Be sure to check out this exclusive webinar which covers the common pitfalls when converting to SPL as well as the new FDA mandate: Drug Sample Transparency Act (ACA6004).
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 & the general public. SPL is both a HL7 & ANSI approved standard. Since 2005, the FDA CDER division has provided guidance that all human prescription products be provided in SPL. Other FDA divisions responsible for other types of products required SPL filing beginning in June of 2009. These divisions include:
Biologics (CBER)
Veterinary (CVM)
Office of Nonprescription Products (ONP)
Medical Devices (CDHR) Timing TBD
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 & bulk ingredients.
DCL's SPL process includes:
Client completes DCL designed spreadsheet for drug product listing information
Client provides source & packaging labels
DCL completes the conversion of documents to XML-SPL
DCL provides delivery of SPL folder ready for gateway submission
Support the following requirements
Establishment registrations
NDC labeler code requests
Drug product listings
Content-of-Labeling
High volume bulk conversions
Individual labels
Guaranteed performance
Drug Sample Transparency Act (ACA 6004)
The FDA is now requiring that pharmaceutical manufacturers and distributors report their distributions of drug samples under the Drug Sample Transparency Act (ACA 6004) specification. Like SPL, the 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. Be sure to check out DCL's exclusive webinar addressing many of the common pitfalls with SPL as well as details concerning the new ACA 6004 specification.
DCL also provides consulting and project management services for organizations that have or plan to develop internal capabilities. Our expert team of professionals will ensure your project is planned effectively, efficiently, and will be available to train & mentor through the project development.
