Fusion IV Pharmaceuticals, Inc., dba Axia Pharmaceutical, et al. v. Anne Sodergren

Whether 21 U.S.C. §353b of the Federal Food, Drug and Cosmetic Act “FDCA” (the “Compounding Quality Act” which is part of the “Drug Quality and Security Act”), enacted in 2013 which itself “created” federal outsourcing facilities and provided for their oversight by the federal government, preempts California state law licensing requirements contained in Business and Professions Code §4129 and §4129.1, which attempt to require licensing and regulation by the state of California? Whether 21 U.S.C. §353b of the FDCA preempts California state laws and regulations (Business and Professions Code §4129 and §4129.1) in addition to licensing requirements for federal outsourcing facilities? W het her Ca l i for n i a l aw i mp osi ng l icen si ng requirements and regulations (Business and Professions Code §4129 and §4129.1) violates the United States Commerce Clause in light of 21 U.S.C. §353b of the FDCA, the purpose of which was to create and provide oversight of federal outsourcing facilities which are the sole means of placing compounded medications and drugs into interstate commerce in the case of a shortage or in the case of a clinical necessity? Whether the FDCA’s preemption of enforcement (21 U.S.C. §337) of federal outsourcing facilities created under 21 U.S.C. §353b, extends to and thus preempts state laws which require additional licensing and/or regulation of federal outsourcing facilities?