The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
FDA Guidance for Industry: Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products
Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use
Containers1 for Human Use
This guidance provides industry with the Food and Drug Administration's (FDA's) recommendations on the selection of appropriate package type terms and selection of appropriate discard statements3 for injectable medical products for human use, packaged in multiple-dose, single-dose, and single-patient-use containers