wa-law.org > bill > 2025-26 > HB 2613 > Original Bill
The legislature finds that:
The safety and integrity of compounded medications are paramount to the health and well-being of residents of Washington;
The federal food and drug administration sets internationally recognized standards for drug approval and regulatory oversight; however, there have been increasing attempts by unscrupulous actors to circumvent these regulations, undermining public trust and patient safety;
Foreign entities, including those from countries such as China, have exploited regulatory gaps to introduce inferior or contaminated active pharmaceutical ingredients into the supply chain for medications intended for compounding;
Recent cases, such as those involving medications for weight loss, have demonstrated that high demand can lead to the proliferation of use of illicit, substandard, and potentially harmful active pharmaceutical ingredients, jeopardizing patient health and safety;
While the food and drug administration bears responsibility for enforcing federal laws to protect citizens from misbranded and adulterated pharmaceutical ingredients, enforcement has proven insufficient to curtail the influx of these substances; and
Even after the federal food and drug administration took some action to curb imports of active pharmaceutical ingredients for weight loss medications from entities that are not compliant with current good manufacturing practice requirements, patients in our state remain at risk of receiving compounded medications containing active pharmaceutical ingredients produced by entities that the food and drug administration found to not be compliant with those requirements, including active pharmaceutical ingredients imported into the United States before the food and drug administration took action.
The legislature finds that it is necessary for the state to take action to protect its residents by ensuring that all active pharmaceutical ingredients used in compounding are sourced from reputable, registered, and inspected establishments, and that only pharmaceutical-grade, safe, and pure ingredients are utilized in medications for weight loss.
It is unlawful for any person or entity to engage in the sale, transfer, or distribution of a drug compounded under section 503A of the federal food, drug, and cosmetic act, 21 U.S.C. Sec. 353a, unless the compounder of the drug:
Uses bulk drug substances that:
Comply with the standards of an applicable United States pharmacopoeia or national formulary monograph, if a monograph exists, and the United States pharmacopoeia chapter on pharmacy compounding;
If a monograph described in (a)(i) of this subsection (1) does not exist, are drug substances that are components of drugs approved by the federal food and drug administration; or
If a monograph described in (a)(i) of this subsection (1) does not exist and the drug substance is not a component of a drug approved by the federal food and drug administration, appear on the list developed by the federal food and drug administration pursuant to section 503A(b)(1)(A)(i)(III) of the federal food, drug, and cosmetic act, 21 U.S.C. Sec. 353a(b)(1)(A)(i)(III);
Confirms that any bulk drug substance used under subsection (1)(a)(ii) of this section was reviewed as part of a new drug application approved by the federal food and drug administration under section 505 of the federal food, drug, and cosmetic act, 21 U.S.C. Sec. 355;
Ensures that the bulk drug substance is a pharmaceutical grade product;
Verifies that the bulk drug substance is accompanied by a valid certificate of analysis containing all information material to the safety and effectiveness of the drug compounded using the bulk drug substance, including the identity and content of the bulk drug substance, the country where the bulk drug substance was originally manufactured, identification of each impurity by chemical name and amount present, and any additional element that the commission may require by regulation;
Conducts and documents quality control testing of the bulk drug substance prior to its use in a compounded drug to confirm:
The identity and content of the bulk drug substance; and
That impurities present are identified, characterized, quantified, and justified given the product and its intended use;
Obtains proof that the manufacture of the bulk drug substance took place in an establishment that:
Is duly registered for the federal food and drug administration under section 510 of the federal food, drug, and cosmetic act, 21 U.S.C. Sec. 360; and
Has undergone an inspection within the last two years by the federal food and drug administration as a human drug establishment and the inspection:
(A) Included current good manufacturing practice compliance and covered the relevant bulk drug substance; and
(B) Was classified as "voluntary action indicated" or "no action indicated"; and
g. Complies with the federal food, drug, and cosmetic act, including the provisions in section 503A, 21 U.S.C. Sec. 353a.
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Any person or entity engaging in the sale, transfer, or distribution of compounded drugs shall maintain all records related to the acquisition, examination, and testing of the bulk drug substance for not less than two years after the expiration date of the last lot of drug containing the bulk drug substance and, upon a request by the commission, shall furnish such records within one business day of receiving the request, or within a reasonable time as determined by the commission based on the circumstances of the request.
The commission, its duly authorized agent, or a duly authorized agent of a third party approved by the commission, shall have the authority to inspect any person or entity that engages in compounding drugs, as well as any domestic supplier, wholesaler, repackager, or other provider of the bulk drug substance for compounding, for compliance with the requirements in subsection (1) of this section. Refusal to permit the commission, its duly authorized agent, or third party, access to conduct an inspection shall constitute a violation of this section.
A violation of this section shall result in:
A fine of $1,000 per dose of the illegally compounded drug sold, transferred, or distributed; and
Revocation of the pharmacy license.
The commission may adopt rules to implement this section.
For the purposes of this section, the terms "bulk drug substance" or "active pharmaceutical ingredient" mean any substance that is intended for incorporation into a finished drug product and is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. It does not include intermediates used in the synthesis of the substance.
If any part of this act is found to be in conflict with federal requirements that are a prescribed condition to the allocation of federal funds to the state, the conflicting part of this act is inoperative solely to the extent of the conflict and with respect to the agencies directly affected, and this finding does not affect the operation of the remainder of this act in its application to the agencies concerned. Rules adopted under this act must meet federal requirements that are a necessary condition to the receipt of federal funds by the state.
This act is necessary for the immediate preservation of the public peace, health, or safety, or support of the state government and its existing public institutions, and takes effect immediately.