SPL and SPL R4

SPL-Prefered Substance Name

In SPL, FDA provides terminology list, which has some terms with specific codes.

For Prefered substance name too, UNIIs are refered. They are used in Active substance and Inactive substance name. UNII is an excel file with prefered substance and substance name and UNII codes against each prefered substance name. For SPL, prefered substance name are to be used.

Now, sometimes it happens that, their is no UNII code for a substance name, i.e. their is even not the substance name in UNII list. In that case, we can exclude that substance name (ingredient name) from the SPL. This is acceptable. Thus, the bottom line is that if their is no prefered substance name available and the SPL contains such substance name, then it can be excluded from the SPL and such SPL can be submitted to FDA.

Author

KnetAdmin

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