FDA Guidance Revises Packaging Terms for Injectable Products

The FDA issued final guidance on “single-dose” and “multiple-dose” containers for injectable medical products — introducing a new term “single-patient use.”

The containers may be part of a drug, a biological product, or a combination product assigned to CDER, CBER, or certain combination products assigned to CDRH.

The agency revised the terms after the improper use of single-dose containers led to the transmission of bacterial and viral infections in multiple patients.

The FDA defines a single-dose container — such as a vial, prefilled syringe or ampule — as “a container of a sterile medication for parenteral administration (injection or infusion) that is not required to meet the antimicrobial effectiveness testing requirements.” The container, which should be labeled as a single-dose container when there’s space and include appropriate discard statements, is intended for use with a single patient as a single injection or infusion, the agency said.

Multiple-dose containers, such as vials, hold sterile medication for parenteral administration that have met antimicrobial effectiveness testing requirements or are exempt from them, the agency said. They’re meant to contain more than one dose of the product and should be labeled as such when there’s room.

Generally, they contain 30 mL or less of medication, and their beyond-use dates when opened or entered — when punctured with a needle, for example — are 28 days unless otherwise noted by the manufacturer on the label.

The guidance introduces a new term — single-patient use container — and retires the term single-use due to past confusion, after it was wrongly interpreted as being interchangeable with single-dose.

The term single-use container was previously used by the FDA for package types that contained multiple doses but were intended to be used by a single patient. The new term is designed to make it even clearer that only one person should use it.

Sponsors should determine the proper package type term for the injectable medical product and use only that term in the labeling. The appropriate package type term should appear on all labeling components — including the container label and carton labeling, prescribing information, and labeling intended for the patient — to make it obvious to the user.

Multiple-dose containers typically don’t require a discard statement because of their assumed beyond-use dates; however, if their beyond-use date exceeds 28 days, an appropriate discard statement should be placed on the container label, carton labeling and prescribing information.

Applicants should make the necessary labeling changes and identify any changes made in annual reports and supplements within two years of the guidance’s publication, the agency said.

Read the guidance here: www.fdanews.com/10-02-18-Labeling.pdf. — James Miessler