However, the complexity of containers has the potential to raise challenges in operations.The Sysdig workshops are designed to help Dev Ops and developers build the robust skills needed to properly secure and troubleshoot their container and Kubernetes environments.
We can help ensure that your products are compliant with all labeling requirements.
Using our proprietary approach, we have a proven track record of helping our clients achieve successful interactions & compliance with FDA.
However, “if there is insufficient space to include this information on the container label, the package type term should appear on the carton labeling where it will be easily visible.” The discard statement should be included on the prescribing information for single-dose and single-patient-use injectable medical products, as well as on the carton (when there is space).
The guidance provides an example of discard statement for single-use products, which is: “Discard unused portion.” Because of the beyond-use-date, multiple-dose containers do not typically have a discard statement.
However, if the beyond-use-date is different than the assumed 28 days, a discard statement should be included on the container and carton labeling and in the prescribing information.
Examples of discard statements for multiple-dose containers include: According to the draft guidance, FDA is recommending that necessary labeling changes are made within two years of the publication of the final guidance.
The Agency also states that “all submissions (annual reports and supplements) should clearly identify the change(s) being made.
In addition, a supplement submission to follow the recommendations in the guidance should be identified as ‘Labeling Changes to Follow the Package Type Term Guidance.’” The guidance also provides recommendations for approved applicants submitting labelling changes (in accordance with the guidance), which can be found in the draft guidance here.
When space permits, a single-patient-use container is labeled as such and should include on the label appropriate discard statements.
Examples of single-patient-use containers are patient controlled analgesia cartridges and certain pens for injection.” In addition to providing the definitions listed above, FDA also listed various recommendations and requirements for the labeling of injectable medical products.
FDA has found that there is sufficient space to include the information on the carton labeling.