FDA Issues Draft Guidance on Injectable Medical Products Packaging

The Food and Drug Administration (FDA) issued draft guidance regarding the packaging of certain injectable medical products. The FDA is charged with approving packaging for medical products, including the package type terms and discard terms. This draft guidance specifically updates the packaging requirements and definitions for multiple-dose and single-dose medical products, while introducing a new term, single patient use container.

In issuing the draft guidance on October 22, 2015, the FDA noted the increased practice of unsafe injections. Specifically, the FDA has stated that problem is the improper use of needles, syringes, and medication vials, causing contamination of the medication vials. Moreover, when these single use containers are subsequently used on more than one patient, cross-contamination occurs. The failure to follow safe injection procedure for single patient and single dose containers, the FDA notes, has led to bacterial and viral infection outbreaks.

The FDA hopes that the clear product packaging will help alleviate some of the mistaken injection procedures and reduce the transmission of blood-borne pathogens. Although the guidance is not a legal requirement, it is the current FDA position based upon current trends. The draft guidance can be found at the following link:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM468228.pdf 

© 2015 Houghton Vandenack Williams
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