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Re:Biohackers take aim at big pharma’s stranglehold on insulin by kortex on Monday June 28, 2021 @08:30PM (#27670152)
The FDA won't let anything be released to consumers that does not pass their review of the batch record. The whole point of the BR is it's the recipe in totality of how to correctly (which includes quality) make the drug.

The whole point is to open source the batch record.

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