reglab/statecodes huggingface dataset:
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.60 - Over-the-Counter Medications. › 69.60.090 - Implementation of federal system—Termination of state system.

RCW 69.60.090
Implementation of federal system—Termination of state system.
Before January 1, 1994, the commission will consult with the state toxicologist to determine whether the federal government has established a legally enforceable system that is substantially equivalent to the requirements of this chapter that govern the imprinting of solid dosage form over-the-counter medication. To be substantially equivalent, the effective dates for implementation of the federal system for imprinting solid dosage form over-the-counter medication must be the same or earlier than the dates of implementation set out in the state system for imprinting solid dosage form over-the-counter medication. If the commission determines that the federal system for imprinting solid dosage form over-the-counter medication is substantially equivalent to the state system for imprinting solid dosage form over-the-counter medication, this chapter will cease to exist on January 1, 1994. If the commission determines that the federal system is substantially equivalent, except that the federal dates for implementation are later than the Washington state dates, this chapter will cease to exist when the federal system is implemented.
[ 2013 c 19 § 121; 1993 c 135 § 3; 1989 c 247 § 9.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.60 - Over-the-Counter Medications. › 69.60.901 - Effective date—1993 c 135.

RCW 69.60.901
Effective date—1993 c 135.
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 shall take effect immediately [April 30, 1993].
[ 1993 c 135 § 5.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.70 - Access to Prescription Drugs. › 69.70.010 - Definitions.

RCW 69.70.010
Definitions.
The definitions in this section apply throughout this chapter unless the context clearly requires otherwise.
(1) "Department" means the department of health.
(2) "Drug manufacturer" means a facility licensed by the pharmacy quality assurance commission under chapter 18.64 RCW that engages in the manufacture of drugs or devices.
(3) "Drug wholesaler" means a facility licensed by the pharmacy quality assurance commission under chapter 18.64 RCW that buys drugs or devices for resale and distribution to corporations, individuals, or entities other than consumers.
(4) "Medical facility" means a hospital, pharmacy, nursing home, boarding home, adult family home, or medical clinic where the prescription drugs are under the control of a practitioner.
(5) "Person" means an individual, corporation, business trust, estate, trust, partnership, association, joint venture, government, governmental subdivision or agency, or any other legal or commercial entity.
(6) "Pharmacist" means a person licensed by the pharmacy quality assurance commission under chapter 18.64 RCW to practice pharmacy.
(7) "Pharmacy" means a facility licensed by the pharmacy quality assurance commission under chapter 18.64 RCW in which the practice of pharmacy is conducted.
(8) "Practitioner" has the same meaning as in RCW 69.41.010.
(9) "Prescribing practitioner" means a person authorized to issue orders or prescriptions for legend drugs as listed in RCW 69.41.030.
(10) "Prescription drugs" has the same meaning as "legend drugs" as defined in RCW 69.41.010. The term includes cancer drugs and antirejection drugs. The term does not include controlled substances.
(11) "Supplies" means the supplies necessary to administer prescription drugs that are donated under the prescription drug redistribution program.
(12) "Time temperature indicator" means a device or smart label that shows the accumulated time-temperature history of a product by providing a nonreversible, accurate record of temperature exposure through the entire supply chain.
(13) "Uninsured" means a person who:
(a) Does not have private or public health insurance; or
(b) Has health insurance, but the health insurance does not provide coverage for a particular drug that has been prescribed to the person.
[ 2016 c 43 § 1; 2013 c 260 § 1.]
NOTES:
Effective date—2016 c 43: "This act takes effect January 1, 2017." [ 2016 c 43 § 8.]
Short title—2016 c 43: "This act may be known and cited as the cancer can't charitable pharmacy act." [ 2016 c 43 § 7.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.70 - Access to Prescription Drugs. › 69.70.020 - Donations of prescription drugs and supplies—Distribution.

