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
Wednesday, October 8, 2014
FDA cracks down on pharmacies By WEEK Producer October 7, 2014
It is not possible to make inference regarding numbers of death outcomes associated with the use of compounded drugs--the number remains unknown. Because the drugs are not tested, and they are not subject to federal/state tracking and surveillance, errors/adverse events/serious outcomes (including deaths) that are known are considered tip of the iceberg. While compounded drugs are essential for patients who cannot otherwise take FDA-approved medicines, because compounds bypass the approval process, factors influencing safety and efficacy may go unrecognized by pharmacists making the drugs, or physicians prescribing them--both parties may be unaware of risks built in to the customized formula.
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It is not possible to make inference regarding numbers of death outcomes associated with the use of compounded drugs--the number remains unknown. Because the drugs are not tested, and they are not subject to federal/state tracking and surveillance, errors/adverse events/serious outcomes (including deaths) that are known are considered tip of the iceberg. While compounded drugs are essential for patients who cannot otherwise take FDA-approved medicines, because compounds bypass the approval process, factors influencing safety and efficacy may go unrecognized by pharmacists making the drugs, or physicians prescribing them--both parties may be unaware of risks built in to the customized formula.
www.webdc.com/pdfs/deathbymedicine.pdf
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