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Clinical trials stop after a few years, and some of the currently FDA-approved drugs have only been around for a couple of years

But although state boards of pharmacy license and inspect compounding facilities, the FDA inspects only the ones seen as a safety riskmeaning the sector is largely unregulated

Preclinical safety data does not always predict human safety outcomes, and the absence of adverse effects in controlled animal studies does not guarantee the same in diverse human populations with varying health conditions and concurrent medications

Specific host proteins, absent in vitro, may restore or enhance pathogenicity when re-introduced