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(2) the buyer will not use, resell, relabel, or redistribute this product for human or animal administration, injection, or any clinical or therapeutic purpose

The claim also needs a clear connection between the security failures and the harm, showing the attack was made more likely or more severe because safeguards were missing or ignored

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It leaves the determination to a qualified healthcare provider reviewing medical history, labs, and treatment goals, and notes the answer may be a combination approach rather than one or the other