News: FDA Regulations, What is Next?

A lot of people have reached out to me and asked now that the commenting period is over, what comes next in regards to FDA regulations? Well according to an article posted by the Executive Director of CSPnet.com a website for connivence stores, the following happens.

After the dust settled from the public commenting period, a total of  82,000 comments were received. The comment period was Step 6 in a nine-step process.

The law requires the FDA to review each of the submitted comments and that could take up to a year. During this 7th step the FDA can draft additional regulations or change any of the proposed regulations after it completes the review process. If there are any changes to the original proposal the FDA needs to begin a new rule making process for any potential changes. The process would once again allow time for the public to comment.

In Step 8, the FDA submits the revised regulations to the White House Office of Management and Budget (OMB) which would then conduct a final review of the regulations from an economic impact perspective. There is no set timetable or deadline that the OMB must abide by in conducting the final review.

If the OMB approves the regulations then Step 9 would be the FDA issuing final regulations, setting a date that the regulations would actually take effect.

What this results in is an estimated 12-18 months before any deeming regulations are put in place. In the meantime, we must remain vigilant and continue to get our message out in a constructive method. Continue to support groups like CRA, IPCPR and vote for politicians that best reflect what is important to you.