Description
The Prescription Drug Marketing Act (PDMA) was enacted on April 22, 1988 (Public Law 100-293) to respond to problems relating to the safety, efficacy, storage and handling of pharmaceuticals. PDMA established specific requirements for the selling and distribution of prescription drugs. Included in these is a requirement that wholesale distributors of prescription drugs be state licensed according to FDA minimum standards. Nearly ten years after enactment of PDMA, on December 3, 1999, FDA published the final regulation completing the implementation of the Act. This final rule includes provisions dealing with the "authorized distributor of record" and "drug pedigree" elements of PDMA.

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Links

• HDMA's Comments to FDA on Removal of Certain Pedigree Requirements - September 6, 2011

• HDMA Comments on PDMA Paperwork Reduction Act Review - August 13, 2009

• HDMA Comments on PDMA Paperwork Reduction Act OMB Approval Request - May 15, 2009

• HDMA Testimony in Support of Safeguarding America's Pharmaceuticals Act (H.R. 5839)

• State Pedigree and Licensure Map

• The Facts About PDMA

• HDMA Baseline Technical Recommendations for Compliance With California Pedigree Law (PDF: 283K) - Note: These guidelines are subject to periodic review, and will be updated when necessary. Please be sure to review these guidelines periodically. 

Contacts
Dan Bellingham
Senior Director, State Government Affairs
703-885-0236
dbellingham@hdmanet.org

Anita Ducca
Vice President, Regulatory Affairs
703-885-0240
aducca@hdmanet.org

Liz Gallenagh
Vice President, Government Affairs and General Counsel
703-885-0234
egallenagh@hdmanet.org

Kristen Freitas
Senior Director, Federal Government Affairs
703-885-0232
kfreitas@hdmanet.org