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Substance Registration System – UNII Presentation

Substance Registration System – UNII Presentation

Presentation: March 20, 2007 

William A. Hess, CAPT 

Food and Drug Administration

 

SRS/UNII Purpose

 

The overall purpose of the joint FDA/USP Substance Registration System (SRS) is to support health information technology initiatives by providing unique ingredient identifiers (UNII) for substances in drugs, biologics, foods, and devices based on molecular structure and/or descriptive information.

 

 

 

SRS/UNII Design 

 

  • The SRS uses molecular structure and descriptive information to define a substance and generate the UNII. 
  • The primary means for defining a substance is by its molecular structure represented on a two-dimensional plane. 
  • When a molecular structure is not available (e.g., botanicals), the UNII is defined by descriptive information. 
  • When a molecular structure alone is insufficient (e.g., polymers), the UNII is also defined by descriptive information. 
  • The UNII consists of ten alphanumeric characters. 
  • The first nine alphanumeric characters are randomly generated. 
  • The tenth alphanumeric character is determined through a mathematical algorithm, and is appended to the first nine.

 

SRS/UNII Rules 

 

  • Substances that are registered in the SRS follow detailed business rules for that registration which were developed by the SRS Project Management Team. 
  • In addition, substances that are registered in the SRS follow a detailed and robust set of data rules that were developed by the SRS Board for drawing molecular structures and representing descriptive information. 
  • The SRS Board consists of experts from both the USP and FDA, and it works very closely with drug regulators from other nations in the development of these rules.

 

SRS/UNII Scope 

 

  • Foods 
    • Food substances are specific foods or components of food, regardless of whether the food is in conventional food form or a dietary supplement, such as vitamins, minerals, herbs, or other similar nutritional substances. 
  • Drugs 
    • Drug substances include both active and inactive ingredients used in drug products, including those for veterinary purposes. 
  • Biologics 
    • Biologic substances include both active and inactive ingredients used in biologics, such as blood products, therapeutic products, vaccines, cellular and gene therapy products, allergenic products, tissues, and certain devices (e.g., enzymes in stabilized solutions). 
  • Devices 
    • Device substances include certain components of some devices (e.g. silicon for implants, and chemical reagents for glucose test kits). 
  • Cosmetics 
    • Cosmetic substances are components of cosmetic products, such as flavors, fragrances, colorants, vitamins, plant- and animal-derived ingredients, and polymers.

 

SRS/UNII Questions

 

Questions about the UNII should be directed to: 

CAPT William A. Hess 

william.hess@fda.hhs.gov