FDA Finalizes Guidance on Package Type Terms and Discard Statements for Injectables
The US Food and Drug Administration (FDA) on Tuesday finalized guidance on the selection of appropriate package type terms and selection of appropriate discard statements for injectable medical products, packaged in multiple-dose, single-dose and single-patient-use containers.Specifically, this guidance provides FDA’s revised definitions for single-dose and multiple-dose containers as well as for the new package type term “single-patient-use container.”
The guidance is meant to help address 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, which have resulted in multiple blood-borne bacterial and viral infection outbreaks.
“FDA believes that 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,” the guidance says.
In the past, the term “single-use” container has been used by FDA to describe a package type that contained multiple doses but was intended to be used in a single patient, but FDA says the term “single-use” was also “inappropriately used as if it were interchangeable” with the term “single-dose,” which was not the agency’s intent.
“To address this confusion regarding the terminology, the Agency is retiring the term ‘single-use’ and a new package type term ‘single-patient-use’ container, has been created to address the need for describing a package that contains multiple doses of an injectable medical product that is intended to be used in a single patient,” the guidance says.
Examples of single-patient-use containers are patient-controlled analgesia cartridges and certain pens for injection.
For multiple-dose and single-patient-use containers, the antimicrobial effectiveness testing results, if performed, will be used to support the labeled beyond-use date or discard statements, FDA adds.
The guidance also features a section on labeling requirements and recommendations.
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: Guidance for Industry