Navigation Links
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.
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:
(Date:6/24/2016)... , June 24, 2016 Dehaier Medical ... the "Company"), which develops, markets and sells medical devices ... , signed a strategic cooperation agreement with Hongyuan ... "Hongyuan Supply Chain") on June 20, 2016, to develop ... the strategic cooperation agreement, Dehaier will leverage Hongyuan Supply ...
(Date:6/24/2016)... India , June 24, 2016 ... Needles Market by Type (Standard Pen Needles, Safety Pen ... Therapy (Insulin, GLP-1, Growth Hormone), Mode of Purchase (Retail, ... by MarketsandMarkets, This report studies the market for the ... expected to reach USD 2.81 Billion by 2021 from ...
(Date:6/24/2016)... 2016  Arkis BioSciences, a leading innovator in ... durable cerebrospinal fluid treatments, today announced it has ... is led by Innova Memphis, followed by Angel ... investors.  Arkis, new financing will accelerate the commercialization ... release of its in-licensed Endexo® technology. ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... 2016 , ... On June 10-11, 2016, A Forever Recovery, a holistic treatment ... Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is located. This ... of the world’s leading providers of cereal and other breakfast foods. Its residents often ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... ... health policy issues and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, ... work on several important health care topics including advance care planning, healthcare costs ...
(Date:6/25/2016)... Long Beach, CA (PRWEB) , ... June 25, 2016 , ... ... from UCLA with Magna Cum Laude and his M.D from the David Geffen School ... San Diego and returned to Los Angeles to complete his fellowship in hematology/oncology at ...
(Date:6/24/2016)... ... ... Those who have experienced traumatic events may suffer from a complex set of ... or alcohol abuse, as a coping mechanism. To avoid this pain and suffering, Serenity ... event. , Trauma sufferers tend to feel a range of emotions, from depression, guilt, ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. Amanda Cheng, an ... Dr. Cheng has extensive experience with all areas of orthodontics, including robotic Suresmile ... orthodontics. , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. It can ...
Breaking Medicine News(10 mins):