The Pharmacy Quality Assurance Commission (commission) created a new rule, WAC 246-945-488, that went into effect on June 17, 2023 for the purpose of establishing an unexpired prescription drug donation program. The commission conducted rulemaking on this topic for the implementation of Substitute Senate Bill (SSB) 6526 (PDF) (Chapter 264, Laws of 2020).
The unexpired prescription drug donation program is optional. WAC 246-945-488 adopts the required conditions for donated prescription drugs outlined in chapter 69.70 RCW, but also adds a requirement that participating pharmacies must submit an additional form to the commission as notification of participation in the program. The commission will post a list of the facilities participating in the drug donation program under chapter 69.70 RCW.
When donating medications under the unexpired prescription drug donation program, the participating pharmacy must complete a drug donation form which must accompany the donated medications.
Participating pharmacies must develop policies and procedures that facilitate compliance with the statutory requirements. The policies and procedures must also include an additional requirement to notify the prescriber when donated medications are dispensed to a patient.
WAC 246-945-488 contains measures to ensure patient safety and product integrity such as separating the donated drugs from the rest of the pharmacy's drug stock and maintaining a separate inventory. The rule also adds the clarification that practitioners, pharmacists, medical facilities, manufacturers, wholesalers, or persons to whom a prescription drug was prescribed are not required to obtain a wholesaler license when donating drugs to a pharmacy.
Pharmacies must also notify the commission when terminating participation in the program. Notices of terminating participation in the unexpired prescription drug donation program must be emailed to the commission.