RCW 69.70.020
Donations of prescription drugs and supplies—Distribution.
(1) Any practitioner, pharmacist, medical facility, drug manufacturer, or drug wholesaler may donate prescription drugs and supplies to a pharmacy for redistribution without compensation or the expectation of compensation to individuals who meet the prioritization criteria established in RCW 69.70.040. Donations of prescription drugs and supplies may be made on the premises of a pharmacy that elects to participate in the provisions of this chapter. A pharmacy that receives prescription drugs or supplies may distribute the prescription drugs or supplies to another pharmacy, pharmacist, or prescribing practitioner for use pursuant to the program.
(2) The person to whom a prescription drug was prescribed, or the person's representative, may donate prescription drugs under subsection (1) of this section if, as determined by the professional judgment of a pharmacist, prescription drugs:
(a) Equipped with a time temperature indicator at the point of manufacture were stored under required temperature conditions using the prescription drugs' time temperature indicator information and the person, or the person's representative, has completed and signed a donor form, adopted by the department, to release the prescription drug for distribution under this chapter and certifying that the donated prescription drug has never been opened, used, adulterated, or misbranded; or
(b) Not equipped with a time temperature indicator at the point of manufacture, were properly stored and the person, or the person's representative, has completed and signed a donor form, adopted by the department, to release the prescription drugs for distribution under this chapter and certified that the donated prescription drugs have never been opened, used, adulterated, or misbranded. The donor form must require that the person, or the person's representative, attest that the donated prescription drugs have been stored in a manner and location that adheres to the conditions established by the manufacturer.
[ 2017 c 205 § 1; 2016 c 43 § 2; 2013 c 260 § 2.]
NOTES:
Effective date—2017 c 205: "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 [May 5, 2017]." [ 2017 c 205 § 2.]
Effective date—Short title—2016 c 43: See notes following RCW 69.70.010.
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.70 - Access to Prescription Drugs. › 69.70.030 - Immunity—Eligibility.

RCW 69.70.030
Immunity—Eligibility.
To be eligible for the immunity in RCW 69.70.070, a person distributing donated prescription drugs under this chapter must:
(1) Meet all requirements in RCW 69.70.050 and any applicable rules related to the return or exchange of prescription drugs or supplies adopted by the *board of pharmacy;
(2) Maintain records of any prescription drugs and supplies donated to the pharmacy and subsequently dispensed by the pharmacy; and
(3) Identify itself to the public as participating in this chapter.
[ 2013 c 260 § 3.]
NOTES:
*Reviser's note: Chapter 19, Laws of 2013 changed "state board of pharmacy" to "pharmacy quality assurance commission."
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.70 - Access to Prescription Drugs. › 69.70.040 - Dispensing of donated prescription drugs and supplies—Priority given to individuals who are uninsured.

RCW 69.70.040
Dispensing of donated prescription drugs and supplies—Priority given to individuals who are uninsured.
Pharmacies, pharmacists, and prescribing practitioners that elect to dispense donated prescription drugs and supplies under this chapter shall give priority to individuals who are uninsured. If an uninsured individual has not been identified as in need of available prescription drugs and supplies, those prescription drugs and supplies may be dispensed to other individuals expressing need.
[ 2016 c 43 § 3; 2013 c 260 § 4.]
NOTES:
Effective date—Short title—2016 c 43: See notes following RCW 69.70.010.
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.70 - Access to Prescription Drugs. › 69.70.050 - Acceptance and dispensing of prescription drugs or supplies—Requirements—Recalls—Reselling—Reimbursement, related dispensing fees—Manufacturer registration.

RCW 69.70.050
Acceptance and dispensing of prescription drugs or supplies—Requirements—Recalls—Reselling—Reimbursement, related dispensing fees—Manufacturer registration.
(1) Prescription drugs or supplies may be accepted and dispensed under this chapter if all of the following conditions are met:
(a) The prescription drug is in:
(i) Its original sealed and tamper evident packaging; or
(ii) An opened package if it contains single unit doses that remain intact;
(b) The prescription drug bears an expiration date that is more than six months after the date the prescription drug was donated;
(c) The prescription drug or supplies are inspected before the prescription drug or supplies are dispensed by a pharmacist employed by or under contract with the pharmacy, and the pharmacist determines that the prescription drug or supplies are not adulterated or misbranded;
(d) The prescription drug or supplies are prescribed by a practitioner for use by an eligible individual and are dispensed by a pharmacist; and
(e) Any other safety precautions established by the department have been satisfied.
(2)(a) If a person who donates prescription drugs or supplies to a pharmacy under this chapter receives a notice that the donated prescription drugs or supplies have been recalled, the person shall notify the pharmacy of the recall.
(b) If a pharmacy that receives and distributes donated prescription drugs to another pharmacy, pharmacist, or prescribing practitioner under this chapter receives notice that the donated prescription drugs or supplies have been recalled, the pharmacy shall notify the other pharmacy, pharmacist, or prescribing practitioner of the recall.
(c) If a person collecting or distributing donated prescription drugs or supplies under this chapter receives a recall notice from the drug manufacturer or the federal food and drug administration for donated prescription drugs or supplies, the person shall immediately remove all recalled medications from stock and comply with the instructions in the recall notice.
(3) Prescription drugs and supplies donated under this chapter may not be resold.
(4) Prescription drugs and supplies dispensed under this chapter shall not be eligible for reimbursement of the prescription drug or any related dispensing fees by any public or private health care payer.
(5) A prescription drug that can only be dispensed to a patient registered with the manufacturer of that drug, in accordance with the requirements established by the federal food and drug administration, may not be distributed under the program, unless the patient receiving the prescription drug is registered with the manufacturer at the time the drug is dispensed and the amount dispensed does not exceed the duration of the registration period.
[ 2016 c 43 § 4; 2013 c 260 § 5.]
NOTES:
Effective date—Short title—2016 c 43: See notes following RCW 69.70.010.
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.70 - Access to Prescription Drugs. › 69.70.060 - Form—Department to develop.

