This bill creates a new state law by adding a section to chapter 18.64 RCW that establishes safety and regulatory requirements for compounded medications and makes it unlawful to sell, transfer, or distribute a drug compounded under federal section 503A (21 U.S.C. §353a) unless the compounder meets specified requirements. It imposes substantive criteria for allowable bulk drug substances (also called active pharmaceutical ingredients): they must either meet an applicable USP or national formulary monograph and the USP compounding chapter, be components of FDA‑approved drugs (with confirmation they were reviewed in an FDA new drug application under section 505), or appear on an FDA list created under 503A(b)(1)(A)(i)(III). The bill requires bulk drug substances to be pharmaceutical grade, accompanied by a valid certificate of analysis (including identity, content, country of manufacture, impurity identification and amounts, and any additional elements required by the commission), and subject to documented quality control testing to confirm identity, content, and impurity characterization, quantification, and justification for use. The bill adds procedural rules and penalties: it requires proof that the manufacturer was registered with FDA under section 510 and inspected by FDA within the past two years with inspection outcomes of "voluntary action indicated" or "no action indicated" covering the relevant substance; it mandates recordkeeping of acquisition, examination, and testing records for at least two years after the expiration date of the last lot and furnishing those records to the commission within one business day or a reasonable time as determined by the commission; and it authorizes the commission (and its authorized or approved third‑party agents) to inspect compounders and domestic suppliers, with refusal to permit inspection treated as a violation. Violations carry a penalty of $1,000 per dose of the illegally compounded drug sold, transferred, or distributed, and revocation of the pharmacy license. The commission is given rule‑making authority, the act requires compliance with the federal Food, Drug, and Cosmetic Act (including 503A), contains a provision making conflicting parts inoperative to the extent necessary to receive federal funds, and takes effect immediately. The bill defines "bulk drug substance" or "active pharmaceutical ingredient" as any substance intended for incorporation into a finished drug product to furnish pharmacological activity or affect body structure or function, excluding intermediates used in synthesis. The text repeatedly references "the commission" but does not identify which specific state commission is meant in the provided facts, and it does not specify the new section number within chapter 18.64 RCW. The provisions do not include the detailed processes for pharmacy license revocation, the criteria or procedures for approving third‑party inspection agents, the commission's specific regulations beyond the stated certificate of analysis elements, or the standards for determining a "reasonable time" to produce records.

If enacted, compounding pharmacies and the suppliers they buy from would face new, strict safety checks before they can sell compounded drugs: they would have to buy only pharmaceutical‑grade active ingredients that meet USP monographs, are part of FDA‑approved drugs, or appear on a specific FDA list, obtain detailed certificates of analysis, document identity/content/impurity testing, and prove the ingredient maker was FDA‑registered and inspected within the past two years. That will likely raise their costs and administrative work for testing, recordkeeping, and sourcing, reduce options for using foreign or uninspected suppliers, and increase the chance that noncompliance leads to severe penalties (a $1,000 fine per dose and possible pharmacy license revocation), so some compounded products could become harder to obtain or more expensive. The state agency named in the bill would gain inspection and rule‑making power and could require rapid production of records, but the bill leaves key implementation details unclear—such as which specific commission is meant, how license revocations or third‑party inspector approvals will be handled, and what timeline counts as a “reasonable time” for providing records—so how strictly and quickly these changes take effect will depend on rules the commission issues.