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Occasional Collector
Posts: 1
Registered: ‎06-12-2012
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FDA Inspections of Home Infusion Pharmacies

Per the ASHP Daily Briefing, the FDA has been inspecting home infusion pharmacies.  I read this and had a few questions:

 

  • Which standard are they using to evaluate what these pharmacies do? 
  • Are home infusion pharmacies supposed to be USP 797 compliant, or is there a different standard such as in pharmaceutical manufacturing and production?
  • If a home infusion pharmacy solely makes products persuant to a physician's prescription, what is the role of the FDA compared to the state board of pharmacy?
Advisor
Posts: 16
Registered: ‎09-20-2012
0

Re: FDA Inspections of Home Infusion Pharmacies

I have read some of the 483's posted on the FDA website and it looks like the inspectors are using cGMP standards not USP 797.