RCW 69.70.060
Form—Department to develop.
The department shall develop a form for persons to use when releasing prescription drugs for distribution and certifying the condition of the drugs, as provided in RCW 69.70.020(2).
[ 2016 c 43 § 5; 2013 c 260 § 6.]
NOTES:
Effective date—Short title—2016 c 43: See notes following RCW 69.70.010.
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.70 - Access to Prescription Drugs. › 69.70.070 - Liability.

RCW 69.70.070
Liability.
(1) A drug manufacturer acting in good faith may not, in the absence of a finding of gross negligence, be subject to criminal prosecution or liability in tort or other civil action, for injury, death, or loss to person or property for matters relating to the donation, acceptance, or dispensing of any drug manufactured by the drug manufacturer that is donated by any person under the program including, but not limited to:
(a) Liability for failure to transfer or communicate product or consumer information or the expiration date of the donated prescription drug; and
(b) Liability related to prescription drugs that can only be dispensed to a patient registered with the manufacturer of that drug, in accordance with the requirements established by the federal food and drug administration.
(2) Any person or entity, other than a drug manufacturer subject to subsection (1) of this section, acting in good faith in donating, accepting, or distributing prescription drugs under this chapter is immune from criminal prosecution, professional discipline, or civil liability of any kind for any injury, death, or loss to any person or property relating to such activities other than acts or omissions constituting gross negligence or willful or wanton misconduct.
(3) The immunity provided under subsection (1) of this section does not absolve a drug manufacturer of a criminal or civil liability that would have existed but for the donation, nor does such donation increase the liability of the drug manufacturer in such an action.
[ 2016 c 43 § 6; 2013 c 260 § 7.]
NOTES:
Effective date—Short title—2016 c 43: See notes following RCW 69.70.010.
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.70 - Access to Prescription Drugs. › 69.70.080 - Availability of access.

RCW 69.70.080
Availability of access.
Access to prescription drugs and supplies under this chapter is subject to availability. Nothing in this chapter establishes an entitlement to receive prescription drugs and supplies through the program.
[ 2013 c 260 § 8.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.70 - Access to Prescription Drugs. › 69.70.090 - Samples.

RCW 69.70.090
Samples.
Nothing in this chapter restricts the use of samples by a practitioner during the course of the practitioner's duties at a medical facility or pharmacy.
[ 2013 c 260 § 9.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.70 - Access to Prescription Drugs. › 69.70.100 - Resale of prescription drugs not authorized.

RCW 69.70.100
Resale of prescription drugs not authorized.
Nothing in this chapter authorizes the resale of prescription drugs by any person.
[ 2013 c 260 § 10.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.70 - Access to Prescription Drugs. › 69.70.110 - Prescription drug donation—Rules.

RCW 69.70.110
Prescription drug donation—Rules.
The pharmacy quality assurance commission may adopt rules to allow the safe donation of prescription drugs under this chapter including, but not limited to, allowing pharmacy to pharmacy donation of unexpired prescription drug stock.
[ 2020 c 264 § 2.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.75 - Dextromethorphan. › 69.75.010 - Definitions.

RCW 69.75.010
Definitions.
The definitions in this section apply throughout this chapter unless the context clearly requires otherwise.
(1) "Common carrier" means any person who holds himself or herself out to the general public as a provider for hire of the transportation by water, land, or air of merchandise, whether or not the person actually operates the vessel, vehicle, or aircraft by which the transportation is provided, between a port or place and a port or place in the United States.
(2) "Finished drug product" means a drug legally marketed under the federal food, drug, and cosmetic act, 21 U.S.C. 321 et seq., that is in finished dosage form.
(3) "Proof of age" means any document issued by a governmental agency that contains a description or photograph of the person and gives the person's date of birth, including a passport, military identification card, or driver's license.
(4) "Unfinished dextromethorphan" means dextromethorphan in any form, compound, mixture, or preparation that is not a drug in finished dosage form.
[ 2014 c 64 § 1.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.75 - Dextromethorphan. › 69.75.020 - Retail sales—Proof of age from purchaser—Unlawful acts, exceptions—Penalties.

