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Oklahoma has strict regulations for its compounding pharmacies

by Jaclyn Cosgrove Modified: November 19, 2012 at 12:18 am •  Published: November 19, 2012

The New England Compounding Pharmacy was shipping thousands of medicines across the nation. The difference in what Brooks is doing is that she knows who the medicine is for and is filling a prescription specific to one person.

“We individualized each person's medication, we compound it from scratch, package it, dispense it, and it goes out,” Brooks said.

Compounding pharmacies provide a wide range of drugs to their clients. These pharmacies fill prescriptions for hormone replacement therapy, pain relief, skin conditions and veterinary clinics, just to name a few.

There's a door inside the aseptic room that leads to the pharmacy's sterile room. To maintain good air quality in the room, no one is allowed in other than trained staff. Brooks will enter this room three or four times a day. Each time before she enters, she must use an iodine scrub and put covers on her shoes and wear a mask, apron, arm sleeves and gloves, among other things.

“Nothing on me is going to get in their product,” Brooks said.

It's no coincidence that Oklahoma has both tough compounding restrictions and is home to the International Journal of Pharmaceutical Compounding headquarters in Edmond.

Loyd Allen, the journal's editor-in-chief, has been a pharmacist for about 50 years and has played an integral role in shaping Oklahoma's compounding pharmacy laws.

Oklahoma was one of the first states to require pharmacists to take continuing education courses before they renew their license each year. That requirement was put in place 40 years ago.

At compounding pharmacies, pharmacists must monitor air quality. An Oklahoma compounding pharmacy's clean room must meet higher standards than a hospital operating room, Allen said. Compounding pharmacies in Oklahoma also must monitor the number of microorganisms found in certain parts of the facility. These are just a few of the requirements a compounding pharmacy in Oklahoma must meet, and for good reason, Allen said.

But it's not just regulations that must be in place. The state's pharmacy board has inspectors who visit most, if not all, Oklahoma pharmacies every year. Regulations have to be enforced to be worth anything.

“There's no reason why the FDA should not have closed the New England Compounding Center back in 2006,” Allen said. “They should have closed them down, no question about that, and they had the authority to.”

Why compounding?

Before there was Pfizer or GlaxoSmithKline or Merck or Bayer, there was a local pharmacist compounding. In the 1700s and 1800s, everything was made through compounding.

In the early 2000s, as pharmaceutical companies were merging, they were dropping the number of medicines they made, Allen said.

There are more than 8,000 prescription and nonprescription drugs that pharmaceutical companies have discontinued — not because they were not safe, but because they weren't profitable, Allen said.

“Compounding has continued to grow to meet individual patient needs that the pharmaceutical industry is not meeting right now,” Allen said.

Last year, there were about 270 drugs facing shortages. Whenever there's a drug shortage, a compounding pharmacy is allowed to make that drug to help increase access.

Allen said this is an example of the role compounding pharmacies play in the nation's health care.

“Bottom line is if you couldn't compound, doctors could not practice health care today because they're so dependent on it,” Allen said. “You cannot do surgery without compounded medications. You can't feed kids tablets and capsules — so where are they going to get their medications?”

by Jaclyn Cosgrove
Medical and Health Reporter
Jaclyn Cosgrove writes about health, public policy and medicine in Oklahoma, among other topics. She is an Oklahoma State University graduate. Jaclyn grew up in the southeast region of the state and enjoys writing about rural Oklahoma. She is...
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