FDA – Draft Guidance on Packaging of Injectables

FDA has released a draft guidance document providing the agency’s recommendations for the selection of appropriate package type terms and discard statements for injectable medical products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.”



 Posted by Tim Sandle