HB 2613
In CommitteeHouse
Compounded medications
Establishing safety and regulatory requirements for compounded medications.
This status may be delayed. See Action History below for the latest updates.
How does a bill become law?
- Introduced: The bill is filed and assigned a number.
- Committee: A subject-matter committee holds hearings, takes public testimony, and decides whether to advance the bill.
- Floor Vote: The full chamber (House or Senate) debates and votes on the bill.
- Opposite Chamber: The bill repeats the committee and floor vote process in the other chamber.
- Governor: The Governor reviews the bill and decides whether to sign or veto it.
- Signed: The bill has been signed into law.
AI Analysis
This bill strengthens oversight of compounded medications in Washington by requiring pharmacies to use only safe, high-quality active pharmaceutical ingredients sourced from FDA-registered and inspected facilities. It also establishes strict recordkeeping, testing, and verification requirements—and penalties for noncompliance—to protect patients from potentially harmful or illicit ingredients, especially in weight-loss medications.
- Requires pharmacies compounding drugs under federal Section 503A to use only pharmaceutical-grade active pharmaceutical ingredients (APIs) from FDA-registered and recently inspected facilities.
- Mandates that bulk drug substances used in compounding must either meet USP/NF standards, be components of FDA-approved drugs, or be on the FDA’s approved list for compounding.
- Requires certificates of analysis for each bulk drug substance, including details on identity, purity, impurities, and country of manufacture.
- Requires pharmacies to conduct and document quality control testing of bulk drug substances before use.
- Requires pharmacies to maintain records for at least two years after the drug’s expiration and produce them within one business day of a request by the state.
- Authorizes the Washington State Pharmacy Commission to inspect pharmacies and suppliers and imposes penalties of $1,000 per illegal dose and license revocation for violations.
Who is affected
- Pharmacies and compounding pharmacies — Pharmacies and compounding pharmacies must verify sourcing, quality, and safety of active pharmaceutical ingredients used in compounded drugs, maintain detailed records, and may face fines or license revocation for violations.
- Patients receiving compounded medications — Patients who receive compounded medications—especially weight-loss drugs—will benefit from increased assurance that ingredients are safe, pure, and legally sourced.
- Suppliers and manufacturers of active pharmaceutical ingredients — Suppliers, manufacturers, and distributors of active pharmaceutical ingredients used in compounding must be registered with the FDA, undergo recent inspections, and provide certificates of analysis to remain in the supply chain.
- Washington State Pharmacy Commission — The Washington State Pharmacy Commission will gain new inspection and enforcement authority, and may adopt rules to implement the law.
Pro/Con Analysis
Stronger case for benefits
Potential Benefits (5)
Patients receiving compounded medications—particularly weight-loss drugs—will benefit from stronger safeguards against contaminated, substandard, or illicit active pharmaceutical ingredients, directly reducing risk of adverse health events and increasing trust in pharmacy-compounded products.
HealthcarePeopleRef: Sec. 2(1)(d), Sec. 2(1)(e), Sec. 2(1)(f)Requiring FDA-registered and recently inspected facilities for sourcing APIs reduces the risk of importing dangerous or non-compliant ingredients from countries with lax oversight (e.g., China), protecting consumers from harmful or ineffective medications.
Public SafetyPeopleRef: Sec. 2(1)(f)Mandating certificates of analysis and pre-use quality control testing ensures that each batch of bulk drug substance is verified for identity, purity, and impurities—reducing the chance of medication errors or adverse reactions due to contamination or mislabeling.
HealthcarePeopleRef: Sec. 2(1)(c), Sec. 2(1)(d), Sec. 2(1)(e)Two-year record retention and one-business-day production requirement enhances transparency and enables rapid state oversight, supporting quicker identification and containment of unsafe products—benefiting public health surveillance and response.
HealthcarePeopleRef: Sec. 2(2)(a)Strong enforcement mechanisms—including per-dose fines and license revocation—create meaningful deterrence against unsafe or illegal compounding practices, especially targeting the growing black market in weight-loss medications.
Public SafetyLean peopleRef: Sec. 2(3)(a), Sec. 2(3)(b)
Potential Concerns (5)
Pharmacies—especially small, independent compounding pharmacies—may face significant operational and financial burdens verifying supplier inspection status and conducting quality control testing, potentially reducing access to compounded medications in rural or underserved areas where compounding capacity is already limited.
HealthcarePeopleRef: Sec. 2(1)(f)(ii)The requirement to produce records within one business day—and the $1,000-per-dose penalty for violations—creates high legal and compliance risk for pharmacies, potentially forcing closures or reducing services, especially for small operators who lack dedicated compliance staff.
Business & EmploymentPeopleRef: Sec. 2(2)(a) and Sec. 2(3)(a)By restricting bulk drug substances to only those on the FDA’s approved list or meeting USP/NF standards, the bill may limit availability of certain compounded medications (e.g., for weight loss or niche conditions) where FDA-approved alternatives are unavailable or inaccessible, potentially harming patients who rely on customized formulations.
HealthcarePeopleRef: Sec. 2(1)(a)(iii) and Sec. 2(1)(f)Mandatory license revocation for violations—without regard to intent, scale, or harm—could disproportionately impact small pharmacies with isolated compliance lapses, leading to job losses and reduced local pharmacy access.
Business & EmploymentLean peopleRef: Sec. 2(3)(b)The $1,000-per-dose fine could generate state revenue, but the bill does not specify how those funds would be used—potentially diverting resources from public health programs if not earmarked—and may incentivize aggressive enforcement over patient-centered outcomes.
FinancialRef: Sec. 2(3)(a)
Who Is Most Affected
Patients receiving compounded medications—especially weight-loss drugs—will experience significantly improved safety and reliability of medications, with reduced risk of adverse events from contaminated or substandard ingredients.
Small and independent compounding pharmacies will face steep compliance costs (testing, recordkeeping, sourcing verification), potentially reducing their ability to operate—especially in rural areas—while larger chains may absorb costs more easily.
Suppliers and manufacturers must now meet FDA registration and inspection standards and provide certificates of analysis—raising barriers to entry for foreign or unregulated suppliers but creating more stable, transparent supply chains for compliant vendors.
The Pharmacy Commission gains new inspection and enforcement authority, increasing its capacity to protect public health—but also faces new resource demands for rulemaking, inspections, and adjudication of violations.
Low-income and rural Washingtonians—especially those relying on compounded weight-loss or hormone therapies—may face reduced access if small compounding pharmacies close due to compliance burdens, even as safety improves for those who can still obtain medications.