Wednesday, August 28, 2013

We’re All at Risk While Drug Compounders Fight Regulation; One Person Doesn't Like the Odds

on August 27, 2013
The expected backlash to attempts by the FDA to crackdown on compounding pharmacies has begun, threatening public safety.
Dallas, TX compounder NuVision is refusing to voluntarily recall its sterile products, thumbing its nose at FDA requests following safety concerns stemming from a federal inspection of its production facilities this spring. In response, the FDA has issued two public alerts to health care providers not to use any sterile NuVision products and to “quarantine” any supplies in stock.
Shockingly, the FDA has no authority to require a compounding pharmacy to recall any products, even if inspectors have observed lax procedures that could endanger patients. Currently, compounding pharmacies, many of which began as small family-owned operations, are not considered “manufacturers.” But as compounders have flourished, many have become national, high-volume producers. A lapse in sterile procedures at one of these companies has the potential to endanger hundreds, if not thousands, of patients.

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1 comment:

Kenneth Woliner. MD said...

Sue, I ran out of characters, so I truncated my comment. Perhaps this comment deserves a post of its own. Perhaps you'll entitled it "The art of compromise 101".

This week I spoke with a few of the compounding pharmacists I called in prescriptions to. In addition to taking care of our mutual patients, I asked, "What do you think of s. 959 going through Congress now?" As expected, they all opposed it. "Why?" I asked. The first answer was always (3 pharmacists said the same thing, "The IACP (their trade organization) opposes it."

I pressed further by saying, "Okay, I can understand 'Mom & Pop Compounding' might not like the extra regulation, but if they aren't shipping drugs across state lines (it is only over the last 10-20 years that compounders have marketed themselves to distant areas, even outside their home state), they aren't subjected to increased Federal oversight. And I can understand you, as a 'good' compounding pharmacy (nice pharmacists with experience, training, good hearts, and no violations from the state boards, 483 letters from the FDA, or tragic examples of patient infections, blindness, or deaths) don't like extra regulation, but doesn't it 'GET YOUR GOAT' to see 'bad compounding pharmacies' such as Paul W. Franck (Franck's Compounding Lab, but now Trinity Compounding Pharmacy) blind humans and kill polo ponies with their shoddy practices?" As I thought, they don't like the 'bad pharmacies' either, as it gives them all a bad name.

I then said, what if the IACP is successful in preventing a Federal law from being enacted (just as


I offered up this compromise, "Perhaps you, the supervising pharmacist, and owners of your pharmacy, should speak with David Miller and the iACP, asking the IACP to work out a compromise, to protect the things you cherish most, but to allow the Federal Govenment (through the FDA) the ability to regulate the rogue compounding pharmacies (that are truly manufacturers in disguise, with sales reps all over the country, etc), to prevent further tragedies that harm not just patients, but also the reputation of your profession."

Their answer (for all 3 pharmacists I spoke to this week):

"That's something to think about."

Kenneth Woliner, MD