BILL REQ. #:  S-3543.1 

Read first time 01/09/12.   Referred to Committee on Health & Long-Term Care.

     AN ACT Relating to the donation and redistribution of unused prescription drugs; and adding a new chapter to Title 70 RCW.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF WASHINGTON:

NEW SECTION.  Sec. 1   The definitions in this section apply throughout this chapter unless the context clearly requires otherwise.
     (1) "Department" means the department of health.
     (2) "Donor" means an individual who donates unused prescription drugs to a health care facility or a participating practitioner for the purpose of redistribution to established patients of that health care facility or practitioner.
     (3) "Health care facility" means a hospital, clinic, nursing home, laboratory, office, or similar place where a health care provider provides health care to patients.
     (4) "Participating practitioner" means a licensed health care practitioner who is authorized to prescribe drugs and who registers with the department to participate in the collection of donated drugs, prescribed for use by established patients of that health care practitioner and donated for the purpose of redistribution to established patients of that health care practitioner.
     (5) "Recipient" means an individual who voluntarily receives donated prescription drugs.
     (6) "Tamper-evident" means a device or process that makes unauthorized access to protected pharmaceutical packaging easily detected.

NEW SECTION.  Sec. 2   (1) Unused prescription drugs may be donated to a health care facility or a participating practitioner and a health care facility or a participating practitioner may accept and redistribute the donated prescription drugs in accordance with department rules.
     (2) The department must adopt rules establishing:
     (a) Procedures to allow the donation and redistribution of certain prescription drugs, including refrigerated drugs, that:
     (i) Ensure that the redistribution process is consistent with public health and safety standards; and
     (ii) Exclude controlled substances;
     (b) Standards and procedures for accepting, storing, labeling, and redistributing donated prescription drugs;
     (c) Standards and procedures for inspecting donated prescription drugs to determine that the packaging is tamper-evident and that the donated prescription drugs are unadulterated, safe, and suitable for redistribution;
     (d) A form to be signed by the recipient specifying:
     (i) Knowledge that the donor is not a pharmacist and took reasonable care of the donated prescription drug;
     (ii) Knowledge that the donor is known to the health care facility or the participating practitioner and that there is no reason to believe that the donated prescription drug was improperly handled or stored;
     (iii) That any person who exercises reasonable care in donating, accepting, or redistributing under this section is immune from civil or criminal liability or professional disciplinary action of any kind for any related injury, death, or loss; and
     (iv) That the immunity provided by this section does not decrease or increase the civil or criminal liability of a drug manufacturer, distributor, or dispenser that would have existed but for the donation;
     (e) A form to be signed by the donor verifying that:
     (i) The donated prescription drug has been properly stored and the container has not been opened or tampered with;
     (ii) The donated prescription drug has not been adulterated or misbranded; and
     (iii) The donor is voluntarily donating the prescription drug;
     (f) A handling fee not to exceed twenty dollars that may be charged to the recipient by the facility or the participating practitioner to cover the costs of inspecting, storing, labeling, and redistributing the donated prescription drug; and
     (g) Any other standards deemed necessary by the department.
     (3) The department must maintain and publish a current listing of participating health care facilities and participating practitioners.

NEW SECTION.  Sec. 3   Before redistributing donated prescription drugs, a health care facility or participating practitioner must:
     (1) Comply with all applicable federal and state laws that deal with the inspection, storage, labeling, and redistribution of donated prescription drugs; and
     (2) Examine the donated prescription drug to determine that it has not been adulterated or misbranded and certify that the drug has been stored in compliance with the requirements of the product label.

NEW SECTION.  Sec. 4   (1) Any person who exercises reasonable care in donating, accepting, or redistributing prescription drugs pursuant to this section is immune from civil or criminal liability or professional disciplinary action of any kind for any related injury, death, or loss.
     (2) The immunity provided by this section does not decrease or increase the civil or criminal liability of a drug manufacturer, distributor, or dispenser that would have existed but for the donation.
     (3) A manufacturer is not liable for failure to transfer or communicate product consumer information or the expiration date of the donated prescription drug under this section.
     (4) This section does not restrict the authority of the state to regulate or ban the use of any prescription drugs.

NEW SECTION.  Sec. 5   Sections 1 through 4 of this act constitute a new chapter in Title 70 RCW.