RCW 69.75.020
Retail sales—Proof of age from purchaser—Unlawful acts, exceptions—Penalties.
(1) A person making a retail sale of a finished drug product containing any quantity of dextromethorphan must require and obtain proof of age from the purchaser before completing the sale, unless from the purchaser's outward appearance the person making the sale would reasonably presume the purchaser to be twenty-five years of age or older.
(2) It is unlawful for any:
(a) Commercial entity to knowingly or willfully sell or trade a finished drug product containing any quantity of dextromethorphan to a person less than eighteen years of age; or
(b) Person who is less than eighteen years of age to purchase a finished drug product containing any quantity of dextromethorphan.
(3) Subsection (2)(a) and (b) of this section do [does] not apply if an individual under eighteen years of age:
(a) Supplies proof at the time of sale that such individual is actively enrolled in the military and presents a valid military identification card; or
(b) Supplies proof of emancipation.
(4)(a) Any manufacturer, distributor, or retailer whose employee or representative, during the course of the employee's or representative's employment or association with that manufacturer, distributor, or retailer sells or trades dextromethorphan in violation of subsection (2)(a) of this section must be given a written warning by a law enforcement agency for the first offense. For any subsequent offense, the manufacturer, distributor, or retailer is guilty of a class 1 civil infraction as provided in RCW 7.80.120, except for any manufacturer, distributor, or retailer who demonstrates a good faith effort to comply with the requirements of this chapter.
(b) Any employee or representative of a manufacturer, distributor, or retailer who, during the course of the employee's or representative's employment or association with that manufacturer, distributor, or retailer sells or trades dextromethorphan in violation of subsection (2)(a) of this section must be given a written warning by a law enforcement agency for the first offense. For any subsequent offense, the employee or representative is guilty of a class 1 civil infraction as provided in RCW 7.80.120.
(c) Any person who purchases dextromethorphan in violation of subsection (2)(b) of this section must be given a written warning by a law enforcement agency for the first offense. For any subsequent offense, the person is guilty of a class 1 civil infraction as provided in RCW 7.80.120.
[ 2014 c 64 § 2.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.75 - Dextromethorphan. › 69.75.030 - List of products containing dextromethorphan, trade association representing manufacturers to supply.

RCW 69.75.030
List of products containing dextromethorphan, trade association representing manufacturers to supply.
The trade association representing manufacturers of dextromethorphan shall supply to the pharmacy quality assurance commission and requesting licensed retailers an initial list of products containing dextromethorphan that its members market. This list shall be updated on an annual basis. The trade association representing manufacturers of dextromethorphan shall make other reasonable efforts to communicate the requirements of chapter 64, Laws of 2014.
[ 2014 c 64 § 3.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.75 - Dextromethorphan. › 69.75.040 - Construction of chapter.

RCW 69.75.040
Construction of chapter.
(1) Nothing in this chapter is construed to impose any compliance requirement on a retail entity other than manually obtaining and verifying proof of age as a condition of sale, including placement of products in a specific place within a store, other restrictions on consumers' direct access to finished drug products, or the maintenance of transaction records.
(2) The provisions of this chapter do not apply to medication containing dextromethorphan that is sold pursuant to a valid prescription.
[ 2014 c 64 § 4.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.75 - Dextromethorphan. › 69.75.050 - Preemption.

RCW 69.75.050
Preemption.
This chapter preempts any ordinance regulating the sale, distribution, receipt, or possession of dextromethorphan enacted by a county, city, town, or other political subdivision of this state, and dextromethorphan is not subject to further regulation by such subdivisions.
[ 2014 c 64 § 5.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.75 - Dextromethorphan. › 69.75.900 - Effective date—2014 c 64.

RCW 69.75.900
Effective date—2014 c 64.
This act takes effect July 1, 2015.
[ 2014 c 64 § 7.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.77 - Investigational Drugs, Biological Products, and Devices. › 69.77.010 - Findings—Intent.

RCW 69.77.010
Findings—Intent.
The legislature finds that the process for approval of investigational drugs, biological products, and devices in the United States protects future patients from premature, ineffective, and unsafe medications and treatments over time, but the process often takes many years. Patients who have a terminal illness do not have the luxury of waiting until an investigational drug, biological product, or device receives final approval from the United States food and drug administration. The legislature further finds that patients who have a terminal illness should be permitted to pursue the preservation of their own lives by accessing available investigational drugs, biological products, and devices. The use of available investigational drugs, biological products, and devices is a decision that should be made by the patient with a terminal illness in consultation with the patient's health care provider so that the decision to use an investigational drug, biological product, or device is made with full awareness of the potential risks, benefits, and consequences to the patient and the patient's family.
The legislature, therefore, intends to allow terminally ill patients to use potentially lifesaving investigational drugs, biological products, and devices.
[ 2017 c 212 § 1.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.77 - Investigational Drugs, Biological Products, and Devices. › 69.77.020 - Definitions.

