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They fall instead under the general remit of the Human Medicines Regulations 2012, which is why unlicensed injectable preparations cannot lawfully be supplied for human administration regardless of "research use only" labelling [3][4]

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In the CY 2024 OPPS/ASC final rule with comment period (88 FR 81594), we codified the OPPS program payment and cost as required by section 1833(t)(8)(F) of the Act by adding a new paragraph (e) to 419.41, which cross-references the regulations adopted in the CY 2024 PFS final rule ( 410.152(m) and 489.30(b)(6))