Compounded medications

AN ACT Relating to establishing safety and regulatory 1
requirements for compounded medications; adding a new section to 2
chapter 18.64 RCW; creating new sections; prescribing penalties; and 3
declaring an emergency. 4
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF WASHINGTON:5
NEW SECTION. Sec. 1. (1) The legislature finds that:6
(a) The safety and integrity of compounded medications are 7
paramount to the health and well-being of residents of Washington;8
(b) The federal food and drug administration sets internationally 9
recognized standards for drug approval and regulatory oversight; 10
however, there have been increasing attempts by unscrupulous actors 11
to circumvent these regulations, undermining public trust and patient 12
safety; 13
(c) Foreign entities, including those from countries such as 14
China, have exploited regulatory gaps to introduce inferior or 15
contaminated active pharmaceutical ingredients into the supply chain 16
for medications intended for compounding; 17
(d) Recent cases, such as those involving medications for weight 18
loss, have demonstrated that high demand can lead to the 19
proliferation of use of illicit, substandard, and potentially harmful 20
H-3005.1
HOUSE BILL 2613
State of Washington 69th Legislature 2026 Regular Session
By Representatives Thai, Parshley, Duerr, Santos, Ormsby, and Hill
Read first time 01/21/26. Referred to Committee on Health Care &
Wellness.
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active pharmaceutical ingredients, jeopardizing patient health and 1
safety; 2
(e) While the food and drug administration bears responsibility 3
for enforcing federal laws to protect citizens from misbranded and 4
adulterated pharmaceutical ingredients, enforcement has proven 5
insufficient to curtail the influx of these substances; and6
(f) Even after the federal food and drug administration took some 7
action to curb imports of active pharmaceutical ingredients for 8
weight loss medications from entities that are not compliant with 9
current good manufacturing practice requirements, patients in our 10
state remain at risk of receiving compounded medications containing 11
active pharmaceutical ingredients produced by entities that the food 12
and drug administration found to not be compliant with those 13
requirements, including active pharmaceutical ingredients imported 14
into the United States before the food and drug administration took 15
action. 16
(2) The legislature finds that it is necessary for the state to 17
take action to protect its residents by ensuring that all active 18
pharmaceutical ingredients used in compounding are sourced from 19
reputable, registered, and inspected establishments, and that only 20
pharmaceutical-grade, safe, and pure ingredients are utilized in 21
medications for weight loss. 22
NEW SECTION. Sec. 2. A new section is added to chapter 18.64 23
RCW to read as follows: 24
(1) It is unlawful for any person or entity to engage in the 25
sale, transfer, or distribution of a drug compounded under section 26
503A of the federal food, drug, and cosmetic act, 21 U.S.C. Sec. 27
353a, unless the compounder of the drug: 28
(a) Uses bulk drug substances that: 29
(i) Comply with the standards of an applicable United States 30
pharmacopoeia or national formulary monograph, if a monograph exists, 31
and the United States pharmacopoeia chapter on pharmacy compounding;32
(ii) If a monograph described in (a)(i) of this subsection (1) 33
does not exist, are drug substances that are components of drugs 34
approved by the federal food and drug administration; or35
(iii) If a monograph described in (a)(i) of this subsection (1) 36
does not exist and the drug substance is not a component of a drug 37
approved by the federal food and drug administration, appear on the 38
list developed by the federal food and drug administration pursuant 39
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to section 503A (b)(1)(A)(i)(III) of the federal food, drug, and 1
cosmetic act, 21 U.S.C. Sec. 353a(b)(1)(A)(i)(III);2
(b) Confirms that any bulk drug substance used under subsection 3
(1)(a)(ii) of this section was reviewed as part of a new drug 4
application approved by the federal food and drug administration 5
under section 505 of the federal food, drug, and cosmetic act, 21 6
U.S.C. Sec. 355; 7
(c) Ensures that the bulk drug substance is a pharmaceutical 8
grade product; 9
(d) Verifies that the bulk drug substance is accompanied by a 10
valid certificate of analysis containing all information material to 11
the safety and effectiveness of the drug compounded using the bulk 12
drug substance, including the identity and content of the bulk drug 13
substance, the country where the bulk drug substance was originally 14
manufactured, identification of each impurity by chemical name and 15
amount present, and any additional element that the commission may 16
require by regulation; 17
(e) Conducts and documents quality control testing of the bulk 18
drug substance prior to its use in a compounded drug to confirm:19
(i) The identity and content of the bulk drug substance; and20
(ii) That impurities present are identified, characterized, 21
quantified, and justified given the product and its intended use;22
(f) Obtains proof that the manufacture of the bulk drug substance 23
took place in an establishment that: 24
(i) Is duly registered for the federal food and drug 25
administration under section 510 of the federal food, drug, and 26
cosmetic act, 21 U.S.C. Sec. 360; and 27
(ii) Has undergone an inspection within the last two years by the 28
federal food and drug administration as a human drug establishment 29
and the inspection: 30
(A) Included current good manufacturing practice compliance and 31
covered the relevant bulk drug substance; and 32
(B) Was classified as "voluntary action indicated" or "no action 33
indicated"; and 34
(g) Complies with the federal food, drug, and cosmetic act, 35
including the provisions in section 503A, 21 U.S.C. Sec. 353a.36
(2)(a) Any person or entity engaging in the sale, transfer, or 37
distribution of compounded drugs shall maintain all records related 38
to the acquisition, examination, and testing of the bulk drug 39
substance for not less than two years after the expiration date of 40
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the last lot of drug containing the bulk drug substance and, upon a 1
request by the commission, shall furnish such records within one 2
business day of receiving the request, or within a reasonable time as 3
determined by the commission based on the circumstances of the 4
request. 5
(b) The commission, its duly authorized agent, or a duly 6
authorized agent of a third party approved by the commission, shall 7
have the authority to inspect any person or entity that engages in 8
compounding drugs, as well as any domestic supplier, wholesaler, 9
repackager, or other provider of the bulk drug substance for 10
compounding, for compliance with the requirements in subsection (1) 11
of this section. Refusal to permit the commission, its duly 12
authorized agent, or third party, access to conduct an inspection 13
shall constitute a violation of this section. 14
(3) A violation of this section shall result in:15
(a) A fine of $1,000 per dose of the illegally compounded drug 16
sold, transferred, or distributed; and 17
(b) Revocation of the pharmacy license. 18
(4) The commission may adopt rules to implement this section.19
(5) For the purposes of this section, the terms "bulk drug 20
substance" or "active pharmaceutical ingredient" mean any substance 21
that is intended for incorporation into a finished drug product and 22
is intended to furnish pharmacological activity or other direct 23
effect in the diagnosis, cure, mitigation, treatment, or prevention 24
of disease, or to affect the structure or any function of the body. 25
It does not include intermediates used in the synthesis of the 26
substance. 27
NEW SECTION. Sec. 3. If any part of this act is found to be in 28
conflict with federal requirements that are a prescribed condition to 29
the allocation of federal funds to the state, the conflicting part of 30
this act is inoperative solely to the extent of the conflict and with 31
respect to the agencies directly affected, and this finding does not 32
affect the operation of the remainder of this act in its application 33
to the agencies concerned. Rules adopted under this act must meet 34
federal requirements that are a necessary condition to the receipt of 35
federal funds by the state.36
NEW SECTION. Sec. 4. This act is necessary for the immediate 37
preservation of the public peace, health, or safety, or support of 38
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the state government and its existing public institutions, and takes 1
effect immediately. 2
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