However, as a compounding pharmacy, Imprimis is beholden to section 503A of the federal Food, Drug, and Cosmetic Act, which states that it can't compound drugs "that are essentially copies of a commercially available drug product." The only legal exception to 503A would be if a company altered an existing drug for an individual patient to make a "significant difference" for that patient, according to the law.
A classic example of this is if a patient is allergic to milk and the commercially available pill he or she needs has a dairy coating, said Gabrielle Cosel, manager of drug safety for The Pew Charitable Trusts. In that case, a doctor could write a prescription for a non-dairy pill, and a compounding pharmacist could make it.
quoted from and read entire article at http://www.medpagetoday.com/InfectiousDisease/GeneralInfectiousDisease/54334
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