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Compounding and the FDA

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)? The answer has emerged recently in some federal court decisions and that answer is: yes, but . . . (and the "but" is a big one, as this article explains). Some background is helpful....

New Jersey Bill Would Require Compounders to Become PCAB-Accredited

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 would require compounding pharmacies in New Jersey to be accredited by the Pharmacy Compounding Accreditation Board (PCAB). The Bill expressly applies not only to in-state compounders, but also to out-of-state pharmacies that ship compounds into New...

New Jersey Has Revamped the LLC Law: Is Your New Jersey LLC Ready for the Changes?

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 (“LLCs”) in New Jersey. These changes will have a substantial effect on all NJ LLCs and their members. In order to avoid the pitfalls and dangers, your NJ LLC must be aware of...

Pennsylvania Passes Senate Bill 201, Aimed at Stopping Mandatory Mail Order

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, this Bill nonetheless represents a large stride for PA retail pharmacies and endows them with new rights and opportunities against the Pharmacy Benefits Managers (PBMs). Specifically, the Bill provides that "a health insurance policy...

Top 5 Steps All Compound Pharmacies Should Take in Light of the Fungal Meningitis Outbreak

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 Control (CDC) reported this week the fourteenth death from fungal meningitis resulting from the tainted steroid. The CDC has reported over 100 cases of infection from the contaminated epidural steroids, across eleven states. Compounders can anticipate...