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FDA Takes Action on Compounding, Including on Both 503A and 503B Compounding

On February 15, 2019, the Federal Food and Drug Administration (FDA) issued a final rule specific to section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) regarding the list of bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act. The rule becomes effective March 21, 2019.  Under Section 503A of the FD&C Act in order to...

503A Compounding Alert: FDA Issues a Newly Revised Draft MOU

Earlier this year, the U.S. Food and Drug Administration (FDA) released its 2018 Compounding Policy Priorities Plan, aimed at providing an overview of the key priorities the FDA sought to pursue in its continued implementation of the federal law surrounding compounding. One of the FDA’s action items in the Compounding Priorities Plan was to revise the Memorandum of Understanding (MOU) policy that was initially drafted by the FDA in 1999...

503A and 503B COMPOUNDING ALERT: FDA Issues a Series of Compounding Updates

In keeping in line with its 2018 Compounding Policy Priorities Plan, the Federal Food and Drug Administration (FDA) released four compounding updates on Monday, July 23rd, including: Compounding risk alert regarding the bulk drug substance, cesium chloride Two new research collaborations with the FDA and the University of Maryland and John Hopkins University in order for the FDA to gather information to help construct the list of bulk drug substances...

Pharmacies and Manufacturers: Patient Assistance Programs and Charities May Be Putting Your Business at Risk as Government Scrutiny Continues

Jazz Pharmaceuticals recently reported in its U.S. Securities and Exchange Commission filing that it has agreed to pay $57 million dollars to the U.S. Department of Justice (DOJ) in order to resolve an investigation by the DOJ that has looked into its financial support of nonprofit patient assistance charities/programs that help Medicare patients cover out-of-pocket drug costs. This investigation was initiated by subpoenas from the U.S. Attorney's Office for Massachusetts...

Unique Issues and Challenges for Supermarket Specialty Pharmacies

Supermarket pharmacies have existed in the marketplace for nearly 60 years, with the number of outlets exploding in more recent times. Supermarket pharmacies have consistently averaged some of the highest customer-satisfaction scores among different pharmacy provider sites, resulting in over 15% of all prescriptions being dispensed from supermarket pharmacies. Over the last several years, with the increased importance and prevalence of specialty medications in the healthcare continuum, many supermarket pharmacies...