How the DQSA might affect medical malpractice claims also is unclear. Plaintiffs’ attorneys could potentially use the law to assign greater blame against doctors in injury cases, Mr. Brown said.
"The concern for physicians is that with the growing awareness and concerns about compounding drugs, and the availability of a new federally-regulated source of compounded drugs, if there are tragic events that result from a compounded drug, (it’s possible) plaintiffs would look to doctors as a source of liability in that they should have been more mindful of the source of the drug," he said.
While some of the law’s edges need to be defined, doctors should not wait to research and determine the optimal base for their compounded drugs supply.
"Regardless of where the outsource falls under the law (503A vs, 503B) physicians, like any other purchaser, should carefully evaluate their practices and operations," Mr. Topoleski said.
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