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Regulatory Considerations TB500 is not approved for human use by regulatory agencies in many countries, presenting legal and quality control challenges

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Packaging payment for these drugs and biologicals that appear on a hospital outpatient claim with a primary C-APC service is consistent with our C-APC packaging policy under which we make payment for all items and services, including all non-pass-through drugs, reported on the hospital outpatient claim as being integral, ancillary, supportive, dependent, and adjunctive to the primary service and representing components of a complete comprehensive service, with certain limited exceptions (78 FR 74869)

Researchers isolated a specific fragment and created a stable, synthetic version