FDA puts heat on compounding pharmacies

Agency mulling rules on ingredients businesses can use

By Tara Bannow, The Bulletin, @tarabannow

One hundred years ago, a pharmacist’s job was much different than it is today. Back then, they were the ones measuring and mixing ingredients for the medications they gave to patients.

But the rise of mass drug manufacturing in the 1950s all but removed pharmacists from that role.

The exceptions are compounding pharmacists, who prepare personalized medications for patients in their pharmacies. Often this is necessary because the doctor ordered a dose a manufacturer doesn’t make, the patient needs the drug in a different form or the patient is allergic to an ingredient in the drug.

“We’re just trying to keep our feet in the actual process,” said Angela Valerga, a registered pharmacist and pharmacy manager for Cascade Custom Pharmacy, which operates as both a compounding center and a traditional pharmacy. “We don’t just want to be bean counters.”

Compounding pharmacies are much more difficult to come by than chain pharmacies such as Walgreens or Rite Aid, but there are a handful of such pharmacies in Central Oregon.

In the future, it could become more difficult to perform drug compounding, as the U.S. Food and Drug Administration is developing stricter regulations around the practice, including a longer list of ingredients that can’t be used, even dietary supplements.

The scrutiny comes in the wake of a massive fungal meningitis outbreak in 2012 that killed 64 people and sickened 750. The outbreak stemmed from a steroid produced at the New England Compounding Center, which was mass producing products in unsanitary conditions. Congress passed legislation the following year designed to improve oversight of compounding facilities.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, which oversees compounding, explained in a news release that pharmaceutical companies operate under very strict rules to ensure their products are made in sterile environments that don’t expose patients to bacteria or other contaminants.

“So that drug supply is quite safe,” she said. But in situations where compounding pharmacies are making large amounts of products, “you have to be very careful that, number one, it’s made correctly, and then it doesn’t get contaminated.”

Violations in Redmond

The regulations, however, pertain to pharmacies of all sizes. Even Cascade Custom Pharmacy, a small store tucked in the Brooks­wood Meadow Plaza on Bend’s south side.

The 2012 outbreak had implications for state regulators, too. It prompted the Oregon Board of Pharmacy to step up its inspections of compounding pharmacies’ processes and procedures, said Marcus Watt, the board’s executive director. The board performs unannounced inspections of all pharmacies in Oregon at least once a year.

“What the Massachusetts issue has done has brought a higher level of understanding to us,” he said. “In the past, our inspectors weren’t as well versed as they are now in the proper techniques, proper processes, so we would probably have missed things.”

That extra scrutiny may have contributed to the board’s investigation of the Redmond Pharmacy and Compounding Center, which the board is seeking to shut down and fine $10,000 for each of more than a couple dozen violations.

The board says the Redmond pharmacy on numerous occasions billed insurance companies for more drugs than it dispensed, for more expensive drugs than it dispensed and for prescriptions patients had not received. The board also says the pharmacy used expired ingredients to compound medications and labeled the compounded drugs with later expiration dates than they should have had.

Watt said the pharmacy’s owner contested the allegations and the board will likely come to a resolution at its Dec. 17 meeting.

Rules around supplements

The compounding industry’s biggest issue with the FDA’s proposed rules is the plan to remove dietary supplements from the ingredients that can be used in drug compounding.

John Voliva, director of legislative relations for the Professional Compounding Centers of America, a trade group that represents compounding pharmacies, said it doesn’t make sense to allow large manufacturers to sell supplements but not let small compounding pharmacies do so. Voliva’s group represents only independent compounding pharmacies, although hospitals and some other types of medical facilities perform compounding, too.

“The FDA has a stance that it’s perfectly all right for a dietary supplement to be mass-produced, sold without a prescription at GNCs, at Wal-Marts, at convenience stores … but if a pharmacist would get the raw material for that same dietary supplement and compound it into a capsule or oral solution or something that can be applied to the skin, that’s not legal in their eyes,” he said. “We have a big, big issue with that.”

Removing supplements would make compounding much more difficult for Valerga’s business. For example, her staff adds vitamin B6 to some of the hormone replacement capsules they produce for patients because Valerga said those medications can deplete patients of that nutrient.

“There is no rhyme or reason with these natural products,” she said.

The ban would pertain to other popular supplements, such as 5-Hydroxytryptophan, an amino acid some take for depression; DHEA, a hormone often used to correct adrenal imbalance and other conditions; and licorice root extract, which is often used for digestive issues, Voliva said.

None of the FDA’s changes are final, and the agency is still accepting public comment. Lyndsay Meyer, an FDA spokeswoman, wrote in an email that there is no timeline for finalizing the new rules.

New rules on veterinary drugs

The FDA’s proposed rules around compounded drugs for animals will pertain only to nonfood animals like dogs and cats. The guidelines include requiring the drugs be compounded in a state-licensed pharmacy by or under the supervision of a licensed pharmacist or at a veterinarian’s office by a licensed veterinarian, as well as new labeling requirements. The FDA is also in the process of compiling lists of ingredients that can and cannot be used in compounding for animal products.

That makes Valerga nervous, as drugs for animals comprise about 40 percent of her compounding business.

“The FDA is really kind of overstepping their boundaries, and it’s really affecting the veterinary world,” she said.

Voliva said he can’t think of any other sector of medicine that’s more heavily scrutinized than drug compounding. That’s frustrating for advocates like him, as he said compounding allows patients to have a more personalized experience.

“It’s really kind of that stepping back in time and the pharmacist knows who you are and about the problems you’re having with your health and is really there to work with you one on one to try to solve your health problems,” he said, “versus it being not a very personal relationship you would get in the retail settings.”

— Reporter: 541-383-0304,

tbannow@bendbulletin.com

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