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Bar Code Label Requirements for Blood and Blood Components

Judy Ellen Ciaraldi
BS, MT(ASCP)SBB, CQA(ASQ)
Consumer Safety Officer, DBA, OBRR, CBER
ACBSA, May 9-10, 2006

Before the Bar Code Rule

Old regulation (21 CFR 606.121(c)(13)):

Container label may bear encoded information in the form of machine readable symbols approved for use the Director, CBER

Why Require Bar Codes?

  • DHHS Secretary Thompson set up a Patient Safety Task Force in 2001
  • Bar codes allow healthcare professionals to use scanning equipment to verify right drug (blood component) is given to right patient
  • Reduce number of medicine and transfusion errors (502,000 in 20 years)
  • Save healthcare costs ($93 billion in 20 years)

Bar Code Label Rule

  • Now mandates machine readable information on label
  • Final Rule - February 26, 2004 (69 FR 9120)
  • Effective date - April 26, 2004
  • Dates for compliance:
    • Products approved after effective date - within 60 days of approval
    • Products approved before effective date - within 2 years of effective date (April 26, 2006), includes blood components

Applicable Regulations

  • 21 CFR 201.25 - Bar code label requirements
    • Applies to most prescription drugs and certain OTC drugs regulated under FD&C and PHS Acts
    • Minimum information in linear bar code - NDC number
    • Does not apply to hospitals, clinics or public health agencies
  • 21 CFR 610.17 - Bar code label requirements
    • Biological products must comply with 201.25
    • Does not apply to devices
    • Does not apply to blood and blood components for transfusion; these must comply with 606.121(c)(13)

Applicable Regulations

  • 21 CFR 606.121(c)(13) - Container label
    • Container label must bear encoded information in format that is machine readable and approved by Director, CBER
    • Applies to blood and blood components intended for transfusion regulated under FD&C and PHS Acts
    • Applies to all blood establishments that manufacture, process, repack or relabel blood and blood components, including hospital transfusion services that pool or aliquot blood components
    • Does not apply to Source Plasma

Which Products Must Comply?

  • Any blood component that can be transfused to a patient and blood components used to make the final transfusible blood component. Also includes:
    • Aliquots
    • Split or divided units
    • Syringes
    • Pooled units
  • Intraoperatively collected autologous blood that is stored in and dispensed from the blood bank
  • Fibrin/platelet sealant manufactured for allogeneic use

Which Products are Exempt?

  • Products for further manufacturing use - recovered plasma, Source Plasma, Source Leukocytes
  • Devices - e.g., filters, apheresis instruments, blood collection sets
  • Intraoperative autologous blood collected and transfused in OR or RR; includes salvaged autologous blood that stays with patient
  • Autologous fibrin/platelet sealant manufactured and used intra-operatively
  • Drainage collected in OR or ER as part of trauma care

Machine Readable Information

  • Unique facility identifier (e.g., FDA registration number)
  • Lot number (unit or bleed number) relating the unit to the donor
  • Product code
  • ABO and Rh of the donor

Bar Code Information Requirements

  • Must be on container label
  • Must be unique to the blood component
  • Must be surrounded by sufficient blank space so information can be scanned correctly
  • Must remain intact under normal conditions of use

Symbology

  • Machine readable vs. Bar code
  • Did not specify a particular machine readable symbology to accommodate for new bar codes and changes in technology
  • FDA recognized Codabar in 1985
  • FDA approved ISBT 128 (v.1.2.0) in 2000
    • Some issues not consistent with regulations, requires variance submission

Bar Code Rule for Tissues

  • Applies to human cells, tissues and cellular/tissue-based products subject to pre-market approval under Sec. 351 of PHS Act
  • Does not apply to hematopoietic stem/progenitgor cells from peripheral or cord blood only regulated under Sec. 361 of the PHS Act
    • Autologous
    • First and second degree blood relatives

Are Exceptions Allowed?

  • Not consider requests based on:
    • Financial reason
    • Claim that there is a low rate of error associated with product
  • We will review requests if complying with rule:
    • Affects safety, purity, potency and effectiveness of product
    • Not technically feasible

Information and Guidance

Information and Guidance

  • Guideline for the Uniform Labeling of Blood and Blood Components (8/85)
    http://www.fda.gov/cber/guidelines.htm#95
  • Guidance for Industry: Recognition and Use of a Standard for the Uniform Labeling of Blood and Blood Components (6/6/00)
    http://www.fda.gov/cber/gdlns/unilabbld.htm
  • Manufacturers Assistance and Technical Training Branch of Office of Communication, Training and Manufacturers Assistance, CBER
    Email - matt@cber.fda.gov
 
Updated: May 2, 2006