Structured Product Labeling (SPL)

Structured Product Labeling (SPL) is a standard used by the FDA community to facilitate the communication of drug labeling data reliability among various groups such as the FDA, hospitals, prescribing organizations, doctors, and the general public. SPL is an HL7 and ANSI-approved standard. Since 2005, the FDA CDER division has provided guidance that all human prescription products be provided in SPL. Other FDA divisions have required SPL filing since June of 2009, including: 

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• Biologics (CBER)

• Veterinary (CVM)

• Office of Nonprescription Products (ONP)

• Medical Devices (CDHR)

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DCL’s professional team is expert in offering comprehensive SPL conversion services to handle all product types. DCL is a member of SPL Working Group. Our SPL conversion services include prescription drugs, OTC products, veterinary medicine, homeopathic products, and bulk ingredients. We also provide consulting and project management services for organizations that have or plan to develop internal capabilities. This hybrid approach will ensure your project is planned effectively and efficiently. We will be available to train and mentor your internal team throughout the project development. 

 

DCL’s SPL process includes: 

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• Client completes DCL designed spreadsheet for SPL information except for content of labeling and images

• DCL converts content of labeling documents (for drug listings) and client-completed spreadsheet to XML-SPL

• DCL crops and resizes images

• DCL provides delivery of SPL folder ready for gateway submission

 

DCL supports the following requirements:

• Lot Distribution Reports and Blanket No Change Certifications

• Generic Drug Facility Self-Identification

• Blanket No Change Certification

• Human-Compounded Drug Label

• Bulk ingredient listings

• Wholesale Drug Distributor/Third-Party Logistics Facility Report

• Gateway submissions (optional)

 

 

Drug Sample Transparency Act (ACA6004)

The FDA now requires pharmaceutical manufacturers and distributors to report their distributions of drug samples under the Drug Sample Transparency Act (ACA 6004) specification. Like SPL, reporting is done using XML and through the FDA’s Electronic Submissions Gateway. DCL can review your ACA 6004 data on the distributions, and either convert it to XML as is or, as with SPL, provide a workbook for you to enter the data. You can then either submit the XML through the gateway or have us submit it for you.