RCW 69.77.020
Definitions.
The definitions in this section apply throughout this chapter unless the context clearly requires otherwise.
(1) "Eligible patient" means an individual who meets the requirements of RCW 69.77.040.
(2) "Health care facility" means a clinic, nursing home, laboratory, office, or similar place where a health care provider provides health care to patients.
(3) "Hospital" means a health care institution licensed under chapter 70.41, 71.12, or 72.23 RCW.
(4) "Investigational product" means a drug, biological product, or device that has successfully completed phase one and is currently in a subsequent phase of a clinical trial approved by the United States food and drug administration assessing the safety of the drug, biological product, or device under section 505 of the federal food, drug, and cosmetic act, 21 U.S.C. Sec. 355.
(5) "Issuer" means any state purchased health care programs under chapter 41.05 or 74.09 RCW, a disability insurer regulated under chapter 48.20 or 48.21 RCW, a health care service contractor as defined in RCW 48.44.010, or a health maintenance organization as defined in RCW 48.46.020.
(6) "Manufacturer" means a person or other entity engaged in the manufacture or distribution of drugs, biological products, or devices.
(7) "Physician" means a physician licensed under chapter 18.71 RCW or an osteopathic physician and surgeon licensed under chapter 18.57 RCW.
(8) "Serious or immediately life-threatening disease or condition" means a stage of disease in which there is reasonable likelihood that death will occur within six months or in which premature death is likely without early treatment.
[ 2017 c 212 § 2.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.77 - Investigational Drugs, Biological Products, and Devices. › 69.77.030 - Eligible patient and treating physician may request investigational product—Manufacturer may make for treatment—Agreement.

RCW 69.77.030
Eligible patient and treating physician may request investigational product—Manufacturer may make for treatment—Agreement.
(1) An eligible patient and his or her treating physician may request that a manufacturer make an investigational product available for treatment of the patient. The request must include a copy of the written informed consent form described in RCW 69.77.050 and an explanation of why the treating physician believes the investigational product may help the patient.
(2) Upon receipt of the request and the written informed consent form, the manufacturer may, but is not required to, make the investigational product available for treatment of the eligible patient. Prior to making the investigational product available, the manufacturer shall enter into an agreement with the treating physician and the eligible patient providing that the manufacturer will transfer the investigational product to the physician and the physician will use the investigational product to treat the eligible patient.
[ 2017 c 212 § 3.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.77 - Investigational Drugs, Biological Products, and Devices. › 69.77.040 - Patient eligibility for access and treatment with investigational product.

RCW 69.77.040
Patient eligibility for access and treatment with investigational product.
A patient is eligible to request access to and be treated with an investigational product if:
(1) The patient is eighteen years of age or older;
(2) The patient is a resident of this state;
(3) The patient's treating physician attests to the fact that the patient has a serious or immediately life-threatening disease or condition;
(4) The patient acknowledges having been informed by the treating physician of all other treatment options currently approved by the United States food and drug administration;
(5) The patient's treating physician recommends that the patient be treated with an investigational product;
(6) The patient is unable to participate in a clinical trial for the investigational product because the patient's physician has contacted one or more clinical trials or researchers in the physician's practice area and has determined, using the physician's professional judgment, that there are no clinical trials reasonably available for the patient to participate in, that the patient would not qualify for a clinical trial, or that delay in waiting to join a clinical trial would risk further harm to the patient; and
(7) In accordance with RCW 69.77.050, the patient has provided written informed consent for the use of the investigational product, or, if the patient lacks the capacity to consent, the patient's legally authorized representative has provided written informed consent on behalf of the patient.
[ 2017 c 212 § 4.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.77 - Investigational Drugs, Biological Products, and Devices. › 69.77.050 - Informed consent.

