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503A Compounding Pharmacies Limitations on Compounding Copies of Commercial Drugs The SAFE Drugs Act proposes to amend Section 503A of the FDCA to (i) codify the definition of essentially a copy of a commercially available drug product and (ii) prevent compounding pharmacies from compounding more than 20 units per month of any drug that is essentially a copy of a commercially available product unless tailored to an individual patient

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