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New England Journal of Medicine, 385 (13), 12651274

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Additionally, the government did not intervene in the action. BPI also told Hunterbrook Media that it is a FDA registered complex generic and NDA drug manufacturer and as such all our operations are conducted under the strict standards required by those regulations, including the Current Good Manufacturing PracticeGuidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act. Compounding pharmacies have for decades provided additional supply in shortage and customized dosages that are not available from other manufacturers

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doi: 10.1016/j.phymed.2025.156975 119 DasDBanerjeeAMukherjeeSMajiBK

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