- FDA Draft Guidance Outlines Appropriate Labeling for Injectable Drug Doses
- November 10, 2015 | Author: Scott S. Liebman
- Law Firm: Loeb & Loeb LLP - Washington Office
- The FDA released draft guidance on how to label injectable drugs for their appropriate doses, offering a new definition of single- and multiple-dose containers and replacing the term “single-use” with “single-patient-use.” Sponsors are being tasked with updating their labels as needed within two years of the guidance finalization.
The FDA published draft guidance offering recommendations on appropriate package type terms and discard statements for injectable medical products for human use delivered in multiple-dose, single-dose and single-patient-use containers, in an effort to overcome unsafe injection practices. The agency cited the transmission of bacterial infections to patients due to the improper use of single-dose containers, and the outbreak of infections due to a failure to follow standard procedures for multiple-dose containers, including 33 outbreaks of viral hepatitis in the U.S. between 1998 and 2008. The goal of the guidance is to allow for consistent use of correct package type terms and discard statements to promote the proper use of the products, while providing a foundation for educational efforts to minimize the risk of disease transmission.
The guidance revises the definition of both single-dose and multiple-dose containers. Single-dose containers do not need to meet antimicrobial effectiveness testing requirements and are designed for use in a single patient as a single injection or infusion; multiple-dose containers must meet antimicrobial effectiveness testing requirements or be excluded from such testing requirements by FDA regulation, and are intended to contain more than one dose of the drug product.
According to the FDA, the single-dose and multiple-dose terms are properly used, but in some cases a package contains multiple doses of a product that is intended for use in a single patient. Since the drug is designed for multiple doses, the term “single-dose” is not appropriate. Yet the multiple-dose term is inaccurate as well, since the contents may not contain a preservative or be able to pass antimicrobial effectiveness if tested. The agency previously classified products with multiple doses intended for a single patient as single-use, which led to inappropriate use due to the belief the term was interchangeable with single-dose. To address this, the draft guidance introduces the term single-patient-use container — defined as a container of sterile medication for injection or infusion intended to be used multiple times for a single patient.
The guidance calls on applicants to determine the proper package type term for injectable products and use the correct term throughout labeling, including the container label, the carton and, where applicable, the prescribing information. Applicants are asked to change labeling as needed to adhere to the guidance within two years of the publication of the final version.