RCW 69.77.050
Informed consent.
(1) Prior to treatment of the eligible patient with an investigational product, the treating physician shall obtain written informed consent, consistent with the requirements of RCW 7.70.060(1), and signed by the eligible patient or, if the patient lacks the capacity to consent, his or her legally authorized representative.
(2) Information provided in order to obtain the informed consent must, to the extent possible, include the following:
(a) That the patient has been diagnosed with a serious or immediately life-threatening disease or condition and explains the currently approved products and treatments for the disease or condition from which the eligible patient suffers;
(b) That all currently approved and conventionally recognized treatments are unlikely to prolong the eligible patient's life;
(c) Clear identification of the investigational product that the eligible patient seeks to use;
(d) The potentially best and worst outcomes of using the investigational product and a realistic description of the most likely outcome. This description must include the possibility that new, unanticipated, different, or worse symptoms may result and that death could be hastened by the proposed treatment. The description must be based on the physician's knowledge of the proposed treatment in conjunction with an awareness of the eligible patient's condition;
(e) That the eligible patient's health benefit plan is not obligated to pay for the investigational product or any harm caused to the eligible patient by the investigational product, unless otherwise specifically required to do so by law or contract, and that in order to receive the investigational product the patient may be required to pay the costs of administering the investigational product; and
(f) That the eligible patient is liable for all expenses consequent to the use of the investigational product, except as otherwise provided in the eligible patient's health benefit plan or a contract between the eligible patient and the manufacturer of the investigational product.
(3) The document must be signed and dated by the eligible patient's treating physician and witnessed in writing by at least one adult.
[ 2017 c 212 § 5.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.77 - Investigational Drugs, Biological Products, and Devices. › 69.77.060 - Issuer may provide coverage for cost or administration of investigational product—Denial of coverage.

RCW 69.77.060
Issuer may provide coverage for cost or administration of investigational product—Denial of coverage.
(1) An issuer may, but is not required to, provide coverage for the cost or the administration of an investigational product provided to an eligible patient pursuant to this chapter.
(2)(a) An issuer may deny coverage to an eligible patient who is treated with an investigational product for harm to the eligible patient caused by the investigational product and is not required to cover the costs associated with receiving the investigational product or the costs demonstrated to be associated with an adverse effect that is a result of receiving the investigational product.
(b) Except as stated in (a) of this subsection, an issuer may not deny coverage to an eligible patient for: (i) The eligible patient's serious or immediately life-threatening disease or condition; (ii) benefits that accrued before the day on which the eligible patient was treated with an investigational product; or (iii) palliative or hospice care for an eligible patient who was previously treated with an investigational product but who is no longer being treated with an investigational product.
[ 2017 c 212 § 6.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.77 - Investigational Drugs, Biological Products, and Devices. › 69.77.070 - Hospitals and health care facilities.

RCW 69.77.070
Hospitals and health care facilities.
A hospital or health care facility:
(1) May, but is not required to, allow a health care practitioner who is privileged to practice or who is employed at the hospital or health care facility to treat, administer, or provide an investigational product to an eligible patient under this chapter;
(2) May establish a policy regarding treating, administering, or providing investigational products under this chapter; and
(3) Is not obligated to pay for the investigational product or any harm caused to the eligible patient by the product, or any care that is necessary as a result of the use of the investigational product, including under chapter 70.170 RCW.
[ 2017 c 212 § 7.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.77 - Investigational Drugs, Biological Products, and Devices. › 69.77.080 - Private right of action—Unprofessional conduct—Immunity from civil or criminal liability.

RCW 69.77.080
Private right of action—Unprofessional conduct—Immunity from civil or criminal liability.
(1) Chapter 212, Laws of 2017 does not create a private right of action.
(2) A health care practitioner does not commit unprofessional conduct under RCW 18.130.180 and does not violate the applicable standard of care by:
(a) Obtaining an investigational product pursuant to this chapter;
(b) Refusing to recommend, request, prescribe, or otherwise provide an investigational product pursuant to this chapter;
(c) Administering an investigational product to an eligible patient pursuant to this chapter; or
(d) Treating an eligible patient with an investigational product pursuant to this chapter.
(3) The following persons and entities are immune from civil or criminal liability and administrative actions arising out of treatment of an eligible patient with an investigational product, other than acts or omissions constituting gross negligence or willful or wanton misconduct:
(a) A health care practitioner who recommends or requests an investigational product for an eligible patient in compliance with this chapter;
(b) A health care practitioner who refuses to recommend or request an investigational product for a patient seeking access to an investigational product;
(c) A manufacturer that provides an investigational product to a health care practitioner in compliance with this chapter;
(d) A hospital or health care facility where an investigational product is either administered or provided to an eligible patient in compliance with this chapter; and
(e) A hospital or health care facility that does not allow a health care practitioner to provide treatment with an investigational product or enforces a policy it has adopted regarding treating, administering, or providing care with an investigational product.
[ 2017 c 212 § 8.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.77 - Investigational Drugs, Biological Products, and Devices. › 69.77.090 - Pharmacy quality assurance commission may adopt rules.

