FINAL BILL REPORT
This analysis was prepared by non-partisan legislative staff for the use of legislative members in their deliberations. This analysis is not a part of the legislation nor does it constitute a statement of legislative intent.
C 43 L 16
Synopsis as Enacted
Brief Description: Concerning participation in the prescription drug donation program.
Sponsors: House Committee on Health Care & Wellness (originally sponsored by Representatives Parker, Cody, Riccelli, Holy and Tharinger).
House Committee on Health Care & Wellness
Senate Committee on Health Care
Except in limited situations, the Pharmacy Quality Assurance Commission prohibits pharmacists from accepting drugs and supplies for return or exchange after they have been removed from the premises where they were sold, distributed, or dispensed. An exception applies to drugs that have been dispensed in unit dose forms or in sealed ampoules that allow the pharmacist to determine if they have been tampered with and that they meet standards for storage conditions, including temperature, light sensitivity, and chemical and physical stability. In addition, pharmacies serving hospitals and long-term care facilities may accept drugs for return and reuse under similar circumstances. Controlled substances may not be returned to a pharmacy except to be destroyed.
There are liability protections for entities that donate, accept, or distribute prescription drugs that have been exchanged through a drug donation program. Under the program, practitioners, pharmacists, medical facilities, drug manufacturers, and drug wholesalers may donate prescription drugs for redistribution without compensation. The drugs must meet specific packaging standards and pharmacist review requirements. Approved drugs may be distributed to any patient, but priority is given to patients who are uninsured and have an income of 200 percent of the federal poverty level or less.
Individual persons and their representatives are added to the types of donors who may donate unused drugs to a pharmacy for redistribution under the prescription drug donation program. Individual persons who wish to donate to the program must complete and sign a donor form, developed by the Department of Health (Department) to authorize the release and certify that the donated prescription drugs have not been opened, used, adulterated, or misbranded. A pharmacist must, in his or her professional judgment, determine that the drugs were stored under required temperature conditions using the drugs' time temperature indicator information. "Time temperature indicator" means a device or smart label that shows the accumulated time-temperature history of a product through the entire supply chain.
The requirements that priority for the distribution of donated drugs be given to persons who are both uninsured and have an income that is at or below 200 percent of the federal poverty level are changed to remove the income standard. "Uninsured" is defined as a person who either: (1) does not have health insurance; or (2) has health insurance, but that insurance does not include coverage for a drug that has been prescribed to the person.
Prescription drugs that require registration with the drug's manufacturer may be accepted under the prescription drug donation program and may be dispensed if the patient is registered with the manufacturer at the time of dispensing and the amount does not exceed the duration of the registration period. The liability protections that apply to drug manufacturers expressly apply to prescriptions drugs that may only be dispensed to a patient who is registered with the drug's manufacturer.
The Department's rulemaking authority related to patient eligibility, patient priority, and notice to drug recipients is eliminated. The Department's general rulemaking authority for the prescription drug donation program is also eliminated.
The bill is named the "Cancer Can't Charitable Pharmacy Act."
Votes on Final Passage:
January 1, 2017