FDA Finds 'Unsanitary Conditions' at 30 Specialty Pharmacies

FDA compounding pharmacies consumer safety
Manuel Balce Ceneta/AP FDA Commissioner Margaret Hamburg, foreground, speaks at a news conference Wednesday in Washington. The agency says it has uncovered potential safety problems at 30 specialty pharmacies.
WASHINGTON -- The Food and Drug Administration says it has uncovered potential safety problems at 30 specialty pharmacies that were inspected in the wake of a recent outbreak of meningitis caused by contaminated drugs.

The agency said its inspectors targeted 31 compounding pharmacies that produce sterile drugs, which must be prepared under highly sanitary conditions. The FDA said Thursday it issued inspection reports to all but one of the pharmacies citing unsanitary conditions and quality control problems, including: rust and mold in supposedly sterile rooms, inadequate ventilation, and employees wearing non-sterile lab coats.

The agency generally issues such reports before taking formal action against companies. Inspectors visited pharmacies in 18 states, including Florida, Arizona, Colorado, Tennessee and New Jersey.

The wave of inspections comes in response to a deadly fungal meningitis outbreak linked to contaminated steroids from the New England Compounding Center, a Massachusetts pharmacy. The company's injections, mainly used to treat back pain, have been linked to 53 deaths and 733 illnesses since last summer.

Compounding pharmacies are supposed to mix customized prescriptions based on individual doctors' instructions. However, some pharmacies like the New England Compounding Center have grown into larger businesses, supplying bulk quantities of injectable drugs to hospitals across the country.


The FDA has stepped up its oversight of the pharmacies since the outbreak was identified in September, but agency officials say they have been slowed by the complex overlap of various state and federal laws that govern the industry. Pharmacies are licensed and overseen by state pharmacy boards, though the FDA sometimes intervenes when major safety issues arise.

In a blog post to the FDA's website Thursday, FDA Commissioner Margaret Hamburg noted that four pharmacies initially refused to admit the agency's inspectors. In two cases the agency had to return with search warrants and U.S. marshals to complete the inspections.

"These challenges and others highlight the need for clearer authorities for FDA to efficiently protect public health," Hamburg stated.

Hamburg has asked Congress to pass new laws giving the FDA explicit oversight over large compounding pharmacies. Under the proposal, large compounders would have to register with the FDA and undergo regular inspections, similar to pharmaceutical manufacturers.

But the FDA proposal has faced pushback from some members of Congress, particularly House Republicans, who have been investigating whether the FDA could have prevented the meningitis outbreak using its existing powers.

The House Energy and Commerce Subcommittee for Oversight and Investigations will hold its second hearing on the issue next Tuesday. Hamburg is scheduled to testify, according to committee staffers.

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43 Comments

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kindhearted28037

Dont want the FDA being in total control over compounding pharmacys,Alerternative medicines are gaining popularity because they work and most people trust them .Notice how many commericals on drugs with awful sideeffects approved by the FDA and the lawsuits that are pending. Majior drug companies and the FDA dont want an increase in alernative meds. its trotting on their terriory, money power ect. Im like most people , FDA approved ,, watch out !!!!!

April 15 2013 at 7:28 AM Report abuse rate up rate down Reply
Amber Womack-Kitavi

I dont trust the fda they are full of bs!!

April 14 2013 at 8:03 PM Report abuse +1 rate up rate down Reply
jekap55

What about the overseas factories where our generics and solutions are made. Look up the situation with Heparin from China which occurred several years ago. Over 100 people died. Ask yourself why you never heard about this.

April 14 2013 at 2:08 PM Report abuse +2 rate up rate down Reply
charpist5

Everybody should do what I do. Shun pills!

April 14 2013 at 12:12 PM Report abuse rate up rate down Reply
Elaine

Amazing how the government and business collaborate to keep the people uninformed. They feel they are more qualified to make decisions for you. therefore you don't get names, after all you could make the WRONG decision and not to use the company they are driving you to for there own profits. Too many business deals behind the backs of the people paying for it.

April 14 2013 at 12:12 PM Report abuse rate up rate down Reply
dencuddy

Thank God the government is looking out for our safety. Two refused inspectors? Shut them down!

April 14 2013 at 11:30 AM Report abuse +1 rate up rate down Reply
ccurt78

My wife who has had to use cancer drugs from a specialty pharmacy in the recent past, we were lucky and no problems so far. My question is what politicians pushed rules and regulations exempting them from oversite by the FDA, this did not happen by chance. Name the quilty parties and the packs,lobbiest and others who profit from the lack of oversight. We need to start putting people in jail, vote out of office and holp them finianicaly responsible for the damage they cause.

April 14 2013 at 6:30 AM Report abuse +3 rate up rate down Reply
polarbears217

Well, when everyone gets squeezed for a dollar, what does anyone expect?...Pharmacies are just like anything else....People expect to pay a nickel and get a drug....The state boards create hundreds of laws without equally restrictive laws to other professions....

April 14 2013 at 12:18 AM Report abuse -1 rate up rate down Reply
1 reply to polarbears217's comment
bjay0421

Are you saying they shouldn't inspect one place, just because they don't inspect some other one???
Two wrongs do not make a right!

April 14 2013 at 5:11 PM Report abuse rate up rate down Reply
victoria wheelr

Why do these pharmacies exist? The FDA has given a hard time to big pharma for decades. How did these micro-pharmacies come into being? I've used a drug created for a doctor i no longer see. it was an injectible vitamin. not any more, thanks. I used to work for Abbott Labs. They were constantly monitored by the FDA. how these little guys came into being is a major mystery. thank goodness the FDA is clamping down on them, before anyone else dies from their products.

April 14 2013 at 12:07 AM Report abuse +1 rate up rate down Reply
det0918

Liars! They are in bed with the drug companies and trying to shut these down and stop people from getting natural medications- they targeted ONLY COMPOUNDING PHARMACIES!!!

April 13 2013 at 8:50 PM Report abuse +1 rate up rate down Reply