Com­pound­ing drugs dur­ing the pan­dem­ic: FDA of­fers pol­i­cy clar­i­fi­ca­tions

In re­sponse to “many emails from stake­hold­ers,” the FDA late Mon­day clar­i­fied a few poli­cies re­lat­ed to drug com­pound­ing, in­clud­ing one on the lim­it on the in­ter­state dis­tri­b­u­tion of com­pound­ed drug prod­ucts for phar­ma­cy com­pounders.

Over­all, FDA said its poli­cies are meant to pro­tect pa­tients from un­safe, in­ef­fec­tive and poor-qual­i­ty com­pound­ed drugs while pre­serv­ing ac­cess for pa­tients.

In one of the up­dates, FDA clar­i­fies that a draft guid­ance has not tak­en ef­fect and will be re­vised. The guid­ance notes that FDA will not take ac­tion against cer­tain en­ti­ties as long as drugs are dis­trib­uted on­ly to health­care fa­cil­i­ties that are owned and con­trolled by the same en­ti­ty that owns and con­trols the hos­pi­tal phar­ma­cy and that are lo­cat­ed with­in a one-mile ra­dius of the com­pound­ing phar­ma­cy.

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