Pharmacies get a second postponement of DSCSA requirement, now due March 1, 2016
FDA fiddles with legislated deadline schedule
Pharmacies and some health systems are getting another breather from FDA: the requirement to have product tracing information (at the lot level) on hand was supposed to go into effect on July 1, which was pushed back to November 1, and now is being pushed to March 1, 2016.
Many of the details of the Drug Supply Chain Security Act (DSCSA) were written into the law itself, but FDA has some degree of “enforcement discretion” even with mandated deadlines. Manufacturers were to begin collecting and then passing tracing data on Jan 1 of this year, but FDA pushed that off to May 1. Getting two postponements certainly indicates a less-than-enthusiastic response to the law, but as there are subsequent deadlines for other traceability criteria hitting in 2017 and beyond, the pharmacy sector will be compelled to get up to speed, eventually. The postponement is also an acknowledgement that FDA simply can’t shut down dispensing activity because of noncompliance; the effects on public health would be severe.
An Exploration of Compounding Practices
May 22nd 2025In a Q&A with Pharma Commerce, Kurt Lunkwitz, ProRx Pharma’s COO, uncovers the stringent requirements that 503B outsourcing facilities must abide by under the Drug Quality and Security Act, while also shedding light on the FDA’s impact when it comes to improving the safety, quality, and trust in compounded drugs.
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May 21st 2025In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.
