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FDA Issues New Draft Guidance on Insanitary Conditions; No Intent to Regulate Physician Offices that Mix, Compound, or Repackage Drugs that are Administered or Dispensed to Patients

This week, the FDA issued a revised draft guidance, “Insanitary Conditions at Compounding Facilities,” intended to help compounding facilities identify and remediate insanitary conditions. This guidance is also intended to help state regulatory agencies understand what the FDA considers to be unsanitary conditions that could cause a drug to become contaminated. This guidance updates previous draft guidance and removes a problematic provision that would have considered physicians who mix, compound, or repackage drugs in their offices as compounding pharmacies. FDA now states that it does not intend to take action against a physician who is compounding or repackaging a drug product, provided that such activities occur in the physician’s office where the products are administered or dispensed to his or her own patients.

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