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References (not an exhaustive list): Chapter 18.64 RCW RCW 18.130.180 Chapter 246-945 WAC: FD&C Act 503A(b)(1)(A)(i)-(iii), (b)(1)(D), (b)(2) Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (fda.gov) Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (fda.gov) Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act | FDA Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (fda.gov) [i] Please note that, at the time of publication, the most recent update from the FDA regarding its policies for compounders as the national GLP-1 supply begins to stabilize were as follows: For semaglutide : [t]he timeframes during which the agency does not intend to take action against compounders for violations of the FD&C Act arising from conditions that depend on semaglutide injection products inclusion on FDAs drug shortage list are: For a state-licensed pharmacy or physician compounding under section 503A of the FD&C Act, until April 22, 2025, or until the date of the district courts decision on the plaintiffs forthcoming preliminary injunction motion in Outsourcing Facilities Association (OFA) v

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