History of the PDMA & PDMA Regulations

History of the PDMA & PDMA Regulations

The Prescription Drug Marketing Act of 1987 (PDMA) was passed to regulate and prevent improper distribution of pharmaceutical product samples. The rules and procedures set forth by the FDA effective December 4, 2000 concludes, “Where a practitioner has a state license number, that number must be used for verification purposes” {21 CFR Parts 203.30(a)(2)}. Complicating these stringent requirements, each state and its individual boards independently maintain practitioner-licensing information. The need to obtain and consolidate state license information into a uniform and accessible database requires today’s best information technologies. MedProID® was implemented to aid pharmaceutical companies in achieving PDMA compliance. PDMA license validation is fully supported across the entire MedProID® suite of solutions. This includes support in WebID®, BulkID and WebServicesID®, AffiliationID®, BestInfoID®, Call Center, MobileID®, Practitioner ProximityID®, Sampleability Updates®, SanctionID® and Shippability®.

To learn more about Federal PDMA guidelines and compliance, please visit the FDA website: www.fda.gov

MedPro has been a Sharing Alliance member for over eighteen years, 2001 – Present, and an industry leader in pharmaceutical regulatory compliance solutions.

The Sharing Alliance

The Sharing Alliance, formerly known as The PDMA Alliance, is a not-for-profit organization dedicated to the ongoing education of its members on pharmaceutical sample compliance best practices. Since its founding in 1989, the focus has been improving the industry’s understanding the Prescription Drug Marketing Act of 1987 (PDMA) and related sample compliance regulations. Since then, the Alliance’s focus has also expanded to include other areas critical to a strong regulatory compliance program such as OIG Guidelines, Corporate Integrity Agreements, Open Payments, Aggregate Spend, the Drug Supply Chain Security Act, 340B Drug Pricing Program, and more. MedPro Systems ® has supported The Sharing Alliance since the earliest days of MedProID® and looks forward to many future years of participation and mutual shared benefits with The Sharing Alliance.

To learn more about The Sharing Alliance, please visit their website: sharingalliance.org

Please contact us for more information on MedPro's PDMA license validation solutions.

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