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.
Recommended Actions
- Review current package type terms used across product portfolio
- Identify products requiring updates to align with new definitions
- Update labeling to include appropriate package type terms and discard statements
- 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
- Implement antimicrobial effectiveness testing for multiple-dose containers if required
- Ensure consistent package type terminology across all labeling components
- 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
- Changes to package type terms must be submitted through appropriate regulatory pathways
- Implementation timeline of 2 years recommended for labeling changes
- Specific submission requirements based on type of labeling change
Relevant Guidances
- Medical Device Convenience Kits - Premarket Notification and Compliance Requirements
- Medical Device Kit Component Certification Requirements for 510k Submissions
- Unique Device Identification Requirements for Convenience Kits
Related references and norms
- 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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