Saturday, March 23, 2013

Hamburg Says FDA Needs New Authorities to Regulate Pharmacy Compounding

FDA Must Have New Authorities to Regulate Pharmacy Compounding | FDA Voice:

"In the new framework, FDA believes that certain high-risk sterile compounding facilities should be subject to federal oversight to ensure that the compounding of sterile drug products at those facilities can be done without putting patients at undue risk, including . . .

And for all pharmacy compounding, FDA believes certain basic protections should be in place. These include . . ."

'via Blog this'

New Framework:
  • Require compliance with federal quality standards, appropriate for the compounding of riskier products & exposure of larger numbers of patients,
  • Require federal registration of the compounding facilities that will be subject to federal quality standards so FDA knows where they are and what drug products they are making.
  • Require those higher-risk compounding pharmacies to report to FDA serious adverse reactions to their drugs of which they become aware.
Basic Protections:
  • Grant clear authority to examine a pharmacy’s records to more quickly locate the cause of an outbreak or other violations of the law.
  • Prohibit compounding of the most complex and highest risk products—drugs and biologics that should only be made for patients by an FDA-registered drug manufacturer under an approved new drug application. 
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