FDA Adds ‘Single-Patient-Use’ Label for Injectables

The FDA hopes to cut down on patient-to-patient transmission of blood-borne infections by clearly labeling injectable therapies that are meant to be used multiple times by a single patient as products for “single-patient-use.”

The new term would join the current “single-dose” and “multiple-dose” terms used to label containers of injectable and infusion therapies, the agency says in draft guidance released last week.

Under the guidance, a single-dose container is defined as being for use with a single patient as a single injection/infusion, such as vials, ampules and prefilled syringes. These are not required to meet the FDA’s antimicrobial effectiveness testing requirements.

Multiple-dose containers, such as vials, comprise more than one dose of drug product and are generally expected to contain 30 ml or less of medication. They must meet antimicrobial effective testing requirements, if not specifically exempted from FDA regulation, the guidance says.    

For both of these types, the antimicrobial effectiveness testing results, if performed, will support the labeled beyond-use date of discard instructions.

The FDA revised its definitions for single-dose and multiple-dose and added the new single-patient use term to eliminate confusion about each type of container’s intended use. The agency notes, for instance, that existing package type terms don’t convey that multiple dose containers, such as insulin pens, should only be used on one patient.

The agency wants the appropriate packaging term to appear on all components of the labeling, including the container label and carton and where applicable, the prescribing information. If there isn’t sufficient space to include this on the container label, it should appear on the carton labeling where it will be easily seen, the guidance says.

Drugmakers must comply with the new package terms within two years of publication of the final guidance. All submissions — annual reports and supplements — should identify that the changes being made.

Comments on Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products in Multiple-Dose, Single-Dose and Single-Patient-Use Containers for Human Use are due Dec. 21. View the draft guidance at www.fdanews.com/10-22-15-ContainerGuidance.pdf. — Kellen Owings