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    FDA Drug Product Labels Validation Method

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    Deployed on AWS
    This data package contains information on Structured Product Labeling (SPL) Terminology for SPL validation procedures and information on performing SPL validations.

    Overview

    Overview

    The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by the FDA as a mechanism for exchanging product and facility information. SPL documents contain both the content of labeling (all text, tables and figures) for a product along with additional machine readable information (drug listing data elements). Drug listing data elements include information about the product (product and generic names, ingredients, ingredient strengths, dosage forms, routes of administration, appearance, DEA schedule) and the packaging (package quantity and type). This data package is a Structured Product Labeling (SPL) Terminology File for SPL validation procedures and contains information on performing SPL validation regarding Active Ingredient-Active Moiety Relationship/Basis of Strength, Combination Product Type Category, DEA (Drug Enforcement Administration) Controlled Substance List, Final All Over-the-Counter (OTC) Drugs Monograph, Final Over-the-Counter (OTC) Drugs Monograph, Not Final Over-the-Counter (OTC) Drugs Monograph and Vaccine Antigen Substances.


    License Information

    The use of John Snow Labs datasets is free for personal and research purposes. For commercial use please subscribe to the Data Library  on AWS. The subscription will allow you to use all John Snow Labs datasets and data packages for commercial purposes.


    Metadata

    DescriptionValue
    Data Package ComplexitySimple
    Available EnrichmentsN/A
    KeywordsSPL, Drug Dictionary, Pharmaceutical Dictionary, Drug Labels, Active Ingredient, Drug Enforcement Administration, DEA, OTC Drugs, Drug Monograph List, Vaccines Antigen Validation
    Other TitlesActive Ingredient-Active Moiety Validation Procedures, Combination Product Type Validation Methods, DEA Schedule Controlled Substance List, SPL Validation Files for DEA Schedule, SPL Validation Files for DEA Schedule

    Included Datasets

    1. Active Ingredient Active Moiety Relationship Validation Procedure

    This dataset is a Structured Product Labeling (SPL) Terminology File for SPL validation procedures and contains information on performing SPL validation regarding Active Ingredient-Active Moiety Relationship/Basis of Strength.

    1. Controlled Substances Schedule

    This dataset identifies Drug Enforcement Administration number, which category (from I to V) the controlled substance is in, whether or not it is narcotic and other names of the controlled substances.

    1. DEA Controlled Substance Validation Procedure

    This dataset is a Structured Product Labeling (SPL) Terminology File for SPL validation procedures and contains information on performing SPL validation regarding DEA (Drug Enforcement Administration) Controlled Substance List.

    1. DEA Exempted Substance Validation Procedure

    This dataset is a Structured Product Labeling (SPL) Terminology File for SPL validation procedures and contains information on performing SPL validation regarding DEA (Drug Enforcement Administration) Exempted Substance List.

    1. Structured Product Labeling Validation Procedures

    This dataset is a Structured Product Labeling (SPL) Terminology File for SPL validation procedures and contains information on performing SPL validation of the "Final Over-the-Counter (OTC) Drugs Monograph", "Final All Over-the-Counter (OTC) Drugs Monograph", "Not Final Over-the-Counter (OTC) Drugs Monograph" and "Combination Product Type Category under the NCI Code C102833".

    1. Vaccine Antigen Substance Validation Procedure

    This dataset is a Structured Product Labeling (SPL) Terminology File for SPL validation procedures and contains information on performing SPL validation regarding Vaccine Antigen Substances.


    Data Engineering Overview

    We deliver high-quality data

    • Each dataset goes through 3 levels of quality review
      • 2 Manual reviews are done by domain experts
      • Then, an automated set of 60+ validations enforces every datum matches metadata & defined constraints
    • Data is normalized into one unified type system
      • All dates, unites, codes, currencies look the same
      • All null values are normalized to the same value
      • All dataset and field names are SQL and Hive compliant
    • Data and Metadata
      • Data is available in both CSV and Apache Parquet format, optimized for high read performance on distributed Hadoop, Spark & MPP clusters
      • Metadata is provided in the open Frictionless Data standard, and its every field is normalized & validated
    • Data Updates
      • Data updates support replace-on-update: outdated foreign keys are deprecated, not deleted

    Our data is curated and enriched by domain experts

    Each dataset is manually curated by our team of doctors, pharmacists, public health & medical billing experts:

    • Field names, descriptions, and normalized values are chosen by people who actually understand their meaning
    • Healthcare & life science experts add categories, search keywords, descriptions and more to each dataset
    • Both manual and automated data enrichment supported for clinical codes, providers, drugs, and geo-locations
    • The data is always kept up to date – even when the source requires manual effort to get updates
    • Support for data subscribers is provided directly by the domain experts who curated the data sets
    • Every data source’s license is manually verified to allow for royalty-free commercial use and redistribution.

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    About Us

    John Snow Labs , an AI and NLP for healthcare company, provides state-of-the-art software, models, and data to help healthcare and life science organizations build, deploy, and operate AI projects.

    Details

    Delivery method

    Deployed on AWS
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    Pricing

    FDA Drug Product Labels Validation Method

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    This product is available free of charge. Free subscriptions have no end date and may be canceled any time.
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    No refunds offered. For any questions email us at info@johnsnowlabs.com 

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    Usage information

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    Delivery details

    AWS Data Exchange (ADX)

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    Additional details

    Data sets (6)

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    You will receive access to the following data sets.

    Data set name
    Type
    Historical revisions
    Future revisions
    Sensitive information
    Data dictionaries
    Data samples
    Active Ingredient Active Moiety Relationship Validation Procedure
    All historical revisions
    All future revisions
    Not included
    Controlled Substances Schedule
    All historical revisions
    All future revisions
    Not included
    DEA Controlled Substance Validation Procedure
    All historical revisions
    All future revisions
    Not included
    DEA Exempted Substance Validation Procedure
    All historical revisions
    All future revisions
    Not included
    Structured Product Labeling Validation Procedures
    All historical revisions
    All future revisions
    Not included
    Vaccine Antigen Substance Validation Procedure
    All historical revisions
    All future revisions
    Not included

    Resources

    Vendor resources

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