FDA published a new draft Guidance (with a name that might take up half of this blog post) entitled, “Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable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”. Go ahead- say THAT in one breath!
Anyway, this draft Guidance adds to the two specific terms that FDA has long use for parenteral products – single-dose container and multiple-dose container- but they have even tweaked those terms and now define them as follows:
Single-Dose Container: A single-dose container is a container of a sterile medication for parenteral administration (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/infusion. 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.
Multiple-Dose Container: A multiple-dose container is a container of a sterile medication for parenteral administration (injection or infusion) that has met antimicrobial effectiveness testing requirements, or is excluded from such testing requirements by FDA regulation. A multiple-dose container is intended to contain more than one dose of the drug product. When space permits, a multiple-dose container is labeled as such. Multiple-dose containers are generally expected to contain 30 mL or less of medication. The beyond-use date for an opened or entered (e.g., needle-punctured) multiple-dose container is 28 days, unless otherwise specified by the manufacturer in the label. An example of a multiple-dose container is a vial.
Due to the long history of inappropriate use of some parenteral products that have resulted in significant adverse health events (as described in the Guidance document), the Agency is introducing a new term – Single Patient Use Container – that more accurately describes the use of a product that has multiple doses, but should be used only for a single patient.
Single-Patient-Use Container: A single-patient-use container is a container of a sterile medication for parenteral administration (injection or infusion) that is intended to be used multiple times for a single patient. 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.
The types of submissions differ for NDAs and BLAs than for ANDAs for changes to package type designation. With the exception of the change from “single use” to “single dose,” which may be submitted in an Annual Report, other changes under this Guidance for NDAs and BLAs must be submitted as Prior Approval Supplements. Following approval, ANDA applicants may submit the change in a CBE-0. To view the draft Guidance in its entirety, please click here.