From U.S. Food & Drug Administration website, published Oct. 6: Compounded drugs can serve an important role for patients whose medical needs cannot be met by a drug approved by the U.S. Food & Drug Administration (FDA). The FDA has revised its draft guidance, proposing a two-part compliance policy.
After considering comments from stakeholders, FDA is revising its draft guidance to, among other things, remove the one-mile radius provision. The new policy describes circumstances under which the FDA generally does not intend to take action against a hospital or health system pharmacy, that is not an outsourcing facility, that compounds and distributes a drug without first receiving a valid prescription or order for an individual patient. These circumstances include that compounded drugs be administered only to patients within the hospital or health system and the drugs are used or discarded within 24 hours of leaving the pharmacy.
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