FDA Drug Product Labels Validation Method

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

**Description**
The 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. 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.

**Benefits**
- helps in gathering product and facility information
- 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) of fda approved drugs can be obtained through this dataset.
- the "drug label" includes all published material accompanying a drug, such as the actual label on a prescribed dose as well as the package insert which contains a great deal of detailed information about the drug.

**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](https://www.johnsnowlabs.com/marketplace/) on John Snow Labs website. The subscription will allow you to use all John Snow Labs datasets and data packages for commercial purposes.

**Included Datasets**
- [Active Ingredient Active Moiety Relationship Validation Procedure](https://www.johnsnowlabs.com/marketplace/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.
- [Controlled Substances Schedule](https://www.johnsnowlabs.com/marketplace/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.
- [DEA Controlled Substance Validation Procedure](https://www.johnsnowlabs.com/marketplace/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.
- [DEA Exempted Substance Validation Procedure](https://www.johnsnowlabs.com/marketplace/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.
- [Structured Product Labeling Validation Procedures](https://www.johnsnowlabs.com/marketplace/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".
- [Vaccine Antigen Substance Validation Procedure](https://www.johnsnowlabs.com/marketplace/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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