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House Passes Stricter Regulations for Compound Pharmacies

Approximately one year removed from the Meningitis tragedy caused by Framingham-based compounder, New England Compounding Center, the Massachusetts House of Representatives has unanimously voted to pass a Bill that requires stricter regulation of compound pharmacies. Some of the new regulations include unannounced inspections of compounders, new reporting requirements, whistleblower protections, additional labeling requirements, continuing education classes for sterile compounders, and increased communication between State and federal regulators regarding any "adverse...

New Georgia Law Requires Licensure of Nonresident Pharmacies

Effective July 1, 2013, Georgia began requiring nonresident pharmacies to obtain licensure through its Board of Pharmacy (BOP). Georgia Code, section 26-4-114.1. The statute requires a nonresident pharmacy permit for “any person, pharmacy, or facility” located outside of Georgia that wants to “ship, mail, or deliver dispensed drugs, including but not limited to dangerous drugs and controlled substances, into this state.” Although the law took effect on July 1, the...

FDA Releases Results of 483 Inspections of Compounders; Contemplating Enforcement Proceedings

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 high-risk sterile drug products in the past posed a significant threat to public health from poor sterile drug production practices. As a result of these inspections, the FDA has issued a list of inspectional...

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...