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FDA Inspections Put Compounding Pharmacies In Regulatory Gray Zone

Michael Tomsic

Now, a follow-up on a series we aired earlier this year on drug shortages in hospitals. We called it Critical Supply, and we found that compounding pharmacies help hospitals fill the gap with some chemotherapy treatments, emergency crash-cart injections and even basic vitamins that go in IV fluids.

A compounding pharmacy that served many hospitals in the Carolinas remains shut down months after its state board of pharmacy said it could get back to work. That's because the Food and Drug Administration has effectively kept it shut down. But whether the FDA has the authority to do that is unclear. Today, WFAE’s Michael Tomsic reports on the challenges of meeting the FDA’s standards.

From the front, Medi-Fare Drug Center in Blacksburg, SC, looks like your traditional mom-and-pop, small-town pharmacy. Owner Pat Stephens even works the cash register on occasion.

Credit Michael Tomsic
The front of Medi-Fare.

"Six, seven, eight, nine, ten, and ten is $20," Stephens said as she gave change to a young man who bought an ointment to treat poison ivy about two months ago.

But in the back of Medi-Fare, it’s a different world.

Air roars through the clean room. This is where technicians are supposed to mix and customize prescription drug cocktails that aren’t commercially available.

It was a test day for a new air filtration system in mid August. The air has to flow to a certain way to meet FDA standards. Jesse Gillikin is a consultant working with Medi-Fare.

"We're preparing to do some smoke testing over the newly installed HEPA filters," Gillikin said.

Gillikin broke a glass vial, and white smoke began pouring out. He held it near the vents, which pushed the smoke straight down over the area where technicians will compound. The idea is to have clean air flowing over a drug mix.

"You can see that the smoke is getting below where the top of the tables would be," Gillikin said. "I think the tables are 40 inches. It's a big improvement from the last design."

It’s been a long 9 months for Medi-Fare's owner. FDA inspectors have come several times since December, telling Stephens her clean room isn't up to par. She's trying to comply. And in the meantime, the biggest part of her business is shut down.  

"We've laid off 23 people," Stephens said. And that's out of a staff of close to 30.

It's also meant that about two dozen hospitals in the Carolinas are forced to go elsewhere to get some drugs in short supply. That includes hospitals in Carolinas HealthCare System.

But whether the FDA has the authority to effectively shut down Medi-Fare, or other compounders, is unclear. Sheldon Bradshaw was the FDA's chief counsel from 2005 to 2007.

"The FDA has the authority to regulate drug manufacturing," Bradshaw said. "The FDA does not regulate the practice of pharmacy. That's regulated by the states."

Bradshaw said the line between manufacturers and compounding pharmacies used to be clear. Compounders mixed drugs for specific patients in their communities, while manufacturers created drugs in bulk and often shipped them across the country.

But that line blurred as some compounders grew into big businesses.

"They're going out and creating an entire line of drug products," he said. "They're hiring a sales force. They're going out and marketing these products to doctors like a drug manufacturer would."

An example is the compounder in New England linked to a deadly meningitis outbreak that started a year ago. There were hundreds of infections across the country, and more than 60 people died.

In response, the FDA has increased inspections of compounders, arguing they're more like manufacturers. But Bradshaw said that can be a tough argument.

"Where you have a gray area is in these cases where you have a smaller mom and pop pharmacy like the one in South Carolina that’s engaged in some compounding, perhaps even in bulk, in response to a request from a hospital for products that aren't commercially available," he said.

Hospitals have made more of those requests to Medi-Fare and other compounders as drug shortages have intensified in the past few years.

The FDA has inspected about 70 compounding firms in the past year, said Howard Sklamberg, the director of the FDA Office of Compliance. Sklamberg acknowledged the FDA's authority over compounders is unclear. But he said, "We don't send into a firm lawyers with law books."

"We send scientists and trained professionals who know how sterile drugs are supposed to be made," Sklamberg continued. He said inspectors have found startling conditions, like pharmacists using a coffee filter to filter drugs.

"We inspect and we look at the conditions in a firm, then we come back to FDA, and if there's an emergency, we take care of it," he said. "But when we think of using the law, we then consult our lawyers."

So it's inspect first, figure out the law later. Sklamberg said that's the way it has to be because compounders don't have to register with the FDA.

"Until we walk in the door, we may not know what products they're making," he said. "We may not know whether they're getting prescriptions. We may not know the size of their operation. We may not know a whole bunch of facts that would be relevant to what law applies.

At least 19 pharmacies have shut down their compounding operations in the past year, and at least 17 have recalled drugs, according to the FDA.

Very few of the compounders inspected have met the FDA's manufacturer standards. That's no surprise to David Miller, the CEO of the International Academy of Compounding Pharmacists.

"The federal government has changed the rules and inspected with a different rule book, and then told them that they can't do business unless they follow rules that were never designed for a pharmacy in the first place," Miller said.

The manufacturer standards are much stricter and more expensive to meet than state standards governing compounders under current law.

Here's one example: manufacturers have to wear biohazard suits that cover their entire bodies when they're making drugs. Compounders don't, and can leave parts of their face, forehead and neck exposed. 

Congress is working on a new law to govern big compounders.

"We want to clarify the FDA's authority in this realm, particularly in regard to compounders who try to pretend that they're not manufacturers," Rep. Morgan Griffith of Virginia said during a hearing this summer. "And that's sometimes difficult, and I understand that."

But until a new law makes the distinction clearer, the FDA has decided that doing nothing isn't an option.  

"We're looking to see whether the procedures a firm uses are safe for the products it's making," said Sklamberg, the FDA compliance director. "When products are sterile products that are going to be injected into the human body, they have to be made very carefully because when you inject a bacteria or a fungus into someone's blood stream, they could get sick, they could die."

Credit Michael Tomsic
Pat Stephens stands in front of workspaces in the clean room she had to redesign as she's trying to meet FDA standards.

Back at Medi-Fare, Pat Stephens is aiming to meet the manufacturer standards by mid October.

"This is the choice I've made," she said. "And I'm certainly not going to sit here and tell you that my fellow compounders should follow the same path."

That's because of cost and time. Medi-Fare's consultant says it costs an average facility about $35,000 dollars to comply. And even once Medi-Fare gets there, the FDA hasn't promised Stephens that she'll be able to compound again.