0458 21cfr606 171 2-2007

§ 606.165

21 CFR Ch. I (4–1–06 Edition)

(i) Sterilization of supplies and reagents prepared within the facility, including date, time interval, temperature and mode.
(ii) Responsible personnel.
(iii) Biological product deviations.
(iv) Maintenance records for equipment and general physical plant.
(v) Supplies and reagents, including
name of manufacturer or supplier, lot
numbers, expiration date and date of
receipt.
(vi) Disposition of rejected supplies
and reagents used in the collection,
processing and compatibility testing of
blood and blood components.
(c) A donor number shall be assigned
to each accepted donor, which relates
the unit of blood collected to that
donor, to his medical record, to any
component or blood product from that
donor’s unit of blood, and to all records
describing the history and ultimate
disposition of these products.
(d) Records shall be retained for such
interval beyond the expiration date for
the blood or blood component as necessary to facilitate the reporting of
any unfavorable clinical reactions. The
retention period shall be no less than 5
years after the records of processing
have been completed or 6 months after
the latest expiration date for the individual product, whichever is a later
date. When there is no expiration date,
records shall be retained indefinitely.
(e) A record shall be available from
which unsuitable donors may be identified so that products from such individuals will not be distributed.

for crossmatched blood and blood components, the name of the recipient.
(c) Receipt records shall contain the
name and address of the collecting facility, date received, donor or lot number assigned by the collecting facility
and the date of expiration or the date
of collection, whichever is applicable.
§ 606.170

Adverse reaction file.

(a) Records shall be maintained of
any reports of complaints of adverse
reactions regarding each unit of blood
or blood product arising as a result of
blood collection or transfusion. A thorough investigation of each reported adverse reaction shall be made. A written
report of the investigation of adverse
reactions, including conclusions and
followup, shall be prepared and maintained as part of the record for that lot
or unit of final product by the collecting or transfusing facility. When it
is determined that the product was at
fault in causing a transfusion reaction,
copies of all such written reports shall
be forwarded to and maintained by the
manufacturer or collecting facility.
(b) When a complication of blood collection or transfusion is confirmed to
be fatal, the Director, Office of Compliance and Biologics Quality, Center for
Biologics Evaluation and Research,
shall be notified by telephone, facsimile, express mail, or electronically
transmitted mail as soon as possible; a
written report of the investigation
shall be submitted to the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation
and Research, within 7 days after the
fatality by the collecting facility in
the event of a donor reaction, or by the
facility that performed the compatibility tests in the event of a transfusion reaction.

[40 FR 53532, Nov. 18, 1975, as amended at 61
FR 47422, Sept. 9, 1996; 64 FR 45371, Aug. 19,
1999; 65 FR 66635, Nov. 7, 2000; 66 FR 31176,
June 11, 2001]

§ 606.165 Distribution and receipt; procedures and records.
(a) Distribution and receipt procedures shall include a system by which
the distribution or receipt of each unit
can be readily determined to facilitate
its recall, if necessary.
(b) Distribution records shall contain
information to readily facilitate the
identification of the name and address
of the consignee, the date and quantity
delivered, the lot number of the unit(s),
the date of expiration or the date of
collection, whichever is applicable, or

[40 FR 53532, Nov. 18, 1975, as amended at 49
FR 23833, June 8, 1984; 50 FR 35471, Aug. 30,
1985; 55 FR 11014, Mar. 26, 1990; 64 FR 45371,
Aug. 19, 1999; 67 FR 9586, Mar. 4, 2002]

§ 606.171 Reporting of product deviations by licensed manufacturers,
unlicensed registered blood establishments, and transfusion services.
(a) Who must report under this section?
You, a licensed manufacturer of blood
and
blood
components,
including

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Food and Drug Administration, HHS

Pt. 607

Source Plasma; an unlicensed registered blood establishment; or a transfusion service who had control over the
product when the deviation occurred,
must report under this section. If you
arrange for another person to perform
a manufacturing, holding, or distribution step, while the product is in your
control, that step is performed under
your control. You must establish,
maintain, and follow a procedure for
receiving information from that person
on all deviations, complaints, and adverse events concerning the affected
product.
(b) What do I report under this section?
You must report any event, and information relevant to the event, associated with the manufacturing, to include testing, processing, packing, labeling, or storage, or with the holding
or distribution, of both licensed and
unlicensed blood or blood components,
including Source Plasma, if that event
meets all the following criteria:
(1) Either:
(i) Represents a deviation from current good manufacturing practice, applicable regulations, applicable standards, or established specifications that
may affect the safety, purity, or potency of that product; or
(ii) Represents an unexpected or unforeseeable event that may affect the
safety, purity, or potency of that product; and
(2) Occurs in your facility or another
facility under contract with you; and
(3) Involves distributed blood or
blood components.
(c) When do I report under this section?
You should report a biological product
deviation as soon as possible but you
must report at a date not to exceed 45calendar days from the date you, your
agent, or another person who performs
a manufacturing, holding, or distribution step under your control, acquire
information
reasonably
suggesting
that a reportable event has occurred.
(d) How do I report under this section?
You must report on Form FDA–3486.
(e) Where do I report under this section?
You must send the completed Form
FDA–3486 to the Director, Office of
Compliance and Biologics Quality
(HFM–600) (see mailing addresses in
§ 600.2 of this chapter) by either a paper
or electronic filing:

(1) If you make a paper filing, you
should identify on the envelope that a
BPDR (biological product deviation report) is enclosed; or
(2) If you make an electronic filing,
you may submit the completed Form
FDA–3486
electronically
through
CBER’s website at www.fda.gov/cber.
(f) How does this regulation affect other
FDA regulations? This part supplements
and does not supersede other provisions
of the regulations in this chapter. All
biological product deviations, whether
or not they are required to be reported
under this section, should be investigated in accordance with the applicable provisions of parts 211, 606, and 820
of this chapter.
[65 FR 66635, Nov. 7, 2000, as amended at 70
FR 14984, Mar. 24, 2005]

PART 607—ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF
HUMAN BLOOD AND BLOOD
PRODUCTS
Subpart A—General Provisions
Sec.
607.3 Definitions.
607.7 Establishment registration and product listing of blood banks and other
firms manufacturing human blood and
blood products.

Subpart B—Procedures for Domestic Blood
Product Establishments
607.20 Who must register and submit a blood
product list.
607.21 Times for establishment registration
and blood product listing.
607.22 How and where to register establishments and list blood products.
607.25 Information required for establishment registration and blood product listing.
607.26 Amendments to establishment registration.
607.30 Updating blood product listing information.
607.31 Additional blood product listing information.
607.35 Notification of registrant; blood product establishment registration number
and NDC Labeler Code.
607.37 Inspection of establishment registrations and blood product listings.
607.39 Misbranding by reference to establishment registration or to registration
number.

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