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Patrick Stone

FDA Compliance

It’s Time for the FDA and States to Step Forward for Public Health

It shouldn’t take nearly two years to conduct a compound pharmacy inspection

Published: Tuesday, December 11, 2012 - 10:52

It’s clear that the Food and Drug Administration (FDA) should have more compounding pharmacy oversight, but how long will it take them to make other important decisions on public health?

The recent news is troubling.

For example, a shipment of tainted steroid from a Massachusetts-based compounding pharmacy was linked to the recent U.S. meningitis outbreak. According to state and federal records, it took the FDA approximately 684 days to issue a warning letter that may have saved lives and time. Usually it should only take 90 days for the compliance branch, local district directors to decide on a firm’s regulatory outcome. The FDA mandates a strict response time—15 days—for an audited company to reply after a 483 is issued. The FDA should also be held to a 60- or 90-day turnaround.

As a former FDA inspector, I’ve been there. Some of the cases I was involved with took 24 months to get a final warning letter decision. This is unacceptable because there is a six-month follow-up that should be conducted.

But if regulators give the regulated industry time to make more lethal products, who is to blame? Usually the FDA gets local state authorities involved for immediate detention and embargo of harmful products. Each state has unique authority over products made within its borders if such products are held for interstate trade. The New England region was also involved with the FDA inspections of the Massachusetts-based compounding pharmacy. The state could have stopped many products from interstate trade before the situation escalated.

The warning letter sent to the Massachusetts-based compounding pharmacy was based on the FDA’s initial inspection that began in September 2004 and ended on Jan. 19, 2005. It does not take that long to conduct a compound pharmacy inspection or to collect product samples. It usually takes two or maybe three weeks for this type of inspection. Each district has time limits that can be spent on any one assignment. There seems to be a pattern of errors here that could have prevented lives from being lost with much time wasted.

Going forward the FDA must adhere to internal timelines for all inspections and final regulatory compliance determinations. State Pharmacy Boards should allow FDA inspections of firms that compound sterile drug products for conformance with U.S. Pharmacopeia (USP) chapter <797> “Pharmaceutical Compounding—Sterile Preparations,” or current good manufacturing practices (cGMP). Compound pharmacies should partner with the FDA to ensure safe market distribution of approved drugs.

This should not be a regulatory turf war; it’s a matter of public safety. The state should be brought in early, and if necessary take immediate detention and hold actions. This is a tragic learning experience that should be reviewed with rapid corrective action implementation.

This article first appeared in the Dec. 5, 2012, 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.