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Bottom Line As of May 2026: BPC-157 is not formally approved for routine 503A compounding TB-500 is not formally approved for routine 503A compounding Injectable GHK-Cu remains in a gray regulatory area FDA advisory committee meetings are scheduled that could significantly influence future policy Political announcements do not equal FDA approval Many clinics and pharmacies are still operating in a legally uncertain environment This situation may continue to evolve quickly over the next 12–18 months
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In an interview with MSDF she said, “Something that's really important to keep in mind—and this is a good tip for community physicians—if a person is on DMT and thinking about pregnancy, if that person is taking oral contraceptives, it's really important to discontinue the use of oral contraceptive pills and use a different means of birth control, while the person is on DMT, to establish a regular cycle while the person's MS is still covered by the DMT, prior to doing a washout for pregnancy
