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to be ineligible or for whom a donor of the various entries, and must be as eligibility determination has not been detailed as necessary to provide a comcompleted (except as provided under plete history of the work performed $$ 1271.60, 1271.65, and 1271.90), or that and to relate the records to the parotherwise does not meet release cri- ticular HCT/P involved. teria designed to prevent commu (b) Records management system. You nicable disease transmission.

must establish and maintain a records (3) You must not make available for management system relating to core distribution any HCT/P manufactured CGTP requirements. Under this sysunder a departure from a procedure rel tem, records pertaining to a particular evant to preventing risks of commu- HCT/P must be maintained in such a nicable disease transmission, unless a way as to facilitate review of the HCT/ responsible person has determined that Ps history before making it available the departure does not increase the for distribution and, if necessary, subrisk of communicable disease through sequent to the HCT/Ps release as part the use of the HCT/P. You must record of a followup evaluation or investigaand justify any departure from a proce- tion. Records pertinent to the manudure at the time of its occurrence.

facture of HCT/Ps (e.g., labeling and (d) Packaging and shipping. Packaging packaging procedures, and equipment and shipping containers must be de- logs) must also be maintained and orsigned and constructed to protect the ganized under the records management HCT/P from contamination. For each system. If records are maintained in type of HCT/P, you must establish ap- more than one location, then the propriate shipping conditions to be records management system must be maintained during transit.

designed to ensure prompt identifica(e) Procedures. You must establish tion, location, and retrieval of all and maintain procedures, including re- records. lease criteria, for the activities in (c) Methods of retention. You may paragraphs (a) through (d) of this sec- maintain records required under this tion. You must document these activi- subpart electronically, as origi ties. Documentation must include:

paper records, or as true copies such as (1) Identification of the HCT/P and photocopies, microfiche, or microfilm. the establishment that supplied the Equipment that is necessary to make НСТР;

the records available and legible, such (2) Activities performed and the re as computer and reader equipment, sults of each activity;

must be readily available. Records (3) Date(s) of activity;

stored in electronic systems must be (4) Quantity of HCT/P subject to the backed up. activity; and

(d) Length of retention. You must re(5) Disposition of the HCT/P (e.g., tain all records for 10 years after their identity of consignee).

creation, unless stated otherwise in (f) Return to inventory. You must es this part. However, you must retain tablish and maintain procedures to de the records pertaining to a particular termine if an HCT/P that is returned to HCT/P at least 10 years after the date your establishment is suitable to be re of its administration, or if the date of turned to inventory.

administration is not known, then at

least 10 years after the date of the $ 1271.270 Records.

HCT/Ps distribution, disposition, or ex(a) General. You must maintain piration, whichever is latest. You must records concurrently with the perform- retain records for archived specimens ance of each step required in this sub- of dura mater for 10 years after the appart and subpart C of this part. Any re- propriate disposition of the specimens. quirement in this part that an action (e) Contracts and agreements. You be documented involves the creation of must maintain the name and address a record, which is subject to the re- and a list of the responsibilities of any quirements of this section. All records establishment that performs a manumust be accurate, indelible, and leg facturing step for you. This informaible. The records must identify the per- tion must be available during an inson performing the work and the dates spection conducted under $1271.400.

$ 1271.290 Tracking.

tion code and type of each HCT/P dis(a) General. If you perform any step

tributed to a consignee to enable

tracking from the consignee to the in the manufacture of an HCT/P in which you handle the HCT/P, you must

donor. track each such HCT/P in accordance

(e) Tracking from donor to consignee or

final disposition. As part of your trackwith this section, to facilitate the investigation of actual or suspected

ing system, you must establish and transmission of communicable disease

maintain a method for documenting

the disposition of each of your HCT/Ps, and take appropriate and timely cor

to enable tracking from the donor to rective action. (b) System of HCT/P tracking. (1) You

the consignee or final disposition. The must establish and maintain a system

information you maintain must permit of HCT/P tracking that enables the

the prompt identification of the contracking of all HCT/Ps from:

signee of the HCT/P, if any.

