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The FDA recently finalized regulatory guidance for compounded animal medications from bulk drug substances for use in non-food-producing animals, impacting the way compounded drugs can be used, documented, ordered, and prescribed. Pharmacists must document why an FDA-approved or indexed product is not being used to compound the medication.
those sold before January 1, 2021, into three categories: Grandfathered (DIN before August 21, 2019), Line Extension (DIN on or after August 21, 2021 for new dosage form/strength of Grandfathered medicine), and Gap (DIN on or after August 21, 2019 and first sale before January 1, 2021). The PMPRB has now produced revised Draft Guidelines.
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