As of July 25, 2021, a new definition of “compounding” is in effect for the practice of pharmacy due to the passage of SHB 1445 (2021). SHB 1445 clarified the definition of “compounding” in RCW 18.64.011 to align with the federal definition of “compounding” by adopting the federal language regarding the mixing and reconstitution of sterile and nonsterile substances.
The new definition states: “‘Compounding’ means the act of combining two or more ingredients in the preparation of a prescription. Reconstitution and mixing of (a) sterile products according to federal food and drug administration-approved labeling does not constitute compounding if prepared pursuant to a prescription and administered immediately or in accordance with package labeling, and (b) nonsterile products according to federal food and drug administration-approved labeling does not constitute compounding if prepared pursuant to a prescription.”
According to the Washington State Pharmacy Association, the new definition means pharmacies will not be required to retain compounding records of reconstituted products as described in the new statute, nor will pharmacies be required to complete the compounding self-assessment on self-inspection worksheets. All other activities where two or more ingredients are combined in preparation of a prescription continue to be defined as compounding, which means pharmacies must continue to follow existing Pharmacy Quality Assurance Commission and USP guidelines.
This change also allows non-pharmacy staff to engage in reconstitution and mixing pursuant to the definition. Because of this, the Nursing Quality Assurance Commission will be releasing an update to its Compounding Advisory Opinion for nurses this fall that reflects the updated definition. (David Streeter)
