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Some peptides can be effective in oral formulations, including GLP-1 and BPC-157, and several other needle-free options are available for some peptides, such as PT-141 nasal spray and patches

Additionally, we reiterate what we stated in the CY 2025 PFS proposed rule (89 FR 61739), and wish to clarify in this final rule, and at 424.24(c)(5) with a minor amendment, that any reference to an order or referral at 424.24(c)(5) cannot be construed to require an order or referral for outpatient physical therapy, occupational therapy, or speech-language pathology services

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The FDA cited insufficient human safety data, potential for immune reactions, and manufacturing impurity concerns as the bases for this classification

This level of dilution makes precise dosing incredibly easy and reduces the margin for error