BILL REQ. #:  S-3191.2 

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

     AN ACT Relating to requiring the department of health to establish a cancer drug repository program; 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) "Cancer drug" means a prescription drug used to treat:
     (a) Cancer or its side effects; or
     (b) The side effects of a prescription drug used to treat cancer or its side effects.
     (2) "Department" means the department of health.
     (3) "Health care facility" means a hospital, clinic, nursing home, laboratory, office, pharmacy, or similar place where a health care provider provides health care to patients.
     (4) "Hospital" has the meaning provided in RCW 70.41.020.
     (5) "Participating facility" means a health care facility that voluntarily participates in the cancer drug repository program and accepts donated cancer drugs.
     (6) "Pharmacy" means every place properly licensed by the board of pharmacy where the practice of pharmacy is conducted.
     (7) "Prescribing practitioner" means a health care practitioner authorized to prescribe cancer drugs.
     (8) "Program" means the cancer drug repository program.
     (9) "Singe-unit dose packaging" means a single-unit container for articles intended for administration as a single dose, direct from the container.
     (10) "Tamper-evident unit dose packaging" means a container within which a drug is sealed so that the contents cannot be opened without obvious destruction of the seal.

NEW SECTION.  Sec. 2    (1) The department must establish a cancer drug repository program for accepting donated cancer drugs and dispensing such drugs to authorized Washington residents. Participation in the program is voluntary.
     (2) The department, in consultation with the board of pharmacy, must adopt rules to carry out this chapter, including:
     (a) Eligibility criteria and other standards and procedures for participating facilities that accept and distribute or dispense donated cancer drugs;
     (b) Necessary forms for administration of the program, including forms for use by persons or entities that donate, accept, distribute, or dispense cancer drugs under the program;
     (c) The maximum handling fee that may be charged by participating facilities for distributing or dispensing cancer drugs under the program;
     (d) Categories of cancer drugs that the program will and will not accept for dispensing; and
     (e) Maintenance and distribution of the participating facility registry under section 7 of this act.

NEW SECTION.  Sec. 3   Any person or entity including, but not limited to, a cancer drug manufacturer or health care facility, may donate cancer drugs to the program.

NEW SECTION.  Sec. 4   (1) A cancer drug may only be donated to, accepted by, or dispensed under the program if it is in unopened, sealed, and tamper-evident unit dose packaging. A cancer drug packaged in single-unit dose packaging may be donated, accepted, or dispensed if the outside packaging is opened but the single-unit-dose packaging is unopened.
     (2) A cancer drug may not be donated to, accepted by, or dispensed under the program if it:
     (a) Is expired; or
     (b) Is adulterated or misbranded.

NEW SECTION.  Sec. 5   (1) Participating facilities must comply with state and federal laws on storage, distribution, and dispensing of cancer drugs received under the program and must inspect all such drugs before dispensing to determine if they are adulterated or misbranded. Cancer drugs received under the program may only be dispensed pursuant to a prescription issued by a prescribing practitioner or may be distributed to another participating facility for dispensing.
     (2) Participating facilities may charge a handling fee, in accordance with department rule, for distributing or dispensing cancer drugs under the program. Cancer drugs donated under the program may not be resold.

NEW SECTION.  Sec. 6   (1) Except as provided in subsection (2) of this section, any person or entity, including a cancer drug manufacturer, which exercises reasonable care in donating, accepting, distributing, or dispensing cancer drugs under this chapter and rules adopted under this chapter is immune from civil or criminal liability or professional disciplinary action of any kind for any injury, death, or loss to person or property relating to such activities.
     (2) The donation of a cancer drug by a cancer drug manufacturer does not absolve the manufacturer of any criminal or civil liability that would have existed but for the donation, nor shall such donation increase the liability of such cancer drug manufacturer that would have existed but for the donation.

NEW SECTION.  Sec. 7   The department must establish and maintain a participating facility registry for the program. The participating facility registry must include the participating facility's name, address, and telephone number and must identify whether the participating facility is a hospital, clinic, nursing home, laboratory, office, pharmacy, or other similar facility. The participating facility registry must be available to any person or entity wishing to donate cancer drugs to the program.

NEW SECTION.  Sec. 8   Sections 1 through 7 of this act constitute a new chapter in Title 70 RCW.