The FDA Sticks With Plan To Exercise Discretion In Enforcing Physician Compounding
Physicians who compound drugs in their offices for patients will not be inspected as FDA decides to exercise discretion, recent final guidance said.
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Just how much will the FDA look the other way when it comes to inspecting physician compounders?
The US FDA tells manufacturers in two recent warning letters to get to the root cause of contamination problems and take a more proactive approach to cleaning and equipment maintenance.
Commissioner Hahn’s tweet announcing a return to inspections, while not a new policy, may be signal that FDA understands sponsor concerns with the agency’s limited ability to conduct onsite inspections. Effort may be aimed at reassuring industry even as CRLs related to manufacturing increase.