While we wait for the FDA to compile and review the responses to its request for comments on Fixed Quantity Unit of Use Blisters Packaging, Docket No. FDA-2019-N-1845 in response to the SUPPORT Act of 2018, we want to take the safer packaging of opioids conversation a bit further.
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.
Anyone associated with pharmaceuticals and packaging is likely aware President Trump signed the SUPPORT Act recently. The Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, also known as SUPPORT for Patients and Communities Act, includes a specific address to the type of packaging that should be utilized to stem the tide on opioid addiction.
From a packaging perspective, the legalization of marijuana — or more appropriately, taking it from prescription-only use to recreational — isn’t unusually complicated. Protect the product from moisture and oxygen. What about light? I’m not sure, but I guess there are those who will know.
The year was 1987. When then-President Ronald Reagan signed the Prescription Drug Marketing Act, the first passed legislation including the concept of pedigree for pharmaceuticals. It was also the precursor to the 2013 Drug Supply Chain Security Act signed by President Obama.
In its most recent article, the HCPC reviewed how the FDA was looking at a variety of alternatives to stem the opioid epidemic. The HCPC has been involved in this effort by promoting the wide-ranging benefits of unit-dose blister packaging.
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 January 2020 Packaging Strategies offers a culmination of tips and best practices in “Best Practices for Packaging Line Optimization,” and the 2020 Packaging Design Forecast, along with articles on fiber laser marking, HMIs with a more human touch, rigid plastic sustainability and more!