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Similarly, Section 503B does not allow for compounding of drugs that are essentially a copy of one or more approved drugs but the statute notes that this does not apply to drugs on the drug shortage list in effect under Section 506E. The 506E shortage list recognizes drugs that have low availability due to manufacturing or quality problems, delays or discontinuations

A better research question is which pathway, model or documentation standard fits the study objective

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A side-by-side comparison is provided below