FDA Finalizes ASA-Supported Recommendations on Vial Sizes

In a positive step to mitigating drug shortages, the U.S. Food and Drug Administration (FDA) recently released a Guidance document for industry which recommends that “a drug product’s vial fill size should be appropriate for the labeled use and dosing of the product.”  The Guidance recommends that industry consider the following when determining what size vial is appropriate:

• “Single-dose vials should not contain a significant volume beyond what would be considered a usual or maximum dose for the expected use of the drug product.
• Consumers and/or health care providers should not be routinely required to use more than one vial to administer a typical single dose of the drug product.”

As part of its efforts to address drug shortages, ASA has long supported efforts to encourage industry to manufacture products in appropriately sized vials.

In June 2014, ASA submitted a letter to the FDA Commissioner strongly supporting these recommendations as initially proposed by the FDA in a draft Guidance to industry.  ASA is pleased the final recommendations are nearly identical to the draft recommendations.

In the letter to FDA, ASA explained that vial sizes appropriate for the labeled use and dosing of the product are imperative to reducing waste.  Some sterile injectables are produced in single dose vials larger than the dose required for a single patient, and physician anesthesiologists must discard the unused portion of the drug since most facilities do not have the equipment necessary to repackage the drug pursuant to the strict standards required by USP 797. 

ASA also explained that vial sizes appropriate for the labeled use and dosing of contrast, which is used in interventional pain procedures, are not always available and are often priced higher per milliliter than larger vials of contrast.  Due to these access and cost concerns, physicians are incentivized to purchase vials of contrast that contain a significant volume beyond a usual or maximum dose, which leads to waste of limited resources, increased costs to the health care system, and potentially microbial contamination if CDC infection control standards are not followed.

While the Guidance is not binding on industry, it represents the current thinking of the FDA on this topic and reflects the importance of appropriately sized vials to preventing waste.  ASA will continue to work closely with the FDA and stakeholders on these and other efforts to prevent and mitigate drug shortages.

Over the past several years, ASA has co-convened multiple Drug Shortage Summits during which key stakeholders work collaboratively to seek solutions to the issue.  As part of the Summit’s work, ASA has met with representatives of industry to request changes to vial sizes as a mechanism to reduce the waste of drugs in shortage.