Search Results for Difficult-to-Compound

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FDA Appoints Members to New, Influential Advisory Committee By Alexander Gaffney, RAC - Published 16 December 2014

Almost a year after announcing the re-creation of its Pharmacy Compounding Advisory Committee (PCAC), the US Food and Drug Administration (FDA) has announced that it has selected 12 experts who will serve on the influential committee as it considers how best to regulate the pharmaceutical compounding sector.

Categories: News, US, CDER, Drugs

Tags: PCAC, Pharmacy Compounding Advisory Committee, Difficult-to-Compound List, AdComm, Advisory Committee

In FDA Effort to Strengthen Regulation of Compounded Drugs, Protections and Profits Intersect By Alexander Gaffney, RAC - Published 04 September 2014

A new law meant to protect consumers from unsafe pharmaceutical compounding practices is drawing interest from pharmaceutical companies, who are petitioning the US Food and Drug Administration (FDA) to add some of their products to a new list of restricted drugs that could protect patients from deficient drugs—and likely companies from compounded competition as well.

Categories: News, US, CDER, Drugs, Manufacturing, Regulatory strategy

Tags: 503A 503B, Pharmaceutical Compounding, Compounding, DQSA, Drug Quality and Security Act, Difficult-to-Compound List

As Compounding Framework Takes Shape, So Does Influential Advisory Committee By Alexander Gaffney, RAC - Published 10 January 2014

Categories: US, FDA

Tags: Difficult-to-Compound, Pharmaceutical Compounding, Compounding Pharmacy, Compounding

FDA Prepares Compounding Blacklist of Banned Products By Alexander Gaffney, RF News Editor - Published 03 December 2013

Categories: US, FDA

Tags: Difficult-to-Compound, Pharmaceutical Compounding, Compounding Pharmacy, Compounding, Latest News