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doi: 10.3390/ijms21051725 [DOI] [PMC free article] [PubMed] [Google Scholar] 32.Ma DL, Chen FQ, Xu WJ, Yue WZ, Yuan G, Yang Y

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5316 would Extend the distribution of unapproved compounded drugs for up to six months after a shortage ends, exposing patients to higher risk even when more tightly regulated FDA-approved alternatives are available, Repeal interstate shipment limits and reporting requirements, eliminating restrictions on the volume of compounded drugs that 503A pharmacies can introduce into interstate commerce, Enable mass manufacturing under the guise of compounding by allowing 503A compounding pharmacies to produce drugs without patient-specific prescriptions, Increase the risk of drug diversion and contamination in the supply chain by removing important labeling requirements for 503B outsourcing facilities, and Allow the use of non-pharmaceutical grade ingredients, including in sterile injectable drugs, which poses a direct threat to patient safety.