FDA ConneKTion

Timely updates and insights on the latest issues affecting FDA-regulated companies from Kilpatrick Townsend

Archive for August 2016

Posted on Tuesday, August 30 2016 at 5:57 pm by -

FDA Issues Final Rule Extending the Compliance Dates for Certain Specific FSMA Provisions In Four of the Implementing Rules: All Other Compliance Dates Remain Unchanged.

By: Carolina M. Wirth

As the compliance dates for the final rules issued by the Food and Drug Administration (FDA or Agency) implementing the requirements set forth by the Food Safety Modernization Act (FSMA) get closer, FDA is starting to address concerns about the “practicality of compliance” with certain specific regulatory provisions set forth by the final rules implementing the FSMA.[1]  On August 24, 2016, the FDA issued a final rule extending and clarifying the compliance dates for specific provisions in four of the final rules implementing FSMA:

  • Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (80 Fed. Reg. 55,908)
  • Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (80 Fed. Reg. 51,670)
  • Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals (80 Fed. Reg. 74,226)
  • Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (80 Fed. Reg. 74,354)

Below are some highlights from the final rule.


Read the rest of the entry…