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For Opioid Solutions, the Law Points to Packaging

FDA singles out a specific form of drug packaging in a proposed part of its efforts to stem the tide of opioid addiction.

Eric F. Greenberg
Eric F. Greenberg

In one of its latest actions against an intractable public health problem, the US Food and Drug Administration might soon require many abused opioids to be packaged in blister packs containing specified numbers of doses.

This is a big deal because packaging structures are usually just incidental to legal and regulatory developments. Sometimes innovative designs will result from changes in law or regulation, and sometimes, as is increasingly true these days, materials or structures like single-use plastics or straws are the subject of specific legal restrictions or requirements. But it’s rare that a particular packaging configuration is named specifically in a legal or regulatory action.

That’s why it’s notable that, in its latest action to implement a new law, the Food and Drug Administration in late May asked for public input on the idea of requiring specific packaging, specifically “fixed-quantity unit-of-use blister packaging,” for outpatient dispensing of some immediate-release opioid drugs.

FDA wants to reduce “opportunities formisuse, abuse, inappropriate access, and overdose, and possibly reducing the development of new opioid addiction.” The agency makes clear that the “blister packaging configurations contemplated… would not be required to be the only packaging option available for these products,” so prescribers would keep the flexibility to exercise their professional judgment.

The agency wants “right-sizing” of prescribed opioids, so those who need the drugs can get them but unnecessary exposure to opioids is reduced.

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