RCW 69.77.090
Pharmacy quality assurance commission may adopt rules.
The pharmacy quality assurance commission may adopt rules necessary to implement this chapter.
[ 2017 c 212 § 9.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.78 - Diversity in Clinical Trials. › 69.78.010 - Finding—Policy.

RCW 69.78.010
Finding—Policy.
(1) The legislature finds that controlled clinical trials provide a critical base of evidence for evaluating whether a medical product is safe and effective before the product is approved for marketing. The United States food and drug administration has evaluated demographic profiles of people participating in clinical trials for approved drugs and found that some groups, especially ethnic and racial groups, are not always well represented in clinical trials. Diversity in clinical trials is necessary to effectively determine how race, gender, and age impact how a person metabolizes a drug. Communities of color have been working diligently to establish a foundation of trust with government and clinical research with the goal of engaging more trial participants who are members of underrepresented demographic groups. Joining clinical trials is a difficult and complex process and the lack of trust and awareness of clinical trials and research, in addition to burdens related to transportation, geography, and access, limit trial participants. The lack of diversity in clinical trials compounds access to treatment disparities and limits our understanding of the impacts of studied interventions and conditions across the population.
(2) Therefore, it is the policy of the state to:
(a) Improve the completeness and quality of data concerning diverse demographic groups that is collected, reported, and analyzed for the purposes of clinical trials of drugs and medical devices;
(b) Identify barriers to participation in clinical trials by persons who are members of demographic groups that are underrepresented in such trials and employ strategies recognized by the United States food and drug administration to encourage greater participation in clinical trials by such persons;
(c) Make data concerning demographic groups that is collected, reported, and analyzed for the purposes of clinical trials more available and transparent; and
(d) Require certain entities conducting clinical trials to offer trial participants information in a language other than English and provide culturally specific recruitment materials alongside general enrollment materials.
[ 2023 c 426 § 1.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.78 - Diversity in Clinical Trials. › 69.78.020 - Definitions.

RCW 69.78.020
Definitions.
The definitions in this section apply throughout this chapter unless the context clearly requires otherwise.
(1) "Washington state review board" or "review board" means the Washington state institutional review board, established pursuant to 45 C.F.R. Part 46, which is the designated institutional review board for the department of social and health services, the department of health, the department of labor and industries, and other state agencies.
(2) "Underrepresented community" or "underrepresented demographic group" means a community or demographic group that is more likely to be historically marginalized and less likely to be included in research and clinical trials represented by race, sex, sexual orientation, socioeconomic status, age, and geographic location.
[ 2023 c 426 § 2.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.78 - Diversity in Clinical Trials. › 69.78.030 - Diversity in clinical trials program.

RCW 69.78.030
Diversity in clinical trials program.
The Washington state review board shall establish a diversity in clinical trials program to encourage participation in clinical trials of drugs and medical devices by persons who are members of demographic groups that are underrepresented in clinical trials. In developing this program, the review board shall compile and share information and resources in an accessible fashion to assist entities in Washington state that conduct clinical trials of drugs and medical devices to increase participation by persons who are members of demographic groups that are underrepresented in clinical trials including, but not limited to:
(1) Information concerning methods for identifying and recruiting persons who are members of underrepresented demographic groups to participate in clinical trials;
(2) Links or copies of outside resources related to increasing participation by members of underrepresented demographic groups in clinical trials provided by community organizations or other interested agencies or parties;
(3) Contact information for community organizations or other appropriate entities which may be able to provide assistance with efforts to increase participation by underrepresented demographic groups in clinical trials; and
(4) Links to websites maintained by medical facilities, health authorities, and other local governmental entities, nonprofit organizations, and scientific investigators and institutions that are performing research relating to drugs or medical devices in this state.
[ 2023 c 426 § 3.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.78 - Diversity in Clinical Trials. › 69.78.040 - Requirements for state entities or hospitals conducting clinical trials.

RCW 69.78.040
Requirements for state entities or hospitals conducting clinical trials.
Any state entity or hospital that receives funding from the national institutes of health to conduct clinical trials of drugs or medical devices shall:
(1) Adopt a policy concerning the identification and recruitment of persons who are members of underrepresented demographic groups to participate in clinical trials. This policy must include requirements that investigators who are conducting clinical trials collaborate with community-based organizations and use methods recognized by the United States food and drug administration to identify and recruit such persons to participate in those clinical trials;
(2) Provide information to trial participants in languages other than English;
(3) Provide translation services or bilingual staff for trial screening;
(4) Provide culturally specific recruitment materials alongside general enrollment materials; and
(5) Provide electronic consent when not prohibited by the granting entity or federal regulations.
[ 2023 c 426 § 4.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.80 - Food Donation and Distribution—Liability. › 69.80.010 - Purpose.