(f) Consignees. At or before the time (i) The donor to the consignee or

of distribution of an HCT/P to a confinal disposition; and (ii) The consignee or final disposition

signee, you must inform the consignee to the donor.

in writing of the requirements in this

section and of the tracking system (2) Alternatively, if you are an establishment that performs some but not

that you have established and are all of the steps in the manufacture of

maintaining to comply with these rean HCT/P in which you handle the HCT/

quirements. P, you may participate in a system of

(g) Requirements specific to dura mater HCT/P tracking established and main

donors. You must archive appropriate tained by another establishment re

specimens from each donor of dura sponsible for other steps in the manu

mater, under appropriate storage confacture of the same HCT/P, provided

ditions, and for the appropriate durathat the tracking system complies

tion, to enable testing of the archived with all the requirements of this sec

material for evidence of transmissible tion.

spongiform encephalopathy, and to en(c) Distinct identification code. As part

able appropriate disposition of any afof your tracking system, you must en

fected nonadministered dura mater tissure: That each HCT/P that you manu

sue, if necessary. facture is assigned and labeled with a [69 FR 68681, Nov. 24, 2004, as amended at 70 distinct identification code, e.g., alpha- FR 29952, May 25, 2005] numeric, that relates the HCT/P to the donor and to all records pertaining to 81271.320 Complaint file. the HCT/P; and that labeling includes (a) Procedures. You must establish information designed to facilitate ef and maintain procedures for the refective tracking, using the distinct view, evaluation, and documentation of identification code, from the donor to complaints as defined in $1271.3(aa), 1€ the recipient and from the recipient tolating to core current good tissue practhe donor. Except as described in tice (CGTP) requirements, and the in$1271.55(a)(1), you must create such a vestigation of complaints as approcode specifically for tracking, and it priate. may not include an individual's name, (b) Complaint file. You must maintain social security number, or medical a record of complaints that you receive record number. You may adopt a dis in a file designated for complaints. The tinct identification code assigned by complaint file must contain sufficient another establishment engaged in the information about each complaint for manufacturing process, or you may as- proper review and evaluation of the sign a new code. If you assign a new complaint (including the distinct idencode to an HCT/P, you must establish tification code of the HCT/P that is the and maintain procedures for relating subject of the complaint) and for deterthe new code to the old code.

mining whether the complaint is an (d) Tracking from consignee to donor. isolated event or represents a trend. As part of your tracking system, you You must make the complaint file must establish and maintain a method available for review and copying upon for recording the distinct identifica request from FDA.

:) Review and evaluation of comnts. You must review and evaluate h complaint relating to core CGTP uirements to determine if the comInt is related to an HCT/P deviation o an adverse reaction, and to deterle if a report under $1271.350 or aner applicable regulation is required. soon as practical, you must review, luate, and investigate each comint that represents an event rered to be reported to FDA, as deibed in $1271.350. You must review Tevaluate a complaint relating to e CGTP requirements that does not resent an event required to be re'ted to determine whether an invesation is necessary; an investigation y include referring a copy of the nplaint to another establishment at performed manufacturing steps rtinent to the complaint. When no vestigation is made, you must mainin a record that includes the reason

investigation was made, and the me of the individual(s) responsible the decision not to investigate.

bpart E-Additional Requirements for Establishments Described in § 1271.10

to FDA an adverse reaction involving a communicable disease if it:

(i) Is fatal;
(ii) Is life-threatening;

(iii) Results in permanent impairment of a body function or permanent damage to body structure; or

(iv) Necessitates medical or surgical intervention, including hospitalization.

(2) You must submit each report on a Form FDA-3500A to the address in paragraph (a)(5) of this section within 15 calendar days of initial receipt of the information.

(3) You must, as soon as practical, investigate all adverse reactions that are the subject of these 15-day reports and must submit followup reports within 15 calendar days of the receipt of new information or as requested by FDA. If additional information is not obtainable, a followup report may be required that describes briefly the steps taken to seek additional information and the reasons why it could not be obtained.

