components current standard operating procedures such as the manuals of the organiza- § 606.120 Labeling, general require- tions, as long as such specific proce- ments. dures are consistent with, and at least (a) Labeling operations shall be sepa- as stringent as, the requirements con- rated physically or spatially from tained in this part. other operations in a manner adequate (1) American Association of Blood to prevent mixups. Banks. (b) The labeling operation shall in- (2) American National Red Cross. clude the following labeling controls: (3) Other organizations or individual (1) Labels shall be held upon receipt, blood banks, subject to approval by the pending review and proofing against an Director, Center for Biologics Evalua- approved final copy, to ensure accuracy tion and Research. regarding identity, content, and con- formity with the approved copy. [40 FR 53532, Nov. 18, 1975, as amended at 49 (2) Each type of label representing FR 23833, June 8, 1984; 55 FR 11013, Mar. 26, 1990; 61 FR 47422, Sept. 9, 1996; 64 FR 45370, different products shall be stored and Aug. 19, 1999; 66 FR 31176, June 11, 2001; 72 FR maintained in a manner to prevent 48798, Aug. 24, 2007; 80 FR 80651, Dec. 28, 2015; mixups, and stocks of obsolete labels 80 FR 29895, May 22, 2015] shall be destroyed. (3) All necessary checks in labeling § 606.110 Plateletpheresis, procedures shall be utilized to prevent leukapheresis, and plasmapheresis. errors in translating test results to (a) The use of plateletpheresis and container labels. leukapheresis procedures to obtain a (c) All labeling shall be clear and leg- product for a specific recipient may be ible. at variance with the additional stand- [50 FR 35469, Aug. 30, 1985] ards for specific products prescribed in this part provided that: (1) A physician § 606.121 Container label. has determined that the recipient must (a) The container label requirements be transfused with the leukocytes or are designed to facilitate the use of a platelets from a specific donor, and (2) uniform container label for blood and the procedure is performed under the blood components intended for use in supervision of a responsible physician transfusion or further manufacture by who is aware of the health status of the all blood establishments. donor, and the physician has deter- (b) The label provided by the col- mined and documented that the do- lecting facility and the initial proc- nor’s health permits plateletpheresis or essing facility must not be removed, al- leukapheresis. tered, or obscured, except that the (b) Plasmapheresis of donors who do label may be altered to indicate the not meet the donor requirements of proper name of the product, with any §§ 630.10, 630.15, 640.64 and 640.65 of this appropriate modifiers and attributes, chapter for the collection of plasma and other information required to iden- containing rare antibodies shall be per- tify accurately the contents of a con- mitted only with the prior approval of tainer after blood components consid- the Director, Center for Biologics Eval- ered finished products have been pre- uation and Research. pared. (c) The container label must include [40 FR 53532, Nov. 18, 1975, as amended at 49 the following information, as well as FR 23833, June 8, 1984; 55 FR 11013, Mar. 26, other specialized information as re- 1990; 80 FR 29895, May 22, 2015] quired in this section for specific prod- ucts: (1) The proper name of the product in a prominent position, with any appro- priate modifiers and attributes.

