Pressroom

Fresh Meadows, NY:  Pharmaceutical manufacturers and distributors face new Food and Drug Administration (FDA) mandates requiring the reporting of the distribution of drug product samples, according to Data Conversion Laboratory. The reporting is to be done using XML files and through gateway submissions.

To help the pharmaceutical industry cope with the new federal requirements, as well as existing SPL rules, DCL is offering a free, 90-minute webinar on May 17th covering the new regulation, and best practices in SPL.

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

"The benefits of SPL are significant, as manufacturers and distributors can create one XML master document that includes all of the labeling information for a given product and from that master the appropriate data can 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 Howard Shatz, project manager, DCL, who will lead the seminar. "The result is that data is created once, but used many times and it is very efficient for tracking and reporting purposes," he added.

The new FDA reporting requirement, formally known as Patient Protection and Affordable Care Act's (ACA) Prescription Drug Sample Transparency Program (ACA 6004) was effective by April 1st, but the FDA will not object to late submissions made by October 1st for 2012.

The ACA 6004 program requires the annual reporting of drug sample distributions to licensed practitioners, hospital pharmacies, and other healthcare entities. The new law requires electronic records that identify the type and quantity of drug samples requested, the identity and quantity of drug samples distributed and the name, address, professional designation, and verification that the manufacturer or distributor has the signature of any person who makes or signs for the request.

Shatz is an expert in SPL requirements for all product types, as well as the reporting requirements for ACA 6004. His expertise extends to prescription drugs, consumer products, veterinary medicine, homeopathic products and bulk ingredients. He is an active member of the SPL Working Group, serving on many of the sub-teams. He has been with since 1991 and DCL has been doing SPL conversions for seven years, since the program began.

The May 17th webinar is divided in two parts. The first part will cover the "Do's and Don'ts" of SPL conversion, and how to streamline the process for accuracy and savings; and the second part will be on the new ACA 6004 draft requirements. Topics to be covered include how to prepare SPL submissions, such as addressing Label Image Size and Legibility requirements, entering information for Establishment Registration, National Drug Code Labeler Code Request, and for drug labels, and making the Gateway Submission correctly.