Title 69 — Title 69 FOOD, DRUGS, COSMETICS, AND POISONS
31 chapters · 620 sections in this title.
RCW 69.77.010 Findings—Intent.
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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. Patie…
RCW 69.77.020 Definitions.
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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 simil…
RCW 69.77.030 Eligible patient and treating physician may request investigational product—Manufacturer may make for treatment—Agreement.
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(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 …
RCW 69.77.040 Patient eligibility for access and treatment with investigational product.
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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 im…
RCW 69.77.050 Informed consent.
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(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, …
RCW 69.77.060 Issuer may provide coverage for cost or administration of investigational product—Denial of coverage.
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(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 p…
RCW 69.77.070 Hospitals and health care facilities.
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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 t…
RCW 69.77.080 Private right of action—Unprofessional conduct—Immunity from civil or criminal liability.
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(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 cha…
RCW 69.77.090 Pharmacy quality assurance commission may adopt rules.
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The pharmacy quality assurance commission may adopt rules necessary to implement this chapter.[ 2017 c 212 s 9.]