Monday, August 27, 2018

The cure that pharmacies have been dreading

The Times-4 hours ago
Little more than a year after Amazon spooked grocers by acquiring Whole Foods, it did the same to pharmacists with its purchase of Pillpack, a mail-orde

John Arnold: Are pharmacy benefit managers the good guys or bad ...

STAT-18 hours ago
n the ongoing debate over drug prices, the pharmaceutical industry has been highly effective in shifting the blame to the middlemen — in particular to pharmacy ..

Fixing the opioid crisis requires the two things Congress hates most ...

NBCNews.com-13 hours ago
We are all now bearing the cost of our collective a

FDA Singles Out Three Drug Substances to Not be Compounded

Regulatory Focus-10 hours ago
Vasopressin, meanwhile, is the active ingredient in Vasostrict, and was the subject of Endo's lawsuit over how the FDA regulates drug compounding.
FDA Says No Need to Compound from Bumetanide, Nicardipine ...
Pharmaceutical Technology Magazine-7 hours ago

Par Wants Bulk Vasopressin Compounding Nixed; FDA Agrees ...

https://www.law360.com/.../articles/.../fda-agrees-to-nix-compounding-of-vasopressin
1 hour ago - Just as Par Pharmaceutical asked a D.C. federal court Monday to enjoin a U.S. Food and Drug Administration policy governing bulk drug compounding, the

Texas Board of Pharmacy Disciplinary Action Summaries and Remedial Plans During August 7, 2018 Meeting

Disciplinary Action Summaries & Remedial Plans


Click here to view the disciplinary action summaries discussed and/or entered at the August 7, 2018 Board Meeting.

Click here to view the remedial plans discussed and/or entered at the August 7, 2018 Board Meeting.

Texas Board of Pharmacy Adopted and Proposed Rules at meeting on August 7, 2018

Several TSBP Board Rules were adopted and proposed during the Board Meeting on August 7, 2018. You may view a summary of the adopted and proposed rules here.
Posted: 26 Aug 2018 06:14 PM PDT
One of the most painful consequences of a bad inspection at a U.S. facility is FDA’s resulting refusal to issue certificates to foreign governments (CFGs) until the issues are resolved. CFGs are quite often a requirement to renew licenses and permits to sell in various foreign markets. Although typically linked to a warning letter, sometimes a Form 483 can trigger this refusal. Sometimes it can take many months, or more than a year, for FDA to begin issuing CFGs again. During that time period, a manufacturer may find itself unable to sell product into certain foreign countries.

High Importance!! PHARMALOT Compounding licenses held by a major wholesaler are suspended in two states By ED SILVERMAN @Pharmalot AUGUST 27, 2018


Compounding licenses held by a major wholesaler are suspended in two states
AmerisourceBergen (ABC 1), which is one of the nation's largest pharmaceutical wholesalers, faces a fresh round of setbacks with its compounding .

US FDA proposes restricting compounding of three drug substances


US FDA proposes restricting compounding of three drug substances
Aug 27 (Reuters) - The U.S. Food and Drug Administration on Monday in a first-of-its-kind action proposed restricting the ability of companies that ...