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Drug Manufacturers and the New FDA Drug Listing Rules – a Primer from Data Conversion Laboratory
Free webinar on October 26 at www.dclab.com to help drug manufacturers navigate the new rules
Fresh Meadows, NY – October 23, 2017 – Data Conversion Laboratory (DCL) is offering a free webinar on October 26 at 1:00pm ET to explain the new FDA drug listing rules, which will be affecting all U.S. drug listings.
The webinar, titled “New FDA Drug Listing Rules: Understanding the New FDA Rules For Updating Drug Listings and Annual No Changes Certification” will be presented by Howard Shatz, SPL Project Manager at DCL and will dive into the details of the new rule and the requirements for certifications.
“Change can be challenging, but the FDA is requiring it in order to ensure that the current drug listing data is accurate,” said Shatz. “The major change is that all paper drug listings will now need to be submitted as SPL; for companies that have previously done SPL listings the process should be familiar, but for others there will be a learning curve. The regulations continue to require that companies update their listings by the following June or December for any changes, but now also require that unchanged labels be so certified. A primary objective of the webinar will be to make any transition much easier.”
SPL is an XML data standard used by the FDA community to facilitate the communication of drug labeling data quickly and reliably among various groups such as the FDA, hospitals, prescribing organizations, doctors, and the general public. The complete drug listings are available through public sites such as NLM’s DailyMed and FDA’s Online Label Repository.
The following are the primary changes to the new FDA drug listing rules:
All drug products must now be listed using SPL; drug products listed previously using paper forms (before June 2009) must be listed in SPL in 2017
Beginning with 2017, every year every SPL drug label must either:
○ Be re-submitted, updated as needed, during a calendar year, or
○ Have their product codes included in a new type of SPL file, Blanket No Change Certification, submitted in the period October 1 – Dec 31.
Whether submitted as an individual label or included in a Blanket No Change Certification file, the currently-listed SPL drug label must be accurate across all aspects, including the content of labeling, drug product information, establishment information, package images.
DCL is a leader in content conversion and regulatory and compliance services such as SPL & ACA6004. Its experts are available to help organizations plan and execute on getting their drug labeling to comply with the new rules. More information is available at DCL’s SPL resource page.
For over 35 years, DCL has been a leader in regulatory and compliance services such as SPL & ACA6004, and helping organizations maximize the value of their content assets investment through digitization and organization, making reuse easier, and providing greater accessibility. DCL’s teams are experts in converting content into all structured formats, including XML, S1000D, SGML, proprietary schemas, and others. DCL is a multi-year winner of EContent’s Top 100 companies.