June 1, 2019

FDA Proposes Fixed-Quantity Blister Packaging for Certain Opioids

In an effort to reduce excess drug supplies that can lead to opportunities for opioid misuse, abuse, addiction, and overdose, the FDA has proposed the requirement that certain immediate-release opioids be made available in fixed-quantity, unit-of-use blister packaging.

Citing new authorities granted to them by the passage of the SUPPORT for Patients and Communities Act, the FDA hopes to accomplish this goal by updating the REMS (risk evaluation and mitigation strategy) program for various opioids.

The FDA has reviewed published studies that compared the amount of opioid analgesics patients received to treat acute pain and compared it to the actual number of opioids used by such patients. Data suggests that using five, 10, or 15 count blister packaging reduces the number of unused opioids available for diversion, which could reduce the harm of the opioid epidemic.

Before making any policy decisions, the FDA is first soliciting public feedback on this proposal, asking for comments on:

  • Potential public health impact
  • Specific opioids that would be good candidates for blister packaging and what the number of pills to be included in the configurations should be
  • What specific information regarding the safe and effective use of opioids should be included in these blister package configurations
  • Potential challenges and negative impacts to this proposal
  • How to implement this proposal in a staggered fashion
  • And more

The FDA will be accepting public comment through July 30, 2019.

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