TITLE: Development and Administration of Patient-Specific Biologics

WHEREAS, drug manufacturers often receive blood components from a patient for the development of a patient-specific biologic and the final formulation is shipped directly to a practitioner for administration to the patient; and

WHEREAS, it is unclear whether shipping of this patient-specific biologic by a manufacturer for patient administration comports with either the definition of wholesale distribution or dispensing as defined in state laws and the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy; and

WHEREAS, it is, therefore, unclear which type of license should be issued by the state to these manufacturers; and

WHEREAS, United States Food and Drug Administration (FDA) is approving an increasing number of biologics, which could result in manufacturers shipping an increased number of patient-specific biologics; and

WHEREAS, it is imperative that the state agency responsible for overseeing the drug supply chain protect patient safety by ensuring that biologics are shipped to practitioners in a safe and legally compliant manner;

THEREFORE BE IT RESOLVED that NABP consult with FDA about the legal framework authorizing manufacturers to ship a biologic containing a patient-specific blood component to a practitioner for administration to the patient, and recommend to its member boards the appropriate level and type of regulatory oversight.

(Resolution passed at the 116th Annual Meeting.)