Subject:

Include both Active & Inactive Ingredients in Data Elements?

Question

Are the active and inactive ingredients included in the data elements?

Answer:

Yes. All the active ingredients and most inactive ingredients in the content of labeling are included as data elements.
References: SPL Standard for Content of Labeling Technical Qs & As http://www.fda.gov/cder/guidance/7074fnl.htm




[Nov 13, 2008]

Include all Inactive Ingredients?

Question

Do we have to include all inactive ingredients?

Answer:

Inactive ingredients should be included, along with the UNII code for each inactive ingredient. Do not include products (such as certain dyes, flavorings) or non-specific descriptions (flavorings, amino acids). If an inactive ingredient is not currently on the UNII code list, request a UNII code by contacting spl@fda.hhs.gov .

References:



[Nov 13, 2008]

Include strengths for Inactive Ingredients?

Question

Do we have to include strengths on inactive ingredients? Our content of labeling (CoL) does not include this.

Answer:

If available, strengths should be included with inactive ingredients. Validation rules for Release 4 SPL do not require strengths as part of the inactive ingredient information.

References: SPL R4 validation rules



[Nov 11, 2008]

Include Establishment Information for manufacturers of Inactive Ingredients?

Question

Does the establishment information for a manufacturer of one or more inactive ingredients in a product need to be included in the Establishment Registration?

Answer:

No. Establishment information for manufacturers of inactive ingredients does not need to be include.
References: DIA F2F October 29-30, 2008. Presentation on Drug Listing