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Patrick Stone

FDA Compliance

Former FDA Inspector’s Crystal Ball

Outlook is cloudy with a chance of inspected meatballs

Published: Wednesday, October 2, 2013 - 12:24

The Food and Drug Administration’s (FDA) “Food Police” will be in full force to secure budget funds for food safety initiatives for FY 2014 as mandated by Congress. More than half of the operating funds will be earmarked for food work.

International food inspections will surely be a focus area for the coming year. The inspection goals and quota of full-time equivalent employees will be set low enough for the field staff to meet or exceed expectations. This again will ensure a steady flow of billions for operating costs. In recent years large chunks of the FDA budget were set for the completion of new facilities and the dreaded infrastructure technology upgrades that barely seem to keep up with private industry.

Opioid labeling rules newly penned will assist in identifying and tracking legal drugs; however, Internet and backstreet sales will continue to plague the market. Insurance fraud is making it easier for mail-order diversion and outright secondhand sales of the legally obtained opioids. So until the insurance scams are tapered, this effort will only increase operating cost for the opioid manufacturers.

A medical device tax and new user fees will be required for doing business in our domestic market. It seems that every few years the fee structure increases and becomes more complex. Maybe this is part of the reason our health care costs are always going up exponentially. What will they think of next to add to the user fee list?

The agency has issued product-specific, sterile-drug consent decrees and lengthy 483 forms for current good manufacturing practices (cGMP) violations across the nation. Judging by the wording of some 483 reports, a few sterile-drug manufacturers will be handed consent decrees very soon. These firms are major market shareholders that have had ample time for remediation without compliance. The recalls from these same firms have been persistent all year.

The great 2013 compounding pharmacy blitz and new regulations request for these manufacturers was not much of a shock and even less awe. The faster the FDA defines what compounding drug manufacturing is and provides lengthy guidance on how it should not be done in a compounding pharmacy setting, the faster we will see market self-compliance. Compounding pharmacies must recognize themselves as manufacturing entities and adhere to strict USP 797 and 21 CFR 200 standards, which are costly.

Compounding pharmacies are the first line of defense when it comes to a drug shortage, so they must operate in strict compliance with the sterile-drug cGMP systems approach. More patients will have adverse events and possibly die from noncompliant or contaminated compounded sterile-drug preparations if the mindset of the manufacturers does not change. A state’s Board of Pharmacy cannot shield compounders from civil or criminal liability, and the FDA may soon have what it needs for implementing jurisdictional authority.

Here’s to an exciting 2014!

This article first appeared in the Oct. 1, 2013, edition of the AssurX blog.


About The Author

Patrick Stone’s picture

Patrick Stone

Patrick Stone works toward a future where disease cures and prevention are the main goal of all new test articles. Stone is president and lead consultant at TradeStone QA LLC, which serves the global public by protecting the supply and quality of healthcare products before entering the market place. Stone specializes in Institutional Review Board (IRB) compliance and quality assurance audits; computer system validation and 21 CFR Part 11 compliance; LIMS/data management system compliance; and 21 CFR, GCP, cGMP, and ICH compliance. Stone is the author of Bubble Gum Badge—An FDA His-Story (Xlibris Corp., 2011). You can follow Stone on Twitter.