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"With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C

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This underscores that these medications require long-term, potentially lifelong use to maintain benefitsa consideration with significant cost and adherence implications

But since the advent of commercial drug manufacturing and the FDAs creation of a strict regulatory process for bringing safe, effective medications to market, compounding has been legally relegated to two scenarios, Robin Feldman, JD, a professor at the University of California College of the Law in San Francisco and an expert on pharmaceutical law, tells SELF