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Unlike a lot of other vitamins which can be absorbed straight into the bloodstream, B12 relies on binding with a protein called intrinsic factor to do this

Grgic T, Grgic D, Drmic D, et al

8 Peptide handling guidanceReconstitution and cold-chain storage practices for lyophilized research peptides

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Shaking the vial vigorously

As an example, the applicant cited language from the Uretero1 TM decision in which CMS agreed that the device met the criterion for substantial clinical improvement, which stated that while comparative studies between Uretero1 TM and other disposable devices would be helpful, CMS agreed that the evidence demonstrating improved outcomes and reduced patient risk associated with the disposable device in comparison with reusable devices represented substantial clinical improvement (87 FR 71932)