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(2) The name, address, unique facility (C) Benefits, such as time off from identifier, and, if a licensed product, work, membership in blood assurance the license number of each manufac- programs, and cancellation of non- turer; except the container label for replacement fees that are not readily blood and blood components for further convertible to cash, do not constitute manufacture is not required to include monetary payment within the meaning a unique facility identifier. of this paragraph. (3) The donor or lot number relating (9) If the product is intended for the unit to the donor. If pooled, all transfusion or as is otherwise appro- donor numbers, all donation numbers, priate, the ABO group and Rh type of or a pool number that is traceable to the donor must be designated conspicu- each individual unit comprising the ously. For Cryoprecipitated pool. Antihemophiliac Factor (AHF), the Rh (4)(i) The expiration date, including type may be omitted. The Rh type the day, month, and year, and, if the must be designated as follows: dating period for the product is 72 (i) If the test using Anti-D Blood hours or less, including any product Grouping Reagent is positive, the prod- prepared in a system that might com- uct must be labeled: ‘‘Rh positive.’’ promise sterility, the hour of expira- (ii) If the test using Anti-D Blood tion. Grouping Reagent is negative, but the (ii) If Source Plasma intended for test for weak D (formerly D ) is posi- manufacturing into noninjectable u tive, the product must be labeled: ‘‘Rh products is pooled, the expiration date positive.’’ for the pool is determined from the col- lection date of the oldest unit in the (iii) If the test using Anti-D Blood pool, and the pooling records must Grouping Reagent is negative and the show the collection date for each unit test for weak D (formerly Du) is nega- in the pool. tive, the product must be labeled: ‘‘Rh (5) For , Plasma, Plate- negative.’’ lets, and partial units of Red Blood (10) If the product is not intended for Cells, the volume of the product, accu- transfusion, a statement as applicable: rate to within ±10 percent; or option- ‘‘Caution: For Manufacturing Use ally for Platelets, the volume or vol- Only,’’ or ‘‘Caution: For Use in Manu- ume range within reasonable limits. facturing Noninjectable Products (6) Where applicable, the name and Only,’’ or other cautionary statement volume of source material. as approved by the Director, Center for (7) The recommended storage tem- Biologics Evaluation and Research perature (in degrees Celsius). (CBER). (8) If the product is intended for (11) If the product is intended for fur- transfusion, the statements: ther manufacturing use, a statement (i) ‘‘Rx only.’’ listing the results of all the tests for (ii) ‘‘See circular of information for relevant transfusion-transmitted infec- indications, contraindications, cau- tions required under § 610.40 of this tions, and methods of infusion.’’ chapter for which the donation has (iii) ‘‘Properly identify intended re- been tested and found negative; except cipient.’’ that the container label for Source (iv) ‘‘This product may transmit in- Plasma is not required to list the nega- fectious agents.’’ tive results of serological syphilis test- (v) The appropriate donor classifica- ing under § 640.65(b) of this chapter. tion statement, i.e., ‘‘paid donor’’ or (12) The blood and blood components ‘‘volunteer donor,’’ in no less promi- must be labeled in accordance with nence than the proper name of the § 610.40 of this chapter, when the dona- product. tion is tested and demonstrates evi- (A) A paid donor is a person who re- dence of infection due to a relevant ceives monetary payment for a -transmitted infection(s). donation. (13) The container label of blood or (B) A volunteer donor is a person who blood components intended for trans- does not receive monetary payment for fusion must bear encoded information a . in a format that is machine-readable

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and approved for use by the Director, outline on a white background for CBER. ABO. (i) Who is subject to this machine-read- (2) The proper name of the product, able requirement? All blood establish- with any appropriate modifiers and at- ments that manufacture, process, re- tributes, the donor classification state- pack, or relabel blood or blood compo- ment, and the statement ‘‘properly nents intended for transfusion and reg- identify intended recipient’’ may be ulated under the Federal Food, Drug, printed in solid red or in solid black. and Cosmetic Act or the Public Health (3) The following color scheme may Service Act. be used for differentiating ABO Blood (ii) What blood products are subject to groups: this machine-readable requirement? All Color of blood and blood components intended Blood group label for transfusion are subject to the ma- chine-readable information label re- O ...... Blue A ...... Yellow quirement in this section. B ...... Pink (iii) What information must be ma- AB ...... White chine-readable? Each label must