Compounders

17
Mar

Hand Sanitizer Relief – A Compounders’ Guide to A Safe and  Effective Product

In response to the COVID-19 pandemic, FDA released guidance on March 14, 2020 allowing state licensed pharmacies, compounders, and certain federal facilities (referred to collectively as compounders) to manufacture hand sanitizers. In this guidance, FDA indicated that they are aware of people making their own sanitizers due to the shortage of sanitizers on the market, […]

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01
Oct

Vasopressin Verdict May be Precedent for Drug Companies Seeking to Protect Approved Products

In his article “Endo comes out on top in its fight with FDA and bulk compounder” published in Fierce Pharma (here), Eric Palmer has pointed to a potentially precedent-setting decision that may have further implications for the outsourcing compounding community.  The FDA has a long-standing policy regarding the marketing of unapproved drugs after the first […]

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12
Jun

Could the Compounding Responsibility Move to CDER’s Office of Compliance Signal Increased Enforcement Priorities?

We love reading other regulatory pieces, and particularly liked the one written by Regulatory Focus’ Michael Mezher (here) concerning the “agency plans to “institutionalize” its compounding regulatory program within the center’s Office of Compliance.”  While this may provide a better focus for the FDA to coordinate efforts through CDER resources, it could also mean a […]

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