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Regulatory Focus™ > News Articles > FDA Releases Draft Guidance on Injectable Drug Dose Labeling

FDA Releases Draft Guidance on Injectable Drug Dose Labeling

Posted 21 October 2015 | By Michael Mezher 

FDA Releases Draft Guidance on Injectable Drug Dose Labeling

Citing safety concerns, the US Food and Drug Administration (FDA) is updating its guidance to industry on how to properly label injectable drugs for their appropriate doses.

The guidance also updates the agency's definition of single- and multiple-dose containers and retires the term "single-use," in favor of the term "single-patient-use," which the agency says will reduce confusion for some products.


The introduction of this new term, "single-patient-use," is meant for products containing multiple doses that are intended to be taken by a single patient. The agency defines "single-patient-use" containers as follows:

"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."

For products that fit that description, including some injection pens, insulin products and drugs which rely on intrathecal administration, FDA says that labeling with either single- or multiple-dose is not accurate.

The agency also said that the previous term, "single-use," was sometimes "inappropriately used as if it were interchangeable with the term 'single-dose.'"

The agency says that proper use and labeling of injectable products is critical to ensuring patient safety, especially concerning the number of patients or doses a vial is intended to be used for. To illustrate its point, the agency points to dozens of viral hepatitis outbreaks in the past two decades all tied to improper injectable drug use in health care settings.

Because products using "single-patient-use" and "single-dose" containers do not have to demonstrate antimicrobial effectiveness, using these products improperly or sharing them between patients could lead to infection.

As drafted, the guidance recommends that sponsors update their labels as necessary within two years of being finalized. Specifically, products that were labeled "single-use" (intended for "a single patient as a single injection/infusion") should be updated to "single-dose," and included in an annual report.

For other term changes, such as from "single-use" or "multiple-dose" to "single-patient-use," the agency asks sponsors to submit the change as a prior approval supplement (PAS).


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