Title: Compounding and Reconstituting Drugs for Infusion in Establishments Other than Pharmacies
WHEREAS, recent tragic events involving contaminated, adulterated, or misbranded products that were compounded and reconstituted for infusion have demonstrated that significant risks exist when drugs are not properly compounded and reconstituted for infusion; and
WHEREAS, it has been brought to the attention of many boards of pharmacy that a variety of medical practices, including but not limited to, oncology, rheumatology, and gastroenterology practices, employ nurses and registered or unregistered pharmacy technicians to compound and reconstitute sterile products for infusion to patients in their clinics; and
WHEREAS, these compounded and reconstituted products often involve complicated calculations and the final product may not be checked by the prescriber prior to administering or dispensing to the patient; and
WHEREAS, it is uncertain as to whether these individuals and clinics fully comply with United States Pharmacopeia (USP) guidelines for the preparation of sterile products for infusion, potentially leading to unsafe conditions and unnecessary risk to patients; and
WHEREAS, it may be in the best interest of protecting the public to require that the compounding and reconstituting of sterile products for infusion be overseen by a pharmacist and in compliance with applicable standards, including but not limited to, Chapter <797> of the most current edition of the USP;
THEREFORE BE IT RESOLVED that the National Association of Boards of Pharmacy collaborate with the Federation of State Medical Boards and the National Council of State Boards of Nursing to assess the impact on patient safety of the compounding and reconstitution of sterile products for infusion in establishments other than pharmacies and without pharmacists’ oversight.
(Resolution passed at the NABP 109th Annual Meeting in St Louis, MO)