BILL REQ. #:  S-3841.3 

READ FIRST TIME 01/24/12.   

     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) "Donor" means a person, practitioner, health care facility, or an individual or entity licensed under chapter 18.64 RCW.
     (4) "Health care facility" means a hospital, medical clinic, nursing home, practitioner office, or pharmacy.
     (5) "Hospital" has the meaning provided in RCW 70.41.020.
     (6) "Pharmacy" means every place properly licensed by the board of pharmacy where the practice of pharmacy is conducted.
     (7) "Practitioner" means a health care practitioner defined in RCW 69.41.010 who is authorized to prescribe cancer drugs.
     (8) "Program" means the cancer drug repository program.
     (9) "Single-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 cancer drugs from donors and dispensing donated cancer drugs to Washington residents holding a valid prescription for such drugs. 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 practitioners or pharmacies that accept and distribute or dispense donated cancer drugs. Standards and procedures must require the inspection of donated cancer drugs by the practitioner or pharmacist to determine that the packaging is tamper-evident and that the donated prescription drugs are unadulterated, not misbranded and safe, and suitable for redistribution, including determining that:
     (i) The cancer drug is in its original sealed and tamper-evident unit dose packaging; and
     (ii) In the case of opened packages, that the single-unit dose packaging remains intact;
     (b) Necessary forms for administration of the program, including forms to be completed by donors, and forms for use by practitioners and pharmacies that accept, distribute, or dispense cancer drugs under the program. A person receiving cancer drugs under the program must be provided a form disclosing that the drug was donated;
     (c) The maximum handling fee that may be charged by participating practitioners or pharmacies for distributing or dispensing cancer drugs under the program. Handling fees must be paid by the recipient of the cancer drug and may not be charged, in whole or in part, to any third party;
     (d) Categories of cancer drugs that the program will and will not accept for dispensing; and
     (e) Maintenance and distribution of the participating practitioner or pharmacy registry under section 6 of this act.

NEW SECTION.  Sec. 3   (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 or in single-unit dose packaging if the outside packaging is opened but the single-unit dose packaging is intact.
     (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. 4   (1) Participating practitioners or pharmacies must comply with state and federal laws on storage, distribution, and dispensing of cancer drugs received under the program. Participating practitioners or pharmacies must comply with department rules on inspecting donated prescription drugs. 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 practitioner or pharmacy for dispensing.
     (2) Participating practitioners or pharmacies 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 or charged, in whole or in part, to any third party.

NEW SECTION.  Sec. 5   (1) Any person or entity that donates, accepts, or dispenses prescription drugs under this section shall not, in the absence of negligence, be subject to any of the following for matters related to donating, accepting, or dispensing such prescription drugs: Criminal prosecution, liability in tort or other civil action for injury, death, or loss to person or property, or professional disciplinary action.
     A drug manufacturer shall not, in the absence of 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 related to the donation, acceptance, or dispensing of a drug manufactured by the drug manufacturer that is donated by any person under the program, including liability for failure to transfer or communicate product or consumer information or the expiration date of the donated drug.
     (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. 6   The department must establish and maintain a participating practitioner or pharmacy registry for the program. The participating practitioner or pharmacy registry must include the participating practitioner's or pharmacy's name, address, and telephone number. The participating practitioner or pharmacy registry must be available to any person or entity wishing to donate cancer drugs to the program.

NEW SECTION.  Sec. 7   Sections 1 through 6 of this act constitute a new chapter in Title 70 RCW.