RCW 69.80.010
Purpose.
The purpose of this chapter is to promote the free distribution of food to needy persons, prevent waste of food products, and provide liability protection for persons and organizations donating or distributing such food products.
[ 1983 c 241 § 1.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.80 - Food Donation and Distribution—Liability. › 69.80.020 - Definitions.

RCW 69.80.020
Definitions.
Unless the context clearly requires otherwise, the definitions in this section apply throughout this chapter.
(1) "Distributing organization" means a charitable nonprofit organization under section 501(c) of the federal internal revenue code which distributes food free of charge and includes any nonprofit organization that distributes food free of charge to other nonprofit organizations or to the public.
(2) "Donor" means a person, corporation, association, or other organization which donates food to a distributing organization. "Donor" includes, but is not limited to, farmers, processors, distributors, wholesalers, and retailers of food. "Donor" also includes persons who harvest agricultural crops or perishable foods which have been donated by the owner to a distributing organization.
(3) "Food" means food products for human consumption as defined in RCW 69.04.008.
[ 1983 c 241 § 2.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.80 - Food Donation and Distribution—Liability. › 69.80.040 - Information and referral service for food donation program.

RCW 69.80.040
Information and referral service for food donation program.
The department of agriculture shall maintain an information and referral service for persons and organizations that have notified the department of their desire to participate in the food donation program under this chapter. The department must coordinate with the department of ecology to ensure that the information and referral service required under this section is implemented in a manner consistent with the activities of RCW 70A.207.020 and 70A.205.550.
[ 2022 c 180 § 404; 1983 c 241 § 4.]
NOTES:
Findings—Intent—Scope of authority of chapter 180, Laws of 2022—2022 c 180: See notes following RCW 70A.205.007.
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.80 - Food Donation and Distribution—Liability. › 69.80.050 - Inspection of donated food by state and local agencies—Variance.

RCW 69.80.050
Inspection of donated food by state and local agencies—Variance.
(1) Appropriate state and local agencies are authorized to inspect donated food items for wholesomeness and may establish procedures for the handling of food items.
(2) To facilitate the free distribution of food to needy persons, the local health officer, upon request from either a donor or distributing organization, may grant a variance to chapter 246-215 WAC covering physical facilities, equipment standards, and food source requirements when no known or expected health hazard would exist as a result of the action.
[ 2002 c 217 § 3; 1983 c 241 § 6.]
NOTES:
Effective date—2002 c 217 § 3: "Section 3 of 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 [March 28, 2002]." [ 2002 c 217 § 4.]
Finding—Purpose—2002 c 217: "The legislature finds and declares that the distribution of food by donors to charitable organizations, such as shelters, churches, and fraternal organizations, serving communal meals to needy individuals can be done safely consistent with rules and recommended health and safety guidelines. The establishment of recommended donor guidelines by the department of health can educate the public about the preparation and handling of food donated to charitable organizations for distribution to homeless and other needy people. The purpose of this act is to authorize and facilitate the donation of food to needy persons in accordance with health and safety guidelines and rules, to assure that the donated food will not place needy recipients at risk, and to encourage businesses and individuals to donate surplus food to charitable organizations serving our state's needy population." [ 2002 c 217 § 1.]
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.80 - Food Donation and Distribution—Liability. › 69.80.060 - Safe receipt, preparation, and handling of donated food—Rules—Educational materials.

RCW 69.80.060
Safe receipt, preparation, and handling of donated food—Rules—Educational materials.
(1) No later than December 31, 2004, the state board of health shall promulgate rules for the safe receipt, preparation, and handling by distributing organizations of food accepted from donors in order to facilitate the donation of food, free of charge, and to protect the health and safety of needy people.
(2) No later than December 31, 2004, the department of health, in consultation with the state board of health, shall develop educational materials for donors containing recommended health and safety guidelines for the preparation and handling of food donated to distributing organizations.
[ 2002 c 217 § 2.]
NOTES:
Finding—Purpose—2002 c 217: See note following RCW 69.80.050.
2023 Revised Code of Washington › Title 69 - Food, Drugs, Cosmetics, and Poisons › Chapter 69.80 - Food Donation and Distribution—Liability. › 69.80.900 - Construction.

RCW 69.80.900
Construction.
Nothing in this chapter may be construed to create any liability of, or penalty against a donor or distributing organization except as provided in RCW 69.80.031.
[ 1994 c 299 § 38; 1983 c 241 § 5.]
NOTES:
Intent—Finding—Severability—Conflict with federal requirements—1994 c 299: See notes following RCW 74.12.400.