http://www.bostonherald.com/news/regional/view.bg?articleid=1061167341&srvc=rss

Ted Kennedy targeted pharmacy

But lobbyists killed ’07 bill

By Erin Smith
Saturday, October 13, 2012

U.S. Sen. Edward M. Kennedy pushed for tighter regulations that may have prevented the nationwide deadly meningitis outbreak tied to a Framingham compounