Frequently Asked Questions
Bar Code Label Requirements
for Blood and Blood Components
Is it true that we must label blood and blood
components with specific machine-readable bar code information
by April 26th, 2006?
- Yes, under the bar code label requirements final rule of
Feb 26, 2004, products subject to the rule, including blood
and blood components intended for transfusion, must be in
compliance by April 26, 2006. The regulation for blood and
blood components is located at 21 CFR 606.121(c)(13). The
final rule is entitled: Bar Code Label Requirement for Human
Drug Products and Biological Products (69 Federal Register
9120, February 26, 2004).
What machine-readable information is required for
blood and blood components?
- 21 CFR 606.121(c)(13)(ii-iii) states the container label
must bear encoded information in a format that is
machine-readable and approved for use by the Director,
Center for Biologics Evaluation and Research.
- Currently, two types of machine-readable label types are
recognized by FDA: FDA recognized the use of Codabar (a
specific bar code symbology) in 1985; and FDA accepted the
use of ISBT 128, version 1.2.0, in 2000.
- Each label must have at a minimum: (A) A unique facility
identifier; (B) Lot number relating to the donor; (C)
Product code; and, (D) ABO and Rh of the donor.
We are a transfusion service and very infrequently
prepare split units, pediatric units, and pooled
cryoprecipitate units; do we need machine-readable labels for
these units?
- Yes, This situation was described in the preamble to the
proposed rule (68 Federal Register 12500 at 12513):
"The unit of blood or blood component label would
contain the machine-readable information if the blood or
blood component has any possibility of being transfused to
a patient, whether or not the unit is actually transfused.
Additionally, the phrase, "from which the blood or blood
component can be taken and transfused to a patient" would
include the circumstance where blood or a blood component
is extracted or aspirated with a syringe from the
container of blood or blood component in order to
transfuse to a patient. This technique might be used when
transfusing neonates or under other medically necessitated
circumstances. In this case, the blood or blood component
from which the aspirate is taken must have affixed to it a
label containing the required machine-readable
information. This would be consistent with the
pre-existing requirement at § 606.121(c)(8)(iii) that
requires specific statements if a product is intended for
transfusion."
I have questions about how to encode facility
identifiers and product codes for pooled and aliquoted units
for Codabar or ISBT 128? Where do I get information about
these issues?
- Please contact CBER’s Manufacturers Assistance and
Technical Training Branch (MATTB) at matt@cber.fda.gov for
additional information. The regulation requires a unique
facility identifier.
How will FDA evaluate compliance with the
rule?
- Our investigators will evaluate compliance with these
regulations during routine inspections of blood
establishments.
May I request an exception or alternative under 21
CFR 640.120 for this requirement of the blood and blood
component container label regulations?
- The purpose of the bar coding rule is to reduce
transfusion errors and increase patient safety. CBER will
carefully review any request for exception or alternative.
The bar code regulation for drug products recognizes that
exemptions may be warranted when compliance would adversely
affect the drug’s safety, effectiveness, purity or potency
or not be technologically feasible. In the preamble to the
rule discussing exemptions for drug products, FDA noted that
almost all drug products are capable of bearing a bar code.
FDA noted that we would not consider written requests based
on reasons such as financial reasons, a claimed low rate of
medication errors, or a claim that the product is unique
such that medication errors do not occur or rarely occur. In
assessing requests for exemptions for blood and blood
components, FDA would follow the same approach as that
described in the drug regulations (21 CFR 201.25(d)).
Bar
Code Label Requirement for Human Drug Products and Biological
Products; Final rule; correction
Bar
Code Requirements for Blood Banks
Guidance for
Industry: Bar Code Label Requirements - Questions and
Answers
Guideline
for the Uniform Labeling of Blood and Blood Components
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