FDA Exercising its Authority to Inspect Compounding Pharmacies

March 08, 2022

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The fungal meningitis outbreak from the fall of 2012 that left over 700 people sick and 53 dead raised big questions about the compounding pharmacy industry, an industry not many people were aware of before the fatal outbreak that began at the New England Compounding Pharmacy. The incident brought to light the fact that compounding pharmacies are no longer the small-scale, mom-and-pop operations of 25 years ago. Instead, they have become massive manufacturing operations, falling through the cracks in terms of regulation.

Now, the FDA is stepping up an aggressive sweep of compounding pharmacies around the country. Compounding pharmacies fall in a middle ground in terms of regulation: they are not regulated by the FDA as normal drug manufacturers are, but a slew of them have become so big that for all practical purposes, they are drug manufacturers themselves. Instead of having to follow FDA regulations, they are regulated by the United States Pharmacopoeial Convention.

It is also unclear whether they are exempt from federal regulation and only subject to state law as a result of various judicial rulings. State pharmacy boards are thought to have the most authority to regulate this industry, but it is unclear when the FDA can step in.

What Did the FDA Find in its Inspections?

The FDA conducted inspections of 31 different compounding pharmacies from 18 states around the country, including Florida, Arizona, Colorado, Tennessee, and New Jersey. Thirty of these pharmacies had serious problems, including:

Rust or mold in ‘sterile’ rooms
Inadequate ventilation
Employees wearing non-sterile lab coats
Inadequate testing to determine expiration dates

Most of these compounding pharmacies create what should be sterile medications. For a medication to be sterile, conditions during manufacturing must be pristine. Inspections showed that this was far from the case.

It was exactly these sorts of violations that led to a batch of injections that were supposed to be sterile to cause fungal meningitis in the NECC incident last year.

It is also noteworthy that in several cases, the compounding pharmacies that the FDA sought to inspect would not allow the FDA entry without a warrant. These pharmacies think that the FDA does not have the proper authority, nor should be given authority. They believe that if the FDA begins to regulate the industry, it will lead to shortages with regard to critical drugs. But what of the safety of these drugs? Most people would probably rather find a shortage of drugs than risk death from contaminated products.

The FDA obviously disagrees with the compounding pharmacy industry’s view, and it hopes that Congress will grant them more aggressive authority to monitor this growing industry. The compounding pharmacy industry is thought to be worth between $3 and $9 billion. While this is a small fraction of the whole U.S. pharmaceutical market, which is worth $300 billion, it is still big enough to need strict regulation. The FDA points to the fact that these compounding pharmacies often mix allegedly sterile drugs in advance of receiving any prescriptions. This, they say, is proof that they are in the business of manufacturing. To make the problem worse, these pharmacies ship their products all around the country, leading to large-scale problems when problems do occur.

An Industry-Wide Problem

Almost all of us take prescription medications at some point in our lives. Most of us take something on a regular basis. When we get an injection at a doctor’s office or take a pill at home, we rarely worry about the sterility or safety of the drug we are taking. We trust that our system regulates such an important industry. Unfortunately, the compounding pharmacy debate is only the most recent proof that this is often not the case.

It is not only compounding pharmacies that often fail to keep patients safe. Regular drug manufacturers have failed just as often. Whether it is because they failed to provide adequate warnings, or because they marketed their drugs to an inappropriate group of people just to increase profits, the consequences are deadly and life-changing.

If you have been injured, an Attorney from Kirkendall Dwyer LLP can help.

The drug and device attorneys at Kirkendall Dwyer LLP have helped men and women from around the country who have been injured by a drug or device. These injuries are life-changing, and drug manufacturers should be held responsible. Whether you have been injured by a diabetes drug or a transvaginal mesh implant, or any other drug or device, contact our attorneys today to see how we can help you. Your case review is free, and we don’t get paid until you do. You have nothing to lose. Contact us today.

To read more about the Compounding Pharmacy Industry, read the following blogs:

The Quiet Rise of the Compounding Pharmacy

Dallas Compounding Pharmacy Causes Death