(4) You may obtain copies of the reporting form (FDA-3500A) from the Center for Biologics Evaluation and Research (see address in paragraph (a)(5) of this section). Electronic Form FDA-3500A may be obtained at http:// www.fda.gov/medwatch or at http:// www.hhs.gov/forms.

(5) You must submit two copies of each report described in this paragraph to the Center for Biologics Evaluation and Research (HFM-210), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852– 1448. FDA may waive the requirement for the second copy in appropriate circumstances.

(b) Reports of HCT/P deviations. (1) You must investigate all HCT/P deviations related to a distributed HCT/P for which you performed a manufacturing step.

(2) You must report any such HCT/P deviation relating to the core CGTP requirements, if the HCT/P deviation occurred in your facility or in a facility that performed a manufacturing step for you under contract, agreement, or other arrangement. Each report must contain a description of the HCT/P deviation, information relevant to the event and the manufacture of the HCT/ P involved, and information on all follow-up actions that have been or will

SOURCE: 69 FR 68686, Nov. 24, 2004, unless herwise noted.

271.330 Applicability. The provisions set forth in this subirt are being implemented for nonproductive HCT/Ps described in 271.10 and regulated solely under secon 361 of the Public Health Service it and the regulations in this part, d for the establishments that manucture those HCT/Ps. HCT/Ps that are ugs or devices regulated under the t, or are biological products reguted under section 351 of the Public alth Service Act, are not subject to e regulations set forth in this subirt.

271.350 Reporting. (a) Adverse reaction reports. (1) You ust investigate any adverse reaction volving a communicable disease reted to an HCT/P that you made avail. ble for distribution. You must report

be taken in response to the HCT/P devi- Subpart F-Inspection and Enation (e.g., recalls).

forcement of Establishments (3) You must report each such HCT/P.

Described in § 1271.10 deviation that relates to a core CGTP requirement on Form FDA-3486 avail

SOURCE: 69 FR 68687, Nov. 24, 2004, unless able at http://www.fda.gov/cber/biodev/ bpdrform.pdf, within 45 days of the dis

otherwise noted. covery of the event either electroni

$ 1271.390 Applicability. cally at http://www.fda.gov/cber/biodev/ biodevsub.htm or by mail to the Direc

The provisions set forth in this subtor, Office of Compliance and Biologics

part are applicable only to HCT/Ps deQuality, Center for Biologics Evalua

scribed in $1271.10 and regulated solely

under section 361 of the Public Health tion and Research (HFM-600), 1401 Rockville Pike, suite 200N, Rockville,

Service Act and the regulations in this MD 20852–1448.

part, and to the establishments that

manufacture those HCT/Ps. HCT Ps $ 1271.370 Labeling.

that are drugs or devices regulated

under the act, or are biological prodThe following requirements apply in

ucts regulated under section 351 of the addition to $$ 1271.55, 1271.60, 1271.65,

Public Health Service Act, are not suband 1271.90:

ject to the regulations set forth in this (a) You must label each HCT/P made

subpart. available for distribution clearly and accurately.

$ 1271.400 Inspections. (b) The following information must

(a) If you are an establishment that appear on the HCT/P label:

manufactures HCT/Ps described in (1) Distinct identification code af

$1271.10, whether or not under contract, fixed to the HCT/P container, and as

you must permit the Food and Drug signed in accordance with $1271.290(c);

Administration (FDA) to inspect any (2) Description of the type of HCT/P;

manufacturing location at any reason(3) Expiration date, if any; and

able time and in a reasonable manner (4) Warnings required under to determine compliance with applica$ 1271.60(d)(2), 81271.65(b)(2), or

ble provisions of this part. The inspec$ 1271.90(b), if applicable and physically tion will be conducted as necessary in possible. If it is not physically possible the judgment of the FDA and may into include these warnings on the label, clude your establishment, facilities, the warnings must, instead, accompany equipment, finished and unfinished mathe HCT/P.

terials, containers, processes, HCT Ps. (c) The following information must procedures, labeling, records, files, pseither appear on the HCT/P label or ac pers, and controls required to be maincompany the HCT/P:

tained under the part. The inspection (1) Name and address of the establish- may be made with or without prior noment that determines that the HCT/P tification and will ordinarily be made meets release criteria and makes the during regular business hours. HCT/P available for distribution;

(b) The frequency of inspection will (2) Storage temperature;

be at the agency's discretion. (3) Other warnings, where appro- (c) FDA will call upon the most repriate; and

sponsible person available at the time (4) Instructions for use when related of the inspection of the establishment to the prevention of the introduction, and may question the personnel of the transmission, or spread of commu establishment as necessary to deternicable diseases.

mine compliance with the provisions of

this part. [69 FR 68686, Nov. 24, 2004, as amended at 70

(d) FDA's representatives may take FR 29952, May 25, 2005]

samples, may review and copy any records required to be kept under this part, and may use other appropriate

disease transmission which indicates the need to review the information referenced in paragraph (a) of this section.

neans to record evidence of observaions during inspections conducted under this subpart.

(e) The public disclosure of records ontaining the name or other positive dentification of donors or recipients of ICT/Ps will be handled in accordance vith FDA's procedures on disclosure of nformation as set forth in parts 20 and 1 of this chapter. 1271.420 HCT/Ps offered for import.

(a) Except as provided in paragraphs C) and (d) of this section, when an ICT/P is offered for import, the imsorter of record must notify, either beore or at the time of importation, the lirector of the district of the Food and Drug Administration (FDA) having jurisdiction over the port of entry through which the HCT/P is imported or offered for import, or such officer of the district as the director may designate to act in his or her behalf in administering and enforcing this part, and must provide sufficient information for FDA to make an admissibility iecision.

(b) Except as provided in paragraphs c) and (d) of this section, an HCT/P offered for import must be held intact by che importer or consignee, under conditions necessary to prevent transmission of communicable disease, until an admissibility decision is made by FDA. The HCT/P may be transported under quarantine to the consignee, while the FDA district reviews the documentation accompanying the HCT/P. When FDA makes a decision regarding the admissibility of the HCT/P, FDA will notify the importer of record.

(C) This section does not apply to reproductive HCT/Ps regulated solely inder section 361 of the Public Health Service Act and the regulations in this part, and donated by a sexually intinate partner of the recipient for reproluctive use.

(d) This section does not apply to peipheral blood stem/progenitor cells regulated solely under section 361 of

he Public Health Service Act and the regulations in this part, except that paragraphs (a) and (b) of this section upply when circumstances occur under which such imported peripheral blood stem/progenitor cells may present an inreasonable risk of communicable

$1271.440 Orders of retention, recall,

destruction, and cessation of manu

facturing. (a) Upon an agency finding that there are reasonable grounds to believe that an HCT/P is a violative HCT/P because it was manufactured in violation of the regulations in this part and, therefore, the conditions of manufacture of the HCT/P do not provide adequate protections against risks of communicable disease transmission; or the HCT/P is infected or contaminated so as to be a source of dangerous infection to humans; or an establishment is in violation of the regulations in this part and, therefore, does not provide adequate protections against the risks of communicable disease transmission, the Food and Drug Administration (FDA) may take one or more of the following actions:

(1) Serve upon the person who distributed the HCT/P a written order that the HCT/P be recalled and/or destroyed, as appropriate, and upon persons in possession of the HCT/P that the HCT/P must be retained until it is recalled by the distributor, destroyed, or disposed of as agreed by FDA, or the safety of the HCT/P is confirmed;

(2) Take possession of and/or destroy the violative HCT/P; or

(3) Serve upon the establishment an order to cease manufacturing until compliance with the regulations of this part has been achieved. When FDA determines there are reasonable grounds to believe there is a danger to health, such order will be effective immediately. In other situations, such order will be effective after one of the following events, whichever is later:

(i) Passage of 5 working days from the establishment's receipt of the order; or

(ii) If the establishment requests a hearing in accordance with paragraph (e) of this section and part 16 of this chapter, a decision in, and in accordance with, those proceedings.

(b) A written order issued under paragraph (a) of this section will state with

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