This article is not intended as legal advice and should not be used as such. When legal questions arise, pharmacists should consult with attorneys familiar with the relevant drug and pharmacy laws.
Ned Milenkovich is chair of the Healthcare Law practice at Much Shelist PC and vice chair of the Illinois State Board of Pharmacy. Contact him at: 312-521-2482 / [email protected]
Massachusetts' Harvard Pilgrim Health Care has instituted a policy shift excluding coverage of prescription drugs compounded for adults. Plaintiffs call this "a callous decision" and "a major blow" to the state's many patients who depend on compounded medications.
In June 2013, the Department of Justice under the Obama administration announced an end to its lawsuits regarding age restrictions on “Plan B One-Step” (levonorgestrel), the morning-after pill. The DOJ decided not to appeal the ruling by Judge Edward Korman of the District Court of Eastern New York.
From a legal and regulatory point of view, the crisis has exposed a void in the world of drug manufacturing versus compounding pharmacy to which few pay attention, although there has been significant litigation in this area even before this latest crisis.