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Regulatory experts familiar with FDA compounding law, including those who interpret 503A bulk drug substance policy, have expressed significant skepticism about this argument

The threshold increase is precautionary

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The compound does not have a Drug Identification Number, Natural Product Number, or Homeopathic Drug Number, and Health Canada has named BPC-157 explicitly in seizure advisories targeting unauthorized injectable peptide vendors operating in Canada since 2023

The amount of water to mix with peptides depends on the desired concentration