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Whatever it is, it's not a commercially available drug in this country.
Also the act says that products that are essentially copies of commercially available drugs may not be compounded "regularly or in inordinate amounts."
Section 503A prohibited compounding "regularly or in inordinate amounts" any drugs that were "essentially copies of a commercially available drug product."
In this synthesis, cis- and trans-isomers were separated by crystallization because only the two cis-enantiomers are used in the commercially available drug.
As an example, the major metabolite of the pharmaceutical trimebutine, desmethyltrimebutine (nor-trimebutine), can be efficiently produced by in vitro oxidation of the commercially available drug.
Some firms make large amounts of compounded drugs that are copies or near copies of FDA-approved, commercially available drugs.
As an example, a commercially available drug delivery device using PLGA is Lupron Depot for the treatment of advanced prostate cancer.