Regulations
A radiopharmaceutical lane runs under several regulators at once, and every handoff is a place where responsibility can be assumed by everyone and held by no one. Centragen was built around that problem.
The shipper's papers, marking, labeling and emergency response information under Part 172 have to survive every handoff intact. Each carrier is its own hazmat employer under Subpart H, and each air leg runs under Part 175 and the operator's own hazmat authority.
Packaging and transport under Part 71; the shipper's and receiver's licenses under NRC or Agreement State programs; the receiver's package survey under 10 CFR 20.1906 and its medical-use license under Part 35, which have to match what arrives, when, and in what condition.
Acceptance checks, transport index limits and category restrictions belong to the operator and differ by operator and aircraft. They are confirmed before booking, with the basis in writing, not discovered at the ramp.
Known-shipper and indirect air carrier security programs under 49 CFR Parts 1544 and 1548 govern who may tender cargo for air carriage; FMCSA hazardous materials carrier rules govern the ground legs.
Authority stays where the regulations place it: with
Centragen's job is to make sure every one of them is named on one record, and that the record survives the lane.
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