Passed by Congress in 1987 and signed into law in 1988, critical portions of the Prescription Drug Marketing Act are still not in effect. Specifically, those parts that deal with certain drug wholesalers maintaining a “pedigree” for the drugs they trade. But the FDA had finally decided after all these years that December 1st of this year would be the magic day.
I discussed some of this back on December 1st when some secondary wholesalers — those that are not “authorized” wholesalers, for whom the strict pedigree provisions don’t apply –had obtained temporary relief in court preventing the PDMA from finally being implemented . This is important because accurately tracking the pedigree (or chain of custody) of a drug is a major way to keep control of the supply chain. This is critical to making sure counterfeit drugs don’t leak into our regular drug channels, and thereby into your local pharmacy.
Now a federal judge has ruled on this in favor of the secondary wholesalers, thereby staying the provisions of the law. Since two blogs have already covered this, I won’t re-invent the wheel and will direct you to them:
Both Juvan’s Health Law Update and Adam Fein’s Drug Channels had long discussions on the issues in their blogs on December 10th.