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Under the FDAs Interim Policy on Compounding Using Bulk Drug Substances, the agency has stated that it does not intend to take enforcement action against pharmacies that compound with bulk drug substances listed in Category 1, provided the pharmacy otherwise complies with the conditions of section 503A

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10.1517/14728222.2014.859248 140 LiX.HuangY.ZhengL.LiuH.NiuX.HuangJ.et al (2014b)