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As described in the CY 2026 OPPS/ASC proposed rule, we proposed to strengthen this requirement, beginning January 1, 2026, by replacing it with an attestation in the MRF, and that attestation would also contain new specifications (compared to existing affirmation requirements)

Purity and Dosage: Third-Party Test Results Confirmed at 95.5% Chromatographic Purity A key technical detail disclosed in the announcement relates to the independently verified purity and dosage of the BPC-157 in each patch

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