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As specified in regulations at 419.66(b)(1) through (3), to be eligible for transitional pass-through payment under the OPPS, a device must meet the following criteria: If required by FDA, the device must have received FDA approval or clearance and FDA marketing authorization (except for a device that has received an FDA investigational device exemption (IDE) and has been classified as a Category B device by FDA), or meet another appropriate FDA exemption

The peptide storage guide covers best practices for maintaining potency after reconstitution

Veterinary use formulation with reliable absorption

Inclusion would allow licensed pharmacists and physicians to use them in patient-specific compounded prescriptions

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