The FDA Global Substance Registration System (G-SRS) is a database application used by the FDA to register, maintain, index and analyze substance data based on the IDMP ISO 11238 data model. FDA experts use this system to maintain detailed information on substances found in FDA-regulated drugs, biologics, supplements, cosmetics and foods and to establish a UNique Ingredient Identifier (UNII) for every substance considered unique and unambiguous. To maintain the complex array of substances relevant to FDA’s mission, the FDA G-SRS system must support detailed structural information on a wide variety of diverse materials including small molecules, polymers, monoclonal antibodies, as well as plant and animal-derived materials. The FDA G-SRS is built on the freely distributable G-SRS software written in a collaboration between FDA and the National Center for Advancing Translational Science (NCATS). Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information. In the past few years the standard has been gradually extended to cover a growing number of product-related topics. One of the challenges has been to adapt the standard for describing substances used as ingredients in products. For small molecule ingredients inclusion in the SPL file of the structure representation by a MOL file and the IUPAC chemical identifier InChI was typically sufficient to both convey the structure and uniquely identify it. However, for more complex materials, such as biopharmaceuticals, more significant adjustments were necessary. The main challenges have been representing the polydispersity of materials and ensuring that the information is conveyed in an unambiguous and reproducible way. We describe how the structural information on biopharmaceutical substances is represented in the GSRS and SPL, how we approach uniqueness check and similarity analysis, and how we can convey information provided by other sources such as International Nonproprietary Names (INN), US Adopted Names (USAN), UniProt, and Chemical Abstract Service (CAS).

Representation of biopharmaceutical substances in the FDA global substance registration system and in the structured product labeling

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.