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
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Posted: 26 Aug 2018 06:14 PM PDT
By Allyson B. Mullen —
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. |
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 .
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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 ...
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