Blister Packaging for Certain Immediate Release Opioid Analgesics for Treatment of Acute Pain – Docket No. FDA-2019-N-1845 as it relates to opioid packaging, and recently passed Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients (SUPPORT) Act, passed in late 2018.

At this point in 2019 it is impossible not to give some well-deserved attention to the departure of Dr. Scott Gottlieb from the U.S. Food and Drug Administration (FDA). Anyone associated with pharmaceuticals or packaging was surprised at the announcement.

The Federal Drug Administration (FDA) is putting a full court press on the opioid crisis, and unit-dose packaging looks to be part of the team.

As 2017 heads toward the final quarter and the time intended for the Drug Supply Chain Security Act (DSCSA) to implement step 1, i.e., all pharma manufacturers distributing only serialized primary containers into the supply chain, we’ve learned a few things.

In 1970, Richard Nixon signed into law the Poison Prevention Packaging Act (PPPA). The act was written in response to a growing number of child poisonings from unintentional ingestion of drugs and other products. The Act was successful, but a lot has changed in the last 47 years.

The recently introduced Bill HR 1245 IH, the ‘‘Affordable and Safe Prescription Drug Importation Act’’ attempts to open the door to lower cost drugs via Canadian pharmacies.