Navigation Links
Coping With New FDA Mandates For Drug Sample Distribution
Date:5/14/2012

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: https://www3.gotomeeting.com/register/218892550.

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.

www.dclab.com

Steve Capoccia
617-372-1539
steve@warnerpr.com


'/>"/>
SOURCE Data Conversion Laboratory, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Enrollment of Women in Cardiovascular Trials Fails to Meet Current Federal Mandates
2. CRN Opposes Duplicative Mandates for Supplement Manufacturers
3. New PCMA Ad on Essential Health Benefits: Small Businesses Oppose Costly Mandates Pushed by Drugstore, Drug Company Lobbies
4. PCMA on IOM Essential Health Benefits Report: Employers and Special Interests Will Spar Over Costly Prescription Drug Mandates
5. MicroRNA Biomarkers Provide Reliable Diagnosis from Blood Samples
6. ASPEX Kicks Off Free Send Us Your Sample Microscopy Campaign
7. One-Third of Antimalarial Medicines Sampled in Three African Nations Found to Be Substandard in Large-Scale USP-WHO Study
8. Transgenomic Demonstrates Very High Sensitivity Detection of Tumor-Associated KRAS Mutations in Matched Plasma Samples Using COLD-PCR
9. PLUS Diagnostics Introduces Industrys First System to Eliminate Misidentification of Bone Marrow Samples
10. Amnis Releases AutoSampler Option for the ImageStreamX
11. New England Biolabs Launches NEBNext™ Quick DNA Sample Prep Reagent Sets for Use With Roche/454 Next Generation Sequencing Platforms
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/6/2017)... Sept. 6, 2017 Eli Lilly and Company ... present new data for galcanezumab and lasmiditan, two investigational ... International Headache Society (IHC) taking place Sept. 7-10 in ... will highlight new, long-term data from an open-label study ... galcanezumab (120 mg and 240 mg) for the prevention ...
(Date:9/5/2017)... 2017  Just 18 months after its February 2016 ... announce the appointment of three new senior people to ... Dominic Jones-Phillips and James Wright bring ... Tammy Wynne joins as ... writers. She has over ten years, experience in global ...
(Date:9/1/2017)... -- Bayer will present the latest research from across its growing ... 2017 Congress, September 8-12 in Madrid, Spain ... data on Bayer,s marketed portfolio and late-stage compounds as well ... "We value the opportunity to meet ... ESMO," said Carsten Brunn , Head of Pharmaceuticals, Americas ...
Breaking Medicine Technology:
(Date:9/25/2017)... Angeles, CA (PRWEB) , ... September 25, 2017 , ... ... of a full-time office in downtown Los Angeles, to service existing clients in the ... surrounding areas. , “We are seeing an ever-increasing amount of business demand west of ...
(Date:9/24/2017)... ... , ... Bhowanie Benimadhu’s new book “ Our Creative World: Our Created Life ... answers in both Eastern and Western religious traditions and spirituality such as Hinduism ... of humankind for the past thousands of years and still are,” Benimadhu says. “By ...
(Date:9/24/2017)... ... September 24, 2017 , ... The Tuscany Resort on Grace Bay in ... Provo's premier boutique resorts, is planning on re-opening the resort on October 1st. ... Irma and more recently Hurricane Maria, and the staff and landscaping crews were fast ...
(Date:9/24/2017)... ... ... “Star of Bethlehem Study”: is a thought-provoking essay focusing on the most ... Duane Engdahl, an investigator who had has a long and eventful career in science ... a thought-provoking essay an event so significant that it is referred to as the ...
(Date:9/23/2017)... ... 23, 2017 , ... “You Can't Win Them All”: the story of an ... and on the ice changed the lives of young athletes. “You Can't Win ... born and educated in Schreiber, a small town in Northern Ontario, Canada. He ...
Breaking Medicine News(10 mins):