have machine-readable information that (4) Special labels, such as those de- contains, at a minimum: scribed in paragraphs (h) and (i) of this (A) A unique facility identifier; section, may be color-coded. (B) Lot number relating to the donor; (e) Container label requirements for (C) Product code; and particular products or groups of prod- ucts. (D) ABO and Rh of the donor, except (1) Whole Blood labels must include: as described in paragraphs (c)(9) and (i) The name of the applicable anti- (i)(5) of this section. coagulant approved for use by the Di- (iv) How must the machine-readable in- rector, CBER. formation appear? The machine-read- (ii) The volume of anticoagulant. able information must: (iii) If tests for unexpected antibodies (A) Be unique to the blood or blood are positive, blood intended for trans- component; fusion must be labeled: ‘‘Contains (B) Be surrounded by sufficient blank (name of antibody).’’ space so that the machine-readable in- (2) Except for frozen, deglycerolized, formation can be scanned correctly; or washed products, Red and Blood Cell labels must include: (C) Remain intact under normal con- (i) The type of anticoagulant, and if ditions of use. applicable, the volume of Whole Blood (v) Where does the machine-readable in- and type of additive solution, with formation go? The machine-readable in- which the product was prepared. formation must appear on the label of (ii) If tests for unexpected antibodies any blood or blood component which is are positive and the product is in- or can be transfused to a patient or tended for transfusion, the statement: from which the blood or blood compo- ‘‘Contains (name of antibody).’’ nent can be taken and transfused to a (3) If tests for unexpected antibodies patient. are positive, Plasma intended for (d) Unless otherwise approved by the transfusion must be labeled: ‘‘Contains Director, CBER, the container label for (name of antibody).’’ blood and blood components intended (4) Recovered plasma labels must in- for transfusion must be white and print clude: must be solid black, with the following (i) In lieu of an expiration date, the additional exceptions: date of collection of the oldest mate- (1) The ABO and Rh blood groups rial in the container. must be printed as follows: (ii) For recovered plasma not meet- (i) Rh positive: Use black print on ing the requirements for manufacture white background and use solid black into licensable products, the state- or other solid color for ABO. ment: ‘‘Not for Use in Products Subject (ii) Rh negative: Use white print on to License Under Section 351 of the black background for Rh and use black Public Health Service Act.’’

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(iii) The type of anticoagulant with (h) The following additional informa- which the product was prepared. tion must appear on the label for blood (5) Source Plasma labels must in- and blood components shipped in an clude the following information: emergency prior to completion of re- (i) The cautionary statement, as quired tests, in accordance with specified in paragraph (c)(10) of this § 610.40(g) of this chapter: section, must follow the proper name (1) The statement: ‘‘FOR EMER- with any appropriate modifiers and at- GENCY USE ONLY BY ll .’’ tributes and be of similar prominence (2) Results of any tests prescribed as the proper name. under §§ 610.40 and 640.5(b) or (c) of this (ii) The statement ‘‘Store at ¥20 °C chapter completed before shipment. or colder,’’ provided, that where plas- (3) Indication of any tests prescribed ma is intended for manufacturing into under §§ 610.40 and 640.5(b) or (c) of this noninjectable products, this statement chapter not completed before ship- may be replaced by a statement of the ment. temperature appropriate for manufac- (i) The following additional informa- ture of the final product to be prepared tion must appear on the label for blood from the plasma. and blood components intended for (iii) The total volume or weight of autologous transfusion: plasma and total quantity and type of (1) Information adequately identi- anticoagulant used. fying the patient, e.g., name, date of (iv) When plasma collected from a birth, hospital, and identification num- donor is reactive for a serologic test for ber. syphilis, a statement that the plasma (2) Date of donation. is reactive and must be used only for (3) The statement: ‘‘AUTOLOGOUS the manufacturing of positive control DONOR.’’ reagents for the serologic test for (4) The ABO and Rh blood group and syphilis. type, except as provided in paragraph (v) Source Plasma diverted for (c)(9) of this section. Source Plasma Salvaged must be re- (5) Each container of blood and blood labeled ‘‘Source Plasma Salvaged’’ as component intended for autologous use prescribed in § 640.76 of this chapter. and obtained from a donor who fails to Immediately following the proper meet any of the donor eligibility re- name of the product, with any appro- quirements under § 630.10 of this chap- priate modifiers and attributes, the la- ter or who is reactive to or positive for beling must prominently state as appli- one or more tests for evidence of infec- cable, ‘‘STORAGE TEMPERATURE tion due to relevant transfusion-trans- EXCEEDED ¥20 °C’’ or ‘‘SHIPPING mitted infections under § 610.40 of this TEMPERATURE EXCEEDED ¥5 °C.’’ chapter must be prominently and per- (vi) A statement as to whether the manently labeled ‘‘FOR AUTOLOGOUS plasma was collected from normal do- USE ONLY’’ and as otherwise required nors, or from donors in specific collec- under § 610.40 of this chapter. Such tion programs approved by the Direc- units also may have the ABO and Rh tor, CBER. In the case of specific col- blood group and type on the label. lection programs, the label must state (6) Units of blood and blood compo- the defining characteristics of the plas- nents originally intended for ma. In the case of immunized donors, autologous use, except those labeled as the label must state the immunizing prescribed under paragraph (i)(5) of this antigen. section, may be issued for allogeneic (f) Blood and blood components de- transfusion provided the container termined to be unsuitable for trans- label complies with all applicable pro- fusion must be prominently labeled visions of paragraphs (b) through (e) of ‘‘NOT FOR TRANSFUSION,’’ and the this section. In such case, the special label must state the reason the unit is label required under paragraphs (i)(1), considered unsuitable. The provision (i)(2), and (i)(3) of this section must be does not apply to blood and blood com- removed or otherwise obscured. ponents intended solely for further (j) A tie-tag attached to the con- manufacture. tainer may be used for providing the (g) [Reserved] information required by paragraphs

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(e)(1)(iii), (e)(2)(ii), and (e)(3), (h), or (1) The approximate volume of plas- (i)(1), (i)(2), and (i)(3) of this section. ma from which a sample unit of Plate- lets is prepared. [77 FR 16, Jan. 3, 2012, as amended at 80 FR (2) Instructions to begin administra- 29895, May 22, 2015] tion as soon as possible, but not more § 606.122 Circular of information. than 4 hours after entering the con- tainer. A circular of information must be (m) For Plasma, the circular of infor- available for distribution if the product mation must contain: is intended for transfusion. The cir- (1) A warning against further proc- cular of information must provide ade- essing of the frozen product if there is quate directions for use, including the evidence of breakage or thawing. following information: (2) Instructions to thaw the frozen (a) Instructions to mix the product product at a temperature appropriate before use. for the product. (b) Instructions to use a filter in the (3) When applicable, instructions to administration equipment. begin administration of the product (c) The statement ‘‘Do Not Add Medi- within a specified time after thawing. cations’’ or an explanation concerning (4) Instructions to administer to allowable additives. ABO-group-compatible recipients. (d) A description of the product, its (5) A statement that this product has source, and preparation, including the the same risk of transmitting infec- name and proportion of the anticoagu- tious agents as Whole Blood; other lant used in collecting the Whole volume expanders without this from each product is prepared. risk are available for treating (e) A statement that the product was hypovolemia. prepared from blood that was found (n) For Cryoprecipitated AHF, the negative when tested for relevant circular of information must contain: transfusion-transmitted infections, as (1) A statement that the average po- required under § 610.40 of this chapter tency is 80 or more International Units (include each test that was performed). of antihemophilic factor. (f) The statement: ‘‘Warning: The (2) The statement: ‘‘Usually contains risk of transmitting infectious agents at least 150 milligrams of fibrinogen’’; is present. Careful donor selection and or, alternatively, the average available laboratory tests do not elimi- fibrinogen level determined by assay of nate the hazard.’’ representative units. (g) The names of cryoprotective (3) A warning against further proc- agents and other additives that may essing of the product if there is evi- still be present in the product. dence of breakage or thawing. (4) Instructions to thaw the product (h) The names and results of all tests for no more than 15 minutes at a tem- performed when necessary for safe and perature of between 30 and 37 °C. effective use. (5) Instructions to store at room tem- (i) The use of the product, indica- perature after thawing and to begin ad- tions, contradications, side effects and ministration as soon as possible but no hazards, dosage and administration more than 4 hours after entering the recommendations. container or after pooling and within 6 (j) [Reserved] hours after thawing. (k) For Red Blood Cells, the circular (6) A statement that 0.9 percent So- of information must contain: dium Chloride Injection U.S.P. is the (1) Instructions to administer a suit- preferred diluent. able plasma volume expander if Red (7) Adequate instructions for pooling Blood Cells are substituted when Whole to ensure complete removal of all con- Blood is the indicated product. centrated material from each con- (2) A warning not to add Lactated tainer. Ringer’s Injection U.S.P. solution to (8) The statement: ‘‘Good patient Red Blood Cell products. management requires monitoring (l) For Platelets, the circular of in- treatment responses to formation must contain: Cryoprecipitated AHF transfusions

