High Importance!! USP tackles 'hot mess' — veterinary compounding

USP tackles 'hot mess' — veterinary compounding VIN News Service Timeline for U.S. Pharmacopeia recommendations on hazardous drugs and compounded preparations Veterinary compounding in the United States ..

FDA provides scientific and regulatory clarity for generic drug developers through the issuance of 43 new or revised product-specific guidance documents, including hard-to-copy complex generics and abuse-deterrent formulations of opioids

The U.S. Food and Drug Administration today announced a new batch of product-specific guidances to support industry in identifying appropriate science-based methodologies and evidence for developing generic drugs. The batch contains 43 product-specific guidances, including 26 new guidances and 17 revised guidances that, when finalized, will describe the FDA’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to their respective reference-listed drugs.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse

One of the ways that the U.S. Food and Drug Administration is working to address the opioid epidemic is by encouraging the development of opioid analgesic products that are harder to manipulate and abuse. Opioids with abuse-deterrent formulations (ADFs) are intended to make certain types of abuse, such as crushing a tablet to snort or dissolving a capsule to inject, more difficult or less rewarding. 

These innovative formulations are designed to make it harder for people to manipulate the opioid product so they can’t be as easily abused to deliver an immediate “high.” But it’s important that prescribers and patients understand that these drugs are not “abuse-proof,” and they do not prevent addiction, overdose or death.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency’s continued commitment to postmarket review of Essure and keeping women informed

	The U.S. Food and Drug Administration was notified by Bayer that the Essure permanent birth control device will no longer be sold or distributed after December 31, 2018. This decision follows the FDA’s patient safety action in April, in which the agency issued an order restricting the sale and distribution of Essure; it was a unique type of restriction where the FDA used its authority to impose additional requirements to provide a reasonable assurance of the device’s safety and effectiveness. The decision today to halt Essure sales also follows a series of earlier actions that the FDA took to address the reports of serious adverse events associated with its use. Continue reading...

State pharmacy board director allegedly offered job in exchange for controversial medical marijuana rule

State pharmacy board director allegedly offered job in exchange for ...

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State pharmacy board director allegedly offered job in exchange for controversial