The FDA Aims To Strike Balance On Inspecting Physicians Who Compound Drugs
Just how much will the FDA look the other way when it comes to inspecting physician compounders?
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Physicians who compound drugs in their offices for patients will not be inspected as FDA decides to exercise discretion, recent final guidance said.
The US FDA will allow pharmacy compounders to use non-sterile masks and gloves in cleanrooms, but risk strategies must be in place to ensure products are as contaminant-free as possible. Discretion responds to the current shortage of protective gear due to the COVID-19 pandemic.
FDA has announced a multifaceted effort to tackle the oversight of drug compounding facilities this year. On the to do list: setting the groundwork for establishing centers for excellence for outsourcing facilities; finalizing a guidance on identifying insanitary conditions at drug compounding facilities, and finalizing a memorandum of understanding targeting traditional compounders that distribute an “inordinate” amount of their compounded drugs across state lines.