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Coping With New FDA Mandates For Drug Sample Distribution

FRESH MEADOWS, N.Y., May 14, 2012 /PRNewswire/ -- Pharmaceutical manufacturers and distributors face new Food and Drug Administration (FDA) mandates requiring reporting on drug product samples distribution using XML, and submitting the report through the FDA gateway.

To help the pharmaceutical industry cope with the new federal requirements and also to understand best practices for ongoing Standard SPL filings, Data Conversion Laboratory (DCL) is offering a free, 90-minute webinar on May 17th.

The webinar is in two parts with part one covering SPL best practices to streamline the process for accuracy and savings, and part two on the new ACA 6004 draft requirements. Topics include preparing SPL submissions, Label Image Size and Legibility requirements, Establishment Registration, National Drug Code Labeler Code Requests, and Gateway Submission. To register visit:

SPL is a document markup standard used by the FDA community to facilitate the communication of drug labeling data reliably between the FDA, drug makers and distributors, hospitals, prescribing organizations, doctors and the general public.

"SPL allows manufacturers and distributors to create an XML master document that centralizes all the labeling information for a given product and allows it to be accurately and efficiently distributed to the National Drug Code Directory, the DailyMed, the Centers for Medicare and Medicaid Services, and clinical decision support systems at health facilities," said DCL's Howard Shatz, who will lead the seminar. "The result is that data is created once, but used for many purposes with total accuracy," he added.

The new ACA 6004 program requires annual reporting of drug sample distributions to licensed practitioners, hospital pharmacies, and other healthcare entities; electronic records must now identify the types and quantities of drug samples requested and distributed and the name, address, as well as other identifying information.  The Patient Protection and Affordable Care Act's (ACA) Prescription Drug Sample Transparency Program (ACA 6004) was effective April 1st, but the FDA has stated they will not object if companies report by October 1st.

Shatz is an expert on SPL and ACA 6004 requirements for prescription drugs, consumer products, veterinary medicine, homeopathic products and bulk ingredients. An active member of the SPL Working Group, he has been DCL's SPL Project Manager since the FDA's program started in 2005.

About Data Conversion Laboratory, Inc. DCL is a leader in organizing, converting, and moving content to modern formats for wide access and new revenue streams. With expertise across many industries, DCL's proprietary technology matched with US-based project management teams solve clients' complex conversion challenges securely, accurately and on-time. Serving the full range of businesses, government, nonprofits and individuals by future-proofing their content, DCL started in 1981 and is a 100 Top Company in the Digital Content Industry for 2011-2012.

Steve Capoccia

SOURCE Data Conversion Laboratory, Inc.
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