The New Federal Compounding Law | NDNR
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21 hours ago - Compounding Problems for Your Practice and Patients? Mike Corrado. This past November, Congress passed – and the president signed into law – the Drug ...
2 comments:
Under 503A, compounded drugs that meet stipulated conditions are exempt from 3 provisions of the FFDCA, and, they may still be held to other provisions for which they are not exempt. Guidance available here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377052.pdf
If you read most recent FDA warning letters, making drugs under unsanitary conditions can result in adulteration charges, wether or not conditions are being met for new drug, labeling, and GMP requirements. Bird feathers fungus and filth should not make their way into FDA-approved or compounded pharmaceuticals, regardless of whether or not they are intended for sterile administration.
"...GMP requirements" above should read "...GMP requirement exemptions"
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