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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

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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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