Earlier this summer, the U.S. Food and Drug Administration (“FDA”) issued a notice, as required by federal law, that describes the agency’s intent to conduct research examining “how firms communicate about prescription drugs from the... Read More
In a win for pharmacy in the decade long squirmish between FDA and compounding pharmacies, FDA has been ordered to conduct a review of its MOU. The MOU establishes an understanding between individual State Boards of Pharmacy and the FDA involving... Read More
As we approach the 10 year anniversary of enactment of the DSCSA and move toward the final complex interoperable electronic tracking phase, every pharmacist needs to be aware of the effects this legislation has on the pharmaceutical supply chain. ... Read More
On August 9, 2021, the Food and Drug Administration (FDA) announced it would delay enforcement of the 5% limit on out-of-state shipments of compounded prescriptions until October 27, 2022. States that sign the MOU commit to investigating,... Read More
Recently, on July 21, 2021, the U.S. Food and Drug Administration (“Agency” or “FDA”) denied a new dietary ingredient (“NDI”) notification filed by Charlotte’s Web for full spectrum hemp extract containing cannabidiol (“CBD”). ... Read More
On July 9, 2021, President Biden issued an executive order (EO) containing 72 directives to more than a dozen federal agencies, many of which have broad implications for healthcare. Specifically targeted are healthcare competition, hospital mergers,... Read More
PBMs have historically accepted pharmaceutical manufacturer coupons so long as the usage of such coupons complies with both state and federal law. Recently, however, PBMs have begun to allege technical breaches of the contract for a pharmacy’s... Read More
Increasing complexities in the pharmaceutical supply chain have led to challenges in the purchase and distribution of pharmaceutical products directly to medical practices. While the traditional role of MSOs is centralization of administrative and... Read More
The Food and Drug Administration (FDA) continues to recommend additions to the 503(B) Bulks List (https://www.fda.gov/media/94164/download). A component of the Drug Quality and Security Act of 2013, the list includes drug products that 503(B)... Read More
The Department of Justice (“DOJ”) has recently announced that it is ramping up its efforts to prosecute fraud in clinical research trials. To obtain Food and Drug Administration (“FDA”) approval for new drugs and medical devices, it must be... Read More
