The FDA has released an announcement regarding its recent inspections of 31 sterile compounding pharmacies across the United States. The purpose of these inspections was to determine whether certain pharmacies that were known to have produced... Read More
Every compound pharmacy should be preparing for the passage of new Federal and State laws and regulations addressed specifically to compounding. This article focuses on anticipated Federal legislation. Expect a State law update soon. The strongest... Read More
I wanted to make sure you were aware that the Washington Post article which appeared on Friday alleging that IACP is now supporting FDA oversight of compounding pharmacy is neither accurate nor reflective of the complete story. In fact, IACP and... Read More
Last week, the U.S. Court of Appeals for Second Circuit ruled that the Food and Drug Administration (FDA) cannot prosecute pharmaceutical manufacturers’ representatives for speech promoting the lawful, off-label use of an FDA-approved drug. The... Read More
Over the past few months, we have seen an aggressive trend of Express Scripts, Inc. (“ESI”) and Medco Health Solutions, Inc. (“Medco”) audits, focusing specifically on NDC numbers ending in “00”. Only one manufacturer uses NDC numbers... Read More
For decades there has been an unanswered question hanging over compounding pharmacies and, for that matter, federal regulators: are compounded prescriptions subject to the "new drug" requirements of the federal Food, Drug and Cosmetic Act (FDCA)?... Read More
The fallout from the NECC-Meningitis compounding tragedy has prompted New Jersey lawmakers to require New Jersey compound pharmacies to be “accredited.” On October 15, 2012, New Jersey Assemblyman, Sean Kean, introduced legislation (A3395) that... Read More
On September 19, 2012, the Governor signed into law the New Jersey Revised Uniform Limited Liability Company Act (the "RULLA"). RULLA replaces the current NJ LLC Act, making substantial changes to the laws governing limited liability companies... Read More
The Pennsylvania General Assembly has just passed Senate Bill 201, which prohibits mandatory mail order pharmacy by health insurers and their agents. While it represents a compromise from the original Bill which greatly favored community pharmacies,... Read More
Compounders already faced attacks from PBM auditing. Now, the tragedy arising from the tainted steroid compounds shipped out of New England Compounding Center (NECC) has brought compounding into the national spotlight. The Centers for Disease... Read More
