Concerns over drug counterfeiting and diversion are leading federal and state regulators to propose and implement new and far-reaching requirements. One of the most significant new and emerging requirements, e-pedigree, has the potential to become a very onerous requirement on the medical gas industry.

As counterfeiting of popular and highly profitable drugs continues to escalate, regulators have swung into action. As frequently happens in our industry when government regulators sit down to consider drug regulatory issues, medical gases get lumped in with all other pharmaceuticals. In fairness, it needs to be pointed out that the unique aspects of medical gases are typically not well known at the state regulatory level. Counterfeiting activities are driven by financial gain, and that driver simply does not exist in our industry. When the value of the container holding the medical gas is worth nearly 200 times that of the drug in the container, it is unlikely the drug will be counterfeited. We therefore believe it is entirely appropriate to exempt medical gases from e-pedigree requirements.

At the heart of all current e-pedigree proposals is the implementation of an electronic methodology to track all manufacturing, processing and packaging operations, as well as all changes in ownership of the drug. Each drug container must have an open, interoperable electronic technology capability that will allow all individuals in the supply chain to access this information. Unfortunately, the technology to accomplish this does not yet exist in a reliable format. The two most commonly referenced technologies able to facilitate e-pedigree activities are special high-capacity RFID devices, or 2D barcodes, neither of which are in use in the drug industry today.

Passage of these requirements in our industry will mean that each bulk tank, cargo tanker, microbulk unit, portable liquid cylinder, high pressure cylinder, home unit and dewar will have to have an e-pedigree device permanently affixed. As the medical gas moves from the ASU to tankers, to bulk storage tanks, into cylinders, to home units or to healthcare facilities, each activity performed and transfer of product ownership must be recorded on the e-pedigree device. While all of this documentation may be very useful to hospital pharmacies in ensuring the pills they receive have not been counterfeited in someone’s garage or somewhere overseas, it simply adds cost and complexity to the medical gas supply chain without any value added to either the health care facility or the end-user.

The state of California has been the first one out of the gate in proposing an e-pedigree requirement, and early in 2008 they began to get serious about developing and adopting a set of compliance regulations. Medical gas industry representatives met with the California Board of Pharmacy and presented our case for an exemption from e-pedigree requirements. While we believe we presented a clear-cut case and supporting rationale in support of an exemption, practically every other industry group that does business in the state is also seeking a similar exemption. To stay on top of the issue, CGA has retained a local lobbyist, and initial reports indicate our message has been received. How the issue of an e-pedigree exemption for medical gases in California will ultimately be resolved is still up in the air. However, the one thing that is crystal clear is that without an exemption to these e-pedigree requirements, there will be a significant impact on GAWDA members who will be faced with implementing expensive new technologies and procedures. E-pedigree and its associated costs may also force some manufacturers and distributors to decide to drop out of the medical gas market in California, ultimately affecting the availability of medical gases in the state.

In May of 2008, FDA announced they were also considering proposing a federal requirement for e-pedigree. While this would likely eliminate or coordinate e-pedigree requirements among the states, it creates the burden for our industry to work through the same issues with FDA. This is obviously an issue that industry FDA watchers will be following closely over the coming months.

Gases and Welding Distributors Association
Meet the Author
GAWDA Medical Gases Consultant J. Robert Yeoman is president & CEO of B&R Compliance Associates LLC in Lehigh Valley, Pennsylvania. Members can reach him at (610) 868-7183 and at bob.yeoman@brcompliance.com.