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with periodic plasma factor VIII or lishment or a laboratory to identify fibrinogen assays in hemophilia A and the organism. The transfusion service hypofibrinogenemic recipients, respec- must further notify the blood collec- tively.’’ tion establishment either by providing [50 FR 35470, Aug. 30, 1985, as amended at 53 information about the species of the FR 116, Jan. 5, 1988; 64 FR 45371, Aug. 19, 1999; contaminating organism when the 77 FR 18, Jan. 3, 2012; 80 FR 29895, May 22, transfusion service has been able to 2015] identify it, or by advising the blood collection establishment when the Subpart H—Laboratory Controls transfusion service has determined that the species cannot be identified. § 606.140 Laboratory controls. (d) In the event that a contaminating Laboratory control procedures shall organism is identified under paragraph include: (b) or (c) of this section, the collection (a) The establishment of scientif- establishment’s responsible physician, ically sound and appropriate specifica- as defined in § 630.3(i) of this chapter, tions, standards and test procedures to must determine whether the contami- assure that blood and blood compo- nents are safe, pure, potent and effec- nating organism is likely to be associ- tive. ated with a bacterial infection that is (b) Adequate provisions for moni- endogenous to the bloodstream of the toring the reliability, accuracy, preci- donor, in accordance with a standard sion and performance of laboratory operating procedure developed under test procedures and instruments. § 606.100(b)(22). This determination may (c) Adequate identification and han- not be further delegated. dling of all test samples so that they [80 FR 29895, May 22, 2015] are accurately related to the specific unit of product being tested, or to its § 606.151 Compatibility testing. donor, or to the specific recipient, where applicable. Standard operating procedures for compatibility testing shall include the § 606.145 Control of bacterial contami- following: nation of platelets. (a) A method of collecting and identi- (a) Blood collection establishments fying the blood samples of recipients to and transfusion services must assure ensure positive identification. that the risk of bacterial contamina- (b) The use of fresh recipient serum tion of platelets is adequately con- or plasma samples less than 3 days old trolled using FDA approved or cleared for all pretransfusion testing if the re- devices or other adequate and appro- cipient has been pregnant or transfused priate methods found acceptable for within the previous 3 months. this purpose by FDA. (c) Procedures to demonstrate incom- (b) In the event that a blood collec- patibility between the donor’s cell type tion establishment identifies platelets as bacterially contaminated, that es- and the recipient’s serum or plasma tablishment must not release for trans- type. fusion the product or any other compo- (d) A provision that, if the unit of do- nent prepared from the same collec- nor’s blood has not been screened by a tion, and must take appropriate steps method that will demonstrate aggluti- to identify the organism. nating, coating and hemolytic anti- (c) In the event that a transfusion bodies, the recipient’s cells shall be service identifies platelets as tested with the donor’s serum (minor bacterially contaminated, the trans- crossmatch) by a method that will so fusion service must not release the demonstrate. product and must notify the blood col- (e) Procedures to expedite trans- lection establishment that provided fusion in life-threatening emergencies. the platelets. The transfusion service Records of all such incidents shall be must take appropriate steps to identify maintained, including complete docu- the organism; these steps may include mentation justifying the emergency contracting with the collection estab-

