Description
This guidance describes the Food and Drug Administration’s (FDA’s) Inactive Ingredient Database (IID) and provides recommendations for how to use the IID in the development of drug products. The guidance also describes how the IID can be used in evaluating excipient safety, which can affect application filing and scientific review. In addition, this guidance discusses how the IID is structured; the data regarding excipients in the IID; and how nomenclature, maximum potency levels, and units of measure are presented in the IID. Lastly, the guidance is intended to give IID users a clearer understanding of the database’s benefits and limitations.
Scope & Applicability
Product Classes
1Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Stakeholders
2responsible for justifying omission of studies
entity submitting marketing applications
Regulatory Context
Attributes
4highest level of an excipient in an FDA-approved product; IID currently provides only the maximum potency per dosage unit
limit for excipients like antioxidants or pH modifiers
solid oral drug product with a maximum daily intake of 2.5 grams
assessment of appropriateness of excipients based on total daily exposure
Related CFR Sections (2)
See Also (8)
- ANDA Submissions -- Refuse-to-Receive Standards Rev.2 (Status: Final)
- Replacing Color Additives in Approved or Marketed Drug Products: Draft Guidance for Industry (Status: Draft)
- CPG Sec 500.425 Use of Color Additives in Paper and Paperboard Intended for Use with Food (Status: Final)
- Guidance for Industry: Color Additive Petitions - FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices (Status: Final)
- Non-Invasive Blood Pressure (NIBP) Monitor Guidance (Status: Final)
- Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions (Status: Final)
- Small Entity Compliance Guide: Declaration by Name on the Label of All Foods and Cosmetic Products that Contain Cochineal Extract and Carmine (Status: Final)
- Guidance for Industry: Questions and Answers About the Food Additive or Color Additive Petition Process (Status: Final)