0338 21cfr606 110 2007

Food and Drug Administration, HHS

§ 606.110

(15) Schedules and procedures for
equipment maintenance and calibration.
(16) Labeling procedures, including
safeguards to avoid labeling mixups.
(17) Procedures of plasmapheresis,
plateletpheresis, and leukapheresis, if
performed, including precautions to be
taken to ensure reinfusion of a donor’s
own cells.
(18) Procedures for preparing recovered plasma, if performed, including
details of separation, pooling, labeling,
storage, and distribution.
(19) Procedures in accordance with
§ 610.46 of this chapter to look at prior
donations of Whole Blood, blood components, Source Plasma and Source
Leukocytes from a donor who has donated blood and subsequently tests repeatedly reactive for antibody to
human immunodeficiency virus (HIV)
or otherwise is determined to be unsuitable when tested in accordance
with § 610.45 of this chapter. Procedures
to quarantine in-house Whole Blood,
blood components, Source Plasma and
Source Leukocytes intended for further
manufacture into injectable products
that were obtained from such donors;
procedures to notify consignees regarding the need to quarantine such products; procedures to determine the suitability for release of such products
from quarantine; procedures to notify
consignees of Whole Blood, blood components, Source Plasma and Source
Leukocytes from such donors of the results of the antibody testing of such
donors; and procedures in accordance
with § 610.47 of this chapter to notify
attending physicians so that transfusion recipients are informed that
they may have received Whole Blood
and, blood components at increased
risk for transmitting human immunodeficiency virus.
(20) Procedures for donor deferral as
prescribed in § 610.41 of this chapter;
and procedures for donor notification
and autologous donor referring physician notification, including procedures
for the appropriate followup if the initial attempt at notification fails, as
prescribed in § 630.6 of this chapter.
(c) All records pertinent to the lot or
unit maintained pursuant to these regulations shall be reviewed before the
release or distribution of a lot or unit

of final product. The review or portions
of the review may be performed at appropriate periods during or after blood
collecting, processing, compatibility
testing and storing. A thorough investigation, including the conclusions and
followup, of any unexplained discrepancy or the failure of a lot or unit to
meet any of its specifications shall be
made and recorded.
(d) In addition to the requirements of
this subpart and in conformity with
this section, any facility may utilize
current standard operating procedures
such as the manuals of the organizations, as long as such specific procedures are consistent with, and at least
as stringent as, the requirements contained in this part.
(1) American Association of Blood
Banks.
(2) American National Red Cross.
(3) Other organizations or individual
blood banks, subject to approval by the
Director, Center for Biologics Evaluation and Research.
[40 FR 53532, Nov. 18, 1975, as amended at 49
FR 23833, June 8, 1984; 55 FR 11013, Mar. 26,
1990; 61 FR 47422, Sept. 9, 1996; 64 FR 45370,
Aug. 19, 1999; 66 FR 31176, June 11, 2001]

§ 606.110 Plateletpheresis,
leukapheresis, and plasmapheresis.
(a) The use of plateletpheresis and
leukapheresis procedures to obtain a
product for a specific recipient may be
at variance with the additional standards for specific products prescribed in
this part provided that: (1) A physician
has determined that the recipient must
be transfused with the leukocytes or
platelets from a specific donor, and (2)
the procedure is performed under the
supervision of a qualified licensed physician who is aware of the health status of the donor, and the physician has
certified in writing that the donor’s
health permits plateletpheresis or
leukapheresis.
(b) Plasmapheresis of donors who do
not meet the donor requirements of
§§ 640.63, 640.64 and 640.65 of this chapter
for the collection of plasma containing
rare antibodies shall be permitted only
with the prior approval of the Director,

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§ 606.120

21 CFR Ch. I (4–1–05 Edition)

Center for Biologics Evaluation and
Research.

(2) The name, address, registration
number, and, if a licensed product, the
license number of each manufacturer.
(3) The donor, pool, or lot number relating the unit to the donor.
(4) The expiration date, including the
day, month, and year, and, if the dating period for the product is 72 hours or
less, the hour of expiration.
(5) If the product is intended for
transfusion, the appropriate donor
classification statement, i.e., ‘‘paid
donor’’ or ‘‘volunteer donor’’, in no less
prominence than the proper name of
the product.
(i) A paid donor is a person who receives monetary payment for a blood
donation.
(ii) A volunteer donor is a person who
does not receive monetary payment for
a blood donation.
(iii) Benefits, such as time off from
work, membership in blood assurance
programs, and cancellation of nonreplacement fees that are not readily
convertible to cash, do not constitute
monetary payment within the meaning
of this paragraph.
(6) For Whole Blood, Plasma, Platelets, and partial units of Red Blood
Cells, the volume of the product, accurate to within ±10 percent; or optionally for Platelets, the volume range
within reasonable limits.
(7) The recommended storage temperature (in degrees Celsius).
(8) If the product is intended for
transfusion, the statements:
(i) ‘‘Rx only.’’
(ii) ‘‘See circular of information for
indications, contraindications, cautions, and methods of infusion.’’
(iii) ‘‘Properly identify intended recipient.’’
(9) The statement: ‘‘This product
may transmit infectious agents.’’
(10) Where applicable, the name and
volume of source material.
(11) The statement: ‘‘Caution: For
Manufacturing Use Only’’, when applicable.
(12) If the product is intended for
transfusion, the ABO and Rh groups of
the donor shall be designated conspicuously. For Cryoprecipitated AHF, the
Rh group may be omitted. The Rh
group shall be designated as follows:

[40 FR 53532, Nov. 18, 1975, as amended at 49
FR 23833, June 8, 1984; 55 FR 11013, Mar. 26,
1990]

Subpart G—Finished Product
Control
§ 606.120 Labeling, general requirements.
(a) Labeling operations shall be separated physically or spatially from
other operations in a manner adequate
to prevent mixups.
(b) The labeling operation shall include the following labeling controls:
(1) Labels shall be held upon receipt,
pending review and proofing against an
approved final copy, to ensure accuracy
regarding identity, content, and conformity with the approved copy.
(2) Each type of label representing
different products shall be stored and
maintained in a manner to prevent
mixups, and stocks of obsolete labels
shall be destroyed.
(3) All necessary checks in labeling
procedures shall be utilized to prevent
errors in translating test results to
container labels.
(c) All labeling shall be clear and legible.
[50 FR 35469, Aug. 30, 1985]

§ 606.121 Container label.
(a) The container label requirements
are designed to facilitate the use of a
uniform container label for blood and
blood components (except Source Plasma) by all blood establishments.
(b) The label provided by the collecting facility and the initial processing facility shall not be removed, altered, or obscured, except that the
label may be altered to indicate the
proper name and other information required to identify accurately the contents of a container after blood components have been prepared.
(c) The container label shall include
the following information, as well as
other specialized information as required in this section for specific products:
(1) The proper name of the product in
a prominent position, and modifier(s),
if appropriate.

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