Why is text I included for an ingredient missing from the Drug Product Listing tablefor example, why does “water for injection” appear as just “water”?
A. In the Drug Product Listing (DPL) part of the SPL, which is intended for computer processing rather than printed output, the FDA uses only the name of the ingredient, with no description. DCL edits the data in the DPL to conform to instructions received from the FDA, dropping the following descriptive terms from ingredients: for injection may contain may include NF Purified Sterile q.v. USP v/v w/v WFI (becomes water) %s (for example, Alcohol 5% becomes Alcohol) This list is subject to change based on further instructions from the FDA. In the narrative sections, such as Description, which appear in printed output, the text for ingredients remains as you provide it, including descriptions.
Related Questions
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- Why is text I included for an ingredient missing from the Drug Product Listing tablefor example, why does "water for injection" appear as just "water"?
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