FDA May Get Authority Over Compounding Pharmacies

(Memphis) Officials with the Centers for Disease Control and Prevention now say there are 24 reported cases associated with suspect steroid injections made and shipped from Main Street Family Pharmacy in Dyer County.

That’s up from 20 last week. The agency updated a page on its website late Monday that keeps track of what’s now being called an outbreak.

More than a week ago, information surfaced that revealed Main Street had shipped possibly tainted steroid injections to medical facilities in several states.  The pharmacy has since voluntarily recalled more than 300 products.

History of Problems for Main Street

As federal and state health authorities search for the source of the problem, there’s a national push for more regulation over compounding pharmacies.

So what does that mean for the average consumer and their safety?

It may sound fancy, but compounding pharmacies have been around for hundreds of years.

“You’re taking multiple ingredients and combining that into a product for the patient,” explains Brett Wright, who runs Benevere Pharmacy in Collierville.

Think of the days when your grandma got sick. There weren’t always pain medicines on shelf, so the pharmacist created something. Fast forward to today, and places like that still exist.

“There’s not a one size fits all, so all medications don’t fit all the needs of patients,” adds Wright. Like other compounding pharmacies, pharmacists at Benevere can mix up drugs to create something patient specific.

Wright says, “We can convert a capsule over to a liquid, that’s a good example.  Also, we make transdermal cream so if people have some side effects, issues swallowing, they might take a medicine orally, we can combine that into a cream.”

Benevere doesn’t make injectables and they don’t ship across state lines. This is where the problem seems to lie. Compounding pharmacies that mass produce fall into a gray area.

Unlike big pharmaceutical companies that make new drugs, compounding pharmacies side step federal scrutiny, so oversight is up to each state.

The pharmacy at the center of the meningitis outbreak and the Dyer County pharmacy under investigation now shipped medication to dozens of states.

A proposed senate bill would give the FDA authority over such compounders.
So what can consumers do?  One solution is to maybe ask your doctor more questions about the pharmacies they do business with.  However, Wright says it shouldn’t come to that.

“That’s the intent of that law, so you don’t have to ask those questions, so you’ll be confident that what you’re getting is okay.”

Senator Lamar Alexander (R-TN) is a co-sponsor of the Pharmaceutical Compounding Quality and Accountability Act.  It’s supposed to head to the full Senate soon.

Those who oppose the measure say it could limit the availability of specialized drugs to patients who really need them.

In Tennessee, pharmacies must have a separate license for wholesale, manufacturing and distribution. The Board of Pharmacy is also responsible for inspections. They tell WREG there’s no set number required each year.

 


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