Rationale

Guide F3142 will be withdrawn if it is not reapproved. The draft presented here includes minor revisions, shown as redlines, to maintain current references and fix typographical errors. In the time since the last approval of F3142, USP <1001> has been published and provides an in vitro release test that may be used for parenteral drug products, including those with extended periods of drug release such as drug-eluting implants. Guide F3142 provides recommendations specifically for TEMP biomaterial scaffolds that release biomolecules and is therefore distinct from USP <1001> and may also be used to inform the use of USP <1001> to test biomolecule-releasing biomaterial scaffolds.