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Selection of Package Type Terms and Discard Statements for Injectable Medical Products

This guidance provides recommendations on selecting appropriate package type terms and discard statements for injectable medical products for human use packaged in multiple-dose, single-dose, and single-patient-use containers. It applies to drugs, biological products, and combination products assigned to CDER, CBER, or certain CDRH-led combination products.

  1. Review current package type terms used across product portfolio
  2. Identify products requiring updates to align with new definitions
  3. Update labeling to include appropriate package type terms and discard statements
  4. Submit changes through proper regulatory pathways within 2 years:
    • Annual report for “single-use” to “single-dose” changes
    • Prior Approval Supplement for other package type term changes
    • CBE-0 supplement for ANDA conforming changes
  5. Implement antimicrobial effectiveness testing for multiple-dose containers if required
  6. Ensure consistent package type terminology across all labeling components
  7. Add appropriate discard statements where required

Key Considerations

Non-clinical testing

  • Antimicrobial effectiveness testing required for multiple-dose containers
  • Some products may have inherent antimicrobial properties without preservatives

Labelling

  • Package type term should appear on all components of labeling when space permits
  • Single-dose containers must include “single-dose” term on label when required by USP monograph
  • Appropriate discard statements required for single-dose and single-patient-use containers
  • Multiple-dose containers typically use 28-day beyond-use date unless otherwise specified
  • Package type terms must be consistent throughout all labeling components

Safety

  • Single-dose containers are for single patient, single injection/infusion use
  • Multiple-dose containers generally limited to 30mL or less
  • Single-patient-use containers are for multiple uses in a single patient only

Other considerations

  • USP <659>: Packaging and Storage Requirements
  • USP <7>: Labeling

Original guidance

  • Selection of Package Type Terms and Discard Statements for Injectable Medical Products
  • HTML / PDF
  • Issue date: 2018-10-03
  • Last changed date: 2019-05-31
  • Status: FINAL
  • Official FDA topics: Chemistry, Pharmaceutical Quality, Medical Devices, Manufacturing, Drugs, Combination Products, Biologics, and Controls (CMC)
  • ReguVirta summary file ID: 572c0eb7de9449fe8d5745b4935134a6
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