FDA pro­pos­es tight­en­ing re­stric­tions on com­pound­ing three cat­e­gories of drugs

The FDA is propos­ing to tight­en its reg­u­la­tions on com­pound­ing three cat­e­gories of drugs that the agency de­ter­mined are too dif­fi­cult to com­pound, ac­cord­ing to a pro­posed rule pub­lished Tues­day.

The 38-page pro­posed rule would re­strict com­pound­ing for oral sol­id, mod­i­fied-re­lease drugs that em­ploy coat­ed sys­tems, li­po­some drugs, and med­i­cines pro­duced us­ing hot melt ex­tru­sion, a method used to en­hance the sol­u­bil­i­ty of poor­ly wa­ter-sol­u­ble drugs.

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