US FDA has issued the final guidance for Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers1 for Human Use.
This guidance provides industry with the regulatory authority recommendations on the selection of appropriate package type terms and selection of appropriate discard statements for injectable medical products for human use. Specifically, this guidance provides revised definitions for single-dose and multiple-dose containers as well as for the new package type term single-patient-use container.
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. These 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.
As part of its review of medical products, FDA clears or approves package type terms and discard statements as part of the labeling of injectable medical products. 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 package type terms single-dose container and multiple-dose container have been in use for a long time.
A single-dose container is a container of a sterile medication for parenteral administration which could be injection or infusion that is not required to meet the antimicrobial effectiveness testing requirements. A single-dose container is designed for use with a single patient as a single injection. When space permits, a single-dose container is labeled as such and should include on the label appropriate discard statements. Examples of single-dose containers are vials, ampules, and prefilled syringes.
A multiple-dose container is a sterile medication for parenteral administration that has met antimicrobial effectiveness testing requirements, or is excluded from such testing requirements by FDA regulation.
In the vast majority of cases, the package type terms ‘single-dose’ and ‘multiple-dose’ are properly used. However, in some unique situations, a package contains multiple doses of a medical product that is intended to be for use in a single patient. The medical product in this package type may not contain a preservative or be able to pass antimicrobial effectiveness if tested, yet this package type contains multiple doses for use in a single patient.
The regulatory authority recommends that applicants make the necessary labeling changes to follow these recommendations within two years of the publication of this guidance. All submissions should clearly identify the changes being made.
