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
Friday, December 13, 2013
Fifth Question of the Day December 13, 2013 Which 483 issued by the FDA to a compounding pharmacy was the most shocking and unexpected by the compounding world?
1 comment:
Anonymous
said...
Taken together, the information from all inspections of both pharmacies and laboratories is highly problematic regarding sterility assurance levels for products prescribed for individuals and marketed and sold for population use. Based on the totality of inspection findings, products produced outside GMPs should be assumed to have a higher probability of contamination, and higher risk of causing infection, compared to GMP-produced products that undergo validation for specific intended uses.
1 comment:
Taken together, the information from all inspections of both pharmacies and laboratories is highly problematic regarding sterility assurance levels for products prescribed for individuals and marketed and sold for population use. Based on the totality of inspection findings, products produced outside GMPs should be assumed to have a higher probability of contamination, and higher risk of causing infection, compared to GMP-produced products that undergo validation for specific intended uses.
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