FDA publishes final guidance on packaging terms for injectable products in multiple-dose, single-dose, and single-patient use containers

Today, FDA published a final guidance document entitled “Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use.”  This guidance provides industry with the FDA’s recommendations on the selection of appropriate package type terms and selection of appropriate discard statements for injectable medical products for human use, packaged in multiple-dose, single-dose, and single-patient-use containers.  These containers may be part of a drug, a biological product, or a combination product assigned to CDER, CBER, or certain combination products assigned to CDRH.

Unsafe injection practices, including the use of needles or syringes for more than one patient or the improper use of medication vials for more than one patient, threaten patient safety and have resulted in multiple blood borne bacterial and viral infection outbreaks.  Bacterial and viral infections have been transmitted to patients when single-dose containers were used improperly, the contents became contaminated and these contents were then administered to multiple patients.  Failure to follow standard precautions and aseptic techniques has also been associated with several outbreaks of infections involving multiple-dose vials.  

FDA believes consistent use of correct package type terms and discard statements for injectable medical products for human use will promote their proper use and provide a foundation for educational efforts to reduce the transmission of blood borne pathogens