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FDA Inactive Ingredient Database
Update
ExcipientFest April 27, 2016 Susan Zuk
Office of Policy for Pharmaceutical Quality
OPQ, CDER, FDA
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January 2015
Challenges
• Data transfer to a new system
• Publication delay
• Inaccurate data
• Unreliable data
• Backlog
2015 Backlog - 4000 Formulas
3
0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
IID 2013 Integrity 2015 Integrity only 2015 Backlog of Products
11,788
13,347
2152
3815
Inactive Ingredients
Product
formulas to
be entered
New entries
April 2015
• Clean-up project begins
– Backlog of 4000 formulas
– Corrections and missing entries
• Entry of new approvals resumes
• Publication resumes
• Enhanced QC
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Review Correct Confirm Publish
April 2016
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Progress on the Backlog
Figure courteously of Alex Doura, CDER Office of Business Informatics, FDA
Newly Approved Products
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>1000 Applications
approved since 2014
100% new NDAs entered into the database
100% new ANDAs entered into the database
Soliciting Input from Stakeholders
FR Notice [FR Doc. 2015-20556] August 2015
• How can we improve nomenclature?
• How should we identify excipient amounts?
• How should we reflect updates?
• Should we restructure the IID?
• Suggestions for IID improvement. 7
How can we improve nomenclature?
How should we
identify excipient
amounts?
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August 2015
• Began standardizing units
Converted units for topical products
% %w/w, %w/v, %v/v
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October 2015
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Converted oral liquids
% weight per dose (X mg/X mL)
Other Dosage Forms
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Transdermal Systems (TDS)
• ingredients are listed as mg per system
• composition statement should list ingredients in
each layer separately for clarity
Which layers should be included in the IID?
Is maximum potency needed for all layers?
Figure courtesy of Robert Berendt, OPQ, CDER, FDA
Other Dosage Forms
• We are currently determining the best way
to represent potency in other dosage
forms.
• How should ingredient potencies be stated
in these products?
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Metered
Dose Inhaler Nasal Spray
Intrauterine
Device
Questions?
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Acknowledgments
CDER Excipient Working Group
Office of Business Informatics, CDER
Ashley Boam, OPPQ, OPQ, CDER
Thank you
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