A tussle between a Texas compounder and the Food and Drug Administration underscores the ongoing difficulties that regulators can have overseeing this controversial portion of the medical supply chain.
The episode also illustrates how varying approaches taken by state and federal authorities to regulating compounding pharmacies can leave doctors and patients confused about the safety of medicines.
Here’s the back story: Last month, the FDA issued a health alert recommending that doctors and patients should toss sterile medicines made by IV Specialty. The agency found numerous safety issues during an inspection earlier this year, but the compounder refused an agency recommendation to halt production or issue a recall until the problems were fixed.
The FDA, which is not aware of any side effects attributed to the drugs, lacks authority to force the compounder to take these steps. Meanwhile, though, the medicines, which are injected or infused, remain available.
So earlier this week, Public Citizen, the consumer advocacy group, urged the Texas State Board of Pharmacy to suspend the compounder’s license. The FDA “uncovered multiple egregious, life-threatening problems in the company’s processes for making sterile drugs,” the advocacy group wrote to the state regulatory agency.
However, the Texas State Board of Pharmacy is declining to do so.
Why? In response to the FDA actions, the state agency sent its own inspector to review IV Specialty facilities. But “our inspector was comfortable that there wasn’t an immediate danger to the public,” Gay Dodson, the board’s executive director, told us. “According to our rules, they’re doing what they need to do. We didn’t see anything that we felt would prompt us to immediately close them down.”
She noted that state regulations are not as stringent as FDA regulations. This is not to say the state agency has given IV Specialty the proverbial clean bill of health. Her office issued five warning notices last month to the compounder for different violations, but is awaiting a response by April 24. Dodson added that her agency is also “working with the FDA.”
The incident underscores the unsettled approach to government oversight of compounders in the wake of a scandal in 2012. In that instance, injectable steroids made at the New England Compounding Center were linked to 64 deaths and more than 750 cases of fungal meningitis around the country. The episode cast a harsh spotlight on compounders and FDA oversight.
In response, the Drug Quality and Security Act was passed and beefed up FDA authority to inspect facilities and enforce regulations. In some ways, though, the effort remains a work in progress.
“We’re still in the early stages of figuring out how state and federal regulation schemes are going to work,” said Elizabeth Jungman, director of public health programs at Pew Charitable Trusts, which tracks compounding issues. “So it’s confusing for patients and physicians to see disagreement between regulators at state and federal levels.”
A Pew analysis issued two months ago found that state oversight of compounders is a spotty patchwork of regulations. Only about half of the states require compounding pharmacies that make sterile medicines to fully comply with recognized quality standards.
Meanwhile, Public Citizen points out that the Alabama Board of Pharmacy last month ordered a compounding pharmacy to halt production shortly after the FDA inspected its facilities and found safety problems.
As for IV Specialty, this was not the first time that the FDA cited it for quality control issues. The agency sent a warning letter last year after an earlier round of inspections.
Carlos Garcia, the pharmacist at the compounder, wrote us that IV Specialty is upgrading facilities, including its clean room and sterility testing procedures. “With these steps in place, we are confident we can provide a sterile product while our clean room is awaiting upgrades,” he wrote us. He added that none of its products ever failed a sterility test.
He also said that IV Specialty is a “small, local pharmacy” that only mixes medicines in response to a physician order and does not provide medicines at a later date or for use in a physician’s office. The compounder, he also noted, does not ship medicines to other states.
The FDA should probably inspect compounding facilities more often! Although there are some facilities that may not be up to standard, this doesn’t mean that all of them are! I wonder how this issue can be combated. Maybe more workshops and training should be done?
I would like to make a comment that I know what happened at this pharmacy personally. The FDA cited them for things that are required of manufacturers, such as the technician preparing an individual product had the skin on her forehead exposed. The FDA wanted them to recall all the products they had made, but the pharmacy doesn’t prepare any products with a beyond use date of more than 7 days. The pharmacy tested everything they prepared between the time the FDA visited them and the date they could get a reputable contractor to come in and change out the air handling system (the previous system didn’t have a high enough air flow rate for the positive pressure needed) and replace it. This visit by the FDA inspectors also made Mr Garcia pull all the original prescriptions for non compounded items I have filled for my cats such as mupirocin ointment, methimazole tablets, Lantus insulin and azithromycin oral suspension. They insisted that I provide them with a copy of the original written Lantus prescription that I had originally filled at a chain pharmacy and had transferred to IV Specialty to save money because IV Specialty allows me to purchase the medications at cost. I am a relief pharmacist for IV Specialty. I am IV certified and previously taught aseptic technique in the Sterile Products Course when I was on faculty. The technician preparing the IV medications has been an IV technician since I did my residency in the 1970’s. She is one of the most competent IV technicians I know. The state board of pharmacy gave them a citation because the technician left the clean room to get a vial from the ante room and didn’t change out her hair cover, mask and booties before going back into the clean room. There is plenty more I could say about the whole incident, but I will end with one comment. It appears that the FDA has swung too far to the other side since they got caught not doing their job at the New England Compounding Center. They are trying to make it look like there are all kinds of pharmacies and pharmacists who are doing a poor job even though we should not be held to the same standards as manufacturing facilities. I have been associated with IV Specialty for many years and I am proud to have my name associated with them. I would gladly have them prepare any IV medications for myself or my family. If anyone has further questions about this, you may contact me.
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