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Tirzepatide FDA Crackdown: Comparison of Patient Access Scenarios Key Takeaways The tirzepatide FDA crackdown was triggered by Eli Lilly's successful challenge to the FDA drug shortage designation in October 2024, not by safety concerns or quality issues with compounded versions

Although some believe it exists in pill form, the truth is that there is currently no FDA-approved oral tirzepatide available

Bodybuilders using these drugs outside approved indications assume off-label risk without clinical oversight, insurance coverage, or adverse event monitoring

Second, Ozempic reduces the amount of glucose produced by your liver