FDA Releases Draft Guidance on Packaging of Injectables

FDA has released a draft guidance document providing the agency’s recommendations for the selection of appropriate package type terms and discard statements for injectable medical products packaged in multiple-dose, single-dose, and single-patient-use containers. The guidance applies to new drug applications, abbreviated new drug applications, biologics license applications, premarket approval applications, and premarket notifications under section 510(k) of the Federal Food, Drug, and Cosmetic Act.

The guidance also provides revised definitions for single-dose and multiple-dose containers and a new definition for the term single-patient-use container. The revised definition for single-dose container states, “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.”

The guidance defines a multiple-dose container as “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.”

FDA defines a single-patient-use container as “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 guidance states that the proper package type should be determined and the correct term should be used throughout the labeling and on all components of the labeling, including the container label and carton and on prescribing information, where applicable. 

Source: FDA