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# Package Type Guidance
- URL: https://www.fdaweb.com/package-type-guidance/
- Published: 2018-10-02T12:00:00.000Z
- Updated: 2026-09-15T00:35:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142496

FDA has issued a guidance, *Selection of Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use*, with the agency’s recommendations on selection of appropriate package type terms and selection of appropriate discard statements for injectable medical products for human use packaged in multiple-dose, single-dose, and single-patient-use containers. Specifically, FDA says, the [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM468228.pdf?ref=fdaweb.com) gives revised definitions for single-dose and multiple-dose containers, as well as for the new package type term single-patient-use container. The containers may be part of a drug, a biological product, or a combination product assigned to CDER, CBER, or certain combination products assigned to CDRH.