On June 1, 2019, the United States Pharmacopeia (“USP”) published the final revisions to its pharmaceutical sterile compounding standards (“chapter <797>”). Chapter <797> sets forth standards for the preparation of compounded...more
The regulation of pharmacies at the state level might not be what Justice Louis Brandeis had in mind as an example of a “laboratory of democracy,” but for pharmacists and consumers, state-level policy-making can have...more
On Wednesday, the Department of Health and Human Services (“HHS”) reversed course in its delay of implementing fines against drug manufacturers that intentionally overcharge 340B providers. In a notice of proposed rulemaking,...more
On September 10, 2018, the federal Food & Drug Administration (”FDA”) released its revised draft standard Memorandum of Understanding (“MOU”) between states and the FDA addressing the interstate distribution of compounded...more