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Why isn't Fentanyl either FDA approved or Clia-waived?

There are two types of fentanyl, pharmaceutical fentanyl and illicitly manufactured fentanyl both are considered synthetic opioids. Unfortunately, illicit fentanyl has been found to be commonly laced with other drugs smuggled into the U.S. across it's northern and southern borders. Even recently as the year 2022, sadly there are many stories of not only laced fentanyl but candy colored coatings which can wind up in our children/teens hands and dangerously consumed to the point of death.
Fentanyl is only both Class I and II list of controlled substances. Fentanyl is similar to morphine but about 100 times more potent and it's also 50 times stronger than heroin. For more pertinent resourceful information, please look into one of these resources... csa drug scheduling - rapidexams-kb