[April 2008]

Subject:

Labeler Code, VetMed, Contact Information

Question:

We have labeler codes for animal products and human, with different contact information, same DUNS number Will there be an issue?

Answer:

Your labeler code for animal products would be associated with your contact information and would have a unique setID.

Reference(s) :

Q&A Session at FDA-hosted webinar April 2008


[April 2008]

Subject:

Inactive Ingredient, VetMed, Medicated Feed

Question:

For carriers in medicated feeds, do we need to include those in the inactive ingredients?

Answer:

Follow your current process. If you don’t currently include them in drug listing, you wouldn’t include them in SPL.

Reference(s) :

Q&A Session at FDA-hosted webinar April 2008


[April 2008]

Subject:

NADA number, VetMed

Question:

What if an animal product doesn’t have a NADA number?(e.g., an animal OTC product)

Answer:

You wouldn’t put anything in the Marketing Category number field.

Reference(s) :

Q&A Session at FDA-hosted webinar April 2008


[April 2008]

Subject:

VetMed, Labeler Code, Packaging

Question:

Is Animal Health going to be required to place labeler code or NDC code on the packaging?=== ===

Answer:

The use of SPL has nothing to do with any changes to packaging elements

Reference(s) :

Q&A Session at FDA-hosted webinar April 2008