HDMA Calls For Federal Licensure of

Nation’s Healthcare Distributors

The Healthcare Distribution Management Association (HDMA) has called for tough, uniform federal licensing standards for prescription drug distributors to further secure the pharmaceutical supply chain and enhance patient safety.

“The time has come for uniform, federal standards for the licensing of pharmaceutical distributors,” said HDMA president and CEO John M. Gray. “Maintaining the integrity of the United States’ prescription drug supply is a compelling national priority that requires a national solution involving members of the supply chain working closely with government.

“HDMA pledges to continue to work with lawmakers and regulators at the federal and state levels to ensure that the resulting regulatory framework enhances supply chain security, while maintaining a reliable and efficient supply of medicines for patients.” Gray added that “licensing standards, by their very nature, demand a consistent, coordinated approach.”

HDMA points out that in an era of increasingly sophisticated domestic and international threats to the nation’s prescription drug supply, the current variability in state regulatory standards for inspecting and licensing prescription drug distributors is unable to provide the strong and consistent regulation necessary to bolster the security of the supply chain and protect the public safety.

“We recognize that many states struggle with resources and with regulating distributors in an industry that is increasingly shipping across state lines. However, today’s interstate healthcare distribution system requires strong, uniform regulatory standards that will facilitate the safe and efficient flow of life-saving medicines to consumers across the United States.

“The current state-by-state licensure is a maze of inconsistencies,” continued Gray. “It should be no surprise that a regulatory system crafted in the 1980s now would face 21st Century challenges that require new and different approaches.”

HDMA has long advocated for a multifaceted approach to address threats to the safety and security of the healthcare system, most notably the threat of counterfeit prescription drugs. This approach must involve all members of the supply chain and include the following: (1) strengthening government regulation, oversight and enforcement; (2) adoption of new technologies; (3) developing and implementing industry best practices.

HDMA says it stands ready to work with government and all supply chain partners to develop and implement uniform approaches to further secure the supply chain to reduce the threat of counterfeit drugs.

In considering how best to make decisions about a national, uniform prescription drug licensing system, HDMA suggests three guiding principles:

■ Any national licensing endeavor must be guided by the priorities of patient safety and supply chain integrity.

■ Supply chain oversight from manufacture to consumption must be based on best practices, including current and promising new technologies such as EPC/RFID.

■ Industry and government must commit to monitor and employ all state-of-the-industry processes and security measures across the system. This cannot be achieved by an individual partner in the supply chain or an individual agency in the government. Consistent and coordinated efforts are needed to continue to improve upon the nation’s high standard of safety.