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action, which shall be signed by a phy- notification of a transfusion recipient, sician. the recipient’s physician of record, or the recipient’s legal representative; [40 FR 53532, Nov. 18, 1975, as amended at 64 FR 45371, Aug. 19, 1999; 66 FR 1835, Jan. 10, and disposition. 2001; 66 FR 40889, Aug. 6, 2001] (ix) The donor’s postal address pro- vided at the time of donation where the Subpart I—Records and Reports donor may be contacted within 8 weeks after donation. § 606.160 Records. (x) Records of notification of donors (a)(1) Records shall be maintained deferred or determined not to be eligi- concurrently with the performance of ble for donation, including appropriate each significant step in the collection, followup if the initial attempt at noti- processing, compatibility testing, stor- fication fails, performed under § 630.40 age and distribution of each unit of of this chapter. blood and blood components so that all (xi) Records of notification of the re- steps can be clearly traced. All records ferring physician of a deferred shall be legible and indelible, and shall autologous donor, including appro- identify the person performing the priate followup if the initial attempt work, include dates of the various en- at notification fails, performed under tries, show test results as well as the § 630.40 of this chapter. interpretation of the results, show the (2) Processing records: expiration date assigned to specific (i) Blood processing, including results products, and be as detailed as nec- and interpretation of all tests and essary to provide a complete history of retests. the work performed. (ii) Component preparation, includ- (2) Appropriate records shall be avail- ing all relevant dates and times. able from which to determine lot num- (iii) Separation and pooling of recov- bers of supplies and reagents used for ered plasma. specific lots or units of the final prod- (iv) Centrifugation and pooling of uct. source plasma. (b) Records shall be maintained that (v) Labeling, including initials of the include, but are not limited to, the fol- person(s) performing the procedure. lowing when applicable: (3) Storage and distribution records: (1) Donor records: (i) Distribution and disposition, as (i) Donor selection, including medical appropriate, of blood and blood prod- interview and examination and where ucts. applicable, informed consent. (ii) Visual inspection of whole blood (ii) Permanent and temporary defer- and red blood cells during storage and rals for health reasons including rea- immediately before distribution. son(s) for deferral. (iii) Storage temperature, including (iii) Donor adverse reaction com- initialed temperature recorder charts. plaints and reports, including results of (iv) Reissue, including records of all investigations and followup. proper temperature maintenance. (iv) Therapeutic bleedings, including (v) Emergency release of blood, in- signed requests from attending physi- cluding signature of requesting physi- cians, the donor’s disease and disposi- cian obtained before or after release. tion of units. (4) Compatibility test records: (v) Immunization, including informed (i) Results of all compatibility tests, consent, identification of the antigen, including crossmatching, testing of pa- dosage and route of administration. tient samples, antibody screening and (vi) Blood collection, including iden- identification. tification of the phlebotomist. (ii) Results of confirmatory testing. (vii) Records to relate the donor with (5) Quality control records: the unit number of each previous dona- (i) Calibration and standardization of tion from that donor. equipment. (viii) Records concerning the fol- (ii) Performance checks of equipment lowing activities performed under and reagents. §§ 610.46 and 610.47 of this chapter: Quar- (iii) Periodic check on sterile tech- antine; consignee notification; testing; nique.

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(iv) Periodic tests of capacity of ship- reactive under § 610.40(a)(1) of this ping containers to maintain proper chapter for evidence of infection due to temperature in transit. HIV, HBV, or HCV. In addition, estab- (v) Proficiency test results. lishments other than Source Plasma (6) Transfusion reaction reports and establishments must include in this cu- complaints, including records of inves- mulative record donors deferred from tigations and followup. donation under § 610.41 of this chapter (7) General records: because their donation tested reactive (i) Sterilization of supplies and re- under § 610.40(a)(2) of this chapter for agents prepared within the facility, in- evidence of infection due to HTLV or cluding date, time interval, tempera- Chagas disease. ture and mode. (3) The cumulative record described (ii) Responsible personnel. in paragraph (e)(2) of this section must (iii) Biological product deviations. be updated at least monthly to add do- (iv) Maintenance records for equip- nors newly deferred under § 610.41 of ment and general physical plant. this chapter due to reactive tests for (v) Supplies and reagents, including evidence of infection due to HIV, HBV, name of manufacturer or supplier, lot or HCV, and, if applicable, HTLV or numbers, expiration date and date of Chagas disease. receipt. (4) Establishments must revise the (vi) Disposition of rejected supplies cumulative record described in para- and reagents used in the collection, graph (e)(2) of this section to remove processing and compatibility testing of donors who have been requalified under blood and blood components. § 610.41(b) of this chapter. (c) A donor number shall be assigned to each accepted donor, which relates [40 FR 53532, Nov. 18, 1975, as amended at 61 the unit of blood collected to that FR 47422, Sept. 9, 1996; 64 FR 45371, Aug. 19, donor, to his medical record, to any 1999; 65 FR 66635, Nov. 7, 2000; 66 FR 31176, June 11, 2001; 72 FR 48798, Aug. 24, 2007; 80 FR component or from that 80651, Dec. 28, 2015; 80 FR 29895, May 22, 2015] donor’s unit of blood, and to all records describing the history and ultimate § 606.165 Distribution and receipt; pro- disposition of these products. cedures and records. (d) Records shall be retained for such (a) Distribution and receipt proce- interval beyond the expiration date for dures shall include a system by which the blood or blood component as nec- the distribution or receipt of each unit essary to facilitate the reporting of can be readily determined to facilitate any unfavorable clinical reactions. You its recall, if necessary. must retain individual product records no less than 10 years after the records (b) Distribution records shall contain of processing are completed or 6 information to readily facilitate the months after the latest expiration date identification of the name and address for the individual product, whichever is of the consignee, the date and quantity the later date. When there is no expira- delivered, the lot number of the unit(s), tion date, records shall be retained in- the date of expiration or the date of definitely. collection, whichever is applicable, or (e) Records of deferred donors. (1) Es- for crossmatched blood and blood com- tablishments must maintain at each ponents, the name of the recipient. location a record of all donors found to (c) Receipt records shall contain the be ineligible or deferred at that loca- name and address of the collecting fa- tion so that blood and blood compo- cility, date received, donor or lot num- nents from an ineligible donor are not ber assigned by the collecting facility collected and/or released while the and the date of expiration or the date donor is ineligible or deferred; and of collection, whichever is applicable. (2) Establishments must maintain at all locations operating under the same § 606.170 Adverse reaction file. license or under common management (a) Records shall be maintained of a cumulative record of donors deferred any reports of complaints of adverse from donation under § 610.41 of this reactions regarding each unit of blood chapter because their donation tested or blood product arising as a result of

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blood collection or transfusion. A thor- verse events concerning the affected ough investigation of each reported ad- product. verse reaction shall be made. A written (b) What do I report under this section? report of the investigation of adverse You must report any event, and infor- reactions, including conclusions and mation relevant to the event, associ- followup, shall be prepared and main- ated with the manufacturing, to in- tained as part of the record for that lot clude testing, processing, packing, la- or unit of final product by the col- beling, or storage, or with the holding lecting or transfusing facility. When it or distribution, of both licensed and is determined that the product was at unlicensed blood or blood components, fault in causing a transfusion reaction, including Source Plasma, if that event copies of all such written reports shall meets all the following criteria: be forwarded to and maintained by the (1) Either: manufacturer or collecting facility. (i) Represents a deviation from cur- (b) When a complication of blood col- rent good manufacturing practice, ap- lection or transfusion is confirmed to plicable regulations, applicable stand- be fatal, the Director, Office of Compli- ards, or established specifications that may affect the safety, purity, or po- ance and Biologics Quality, CBER, tency of that product; or must be notified by telephone, fac- (ii) Represents an unexpected or un- simile, express mail, or electronically foreseeable event that may affect the transmitted mail as soon as possible. A safety, purity, or potency of that prod- written report of the investigation uct; and must be submitted to the Director, Of- (2) Occurs in your facility or another fice of Compliance and Biologics Qual- facility under contract with you; and ity, CBER, by mail, facsimile, or elec- (3) Involves distributed blood or tronically transmitted mail (for mail- blood components. ing address, see § 600.2(a) of this chap- (c) When do I report under this section? ter), within 7 days after the fatality by You should report a biological product the collecting facility in the event of a deviation as soon as possible but you donor reaction, or by the facility that must report at a date not to exceed 45- performed the compatibility tests in calendar days from the date you, your the event of a transfusion reaction. agent, or another person who performs [40 FR 53532, Nov. 18, 1975, as amended at 49 a manufacturing, holding, or distribu- FR 23833, June 8, 1984; 50 FR 35471, Aug. 30, tion step under your control, acquire 1985; 55 FR 11014, Mar. 26, 1990; 64 FR 45371, information reasonably suggesting Aug. 19, 1999; 67 FR 9586, Mar. 4, 2002; 77 FR that a reportable event has occurred. 18, Jan. 3, 2012; 80 FR 18092, Apr. 3, 2015] (d) How do I report under this section? You must report on Form FDA–3486. § 606.171 Reporting of product devi- (e) Where do I report under this section? ations by licensed manufacturers, You must send the completed Form unlicensed registered blood estab- FDA 3486 to the Center for Biologics lishments, and transfusion services. Evaluation and Research (CBER), ei- (a) Who must report under this section? ther in paper or electronic format. You, a licensed manufacturer of blood (1) If you make a paper filing, send and blood components, including the completed form to the CBER Docu- Source Plasma; an unlicensed reg- ment Control Center (see mailing ad- istered blood establishment; or a trans- dress in § 600.2(a) of this chapter), and fusion service who had control over the identify on the envelope that a BPDR product when the deviation occurred, (biological product deviation report) is must report under this section. If you enclosed; or arrange for another person to perform (2) If you make an electronic filing, a manufacturing, holding, or distribu- send the completed Form FDA3486 elec- tion step, while the product is in your tronically using CBER’s electronic control, that step is performed under Web-based application. your control. You must establish, (f) How does this regulation affect other maintain, and follow a procedure for FDA regulations? This part supplements receiving information from that person and does not supersede other provisions on all deviations, complaints, and ad- of the regulations in this chapter. All

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biological product deviations, whether Subpart D—Exemptions or not they are required to be reported 607.65 Exemptions for blood product estab- under this section, should be inves- lishments. tigated in accordance with the applica- ble provisions of parts 211, 606, and 820 Subpart E—Establishment Registration and of this chapter. Product Listing Of Licensed Devices [65 FR 66635, Nov. 7, 2000, as amended at 70 607.80 Applicability of part 607 to licensed FR 14984, Mar. 24, 2005; 80 FR 18092, Apr. 3, devices. 2015] AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 355, 360, 371, 374, 381, 393; 42 U.S.C. 262, 264, 271.

PART 607—ESTABLISHMENT REG- SOURCE: 40 FR 52788, Nov. 12, 1975, unless ISTRATION AND PRODUCT LIST- otherwise noted. ING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD Subpart A—General Provisions PRODUCTS AND LICENSED DE- VICES § 607.1 Scope. (a) This part establishes establish- Subpart A—General Provisions ment registration and product listing requirements for manufacturers of Sec. human blood and blood products. 607.1 Scope. (b) This part establishes establish- 607.3 Definitions. ment registration and product listing 607.7 Establishment registration and prod- requirements for manufacturers of uct listing of blood banks and other products that meet the definition of a firms manufacturing human blood and device under the Federal Food, Drug, blood products. and Cosmetic Act and that are licensed under section 351 of the Public Health Subpart B—Procedures for Domestic Blood Service Act, as well as licensed biologi- Product Establishments cal products used in the manufacture 607.20 Who must register and submit a blood of a licensed device. product list. [81 FR 60221, Aug. 31, 2016] 607.21 Times for establishment registration and blood product listing. § 607.3 Definitions. 607.22 How to register establishments and (a) The term act means the Federal list blood products. Food, Drug, and Cosmetic Act approved 607.25 Information required for establish- ment registration and blood product list- June 25, 1938 (52 Stat. 1040 et seq., as ing. amended, 21 U.S.C. 301–392). 607.26 Amendments to establishment reg- (b) Blood and blood product means a istration. drug which consists of human whole 607.30 Updating blood product listing infor- blood, plasma, or serum or any product mation. derived from human whole blood, plas- 607.31 Additional blood product listing in- ma, or serum, hereinafter referred to as formation. ‘‘blood product.’’ For the purposes of 607.35 Blood product establishment registra- this part only, blood and blood product tion number. also means those products that meet 607.37 Public disclosure of establishment the definition of a device under the registration and blood product listing in- Federal Food, Drug, and Cosmetic Act formation. and that are licensed under section 351 607.39 Misbranding by reference to estab- of the Public Health Service Act, as lishment registration, validation of reg- well as licensed biological products istration, or to registration number. used in the manufacture of a licensed device. Subpart C—Procedures for Foreign Blood (c) Establishment means a place of Product Establishments business under one management at one 607.40 Establishment registration and blood general physical location. The term in- product listing requirements for foreign cludes, among others, human blood and blood product establishments. plasma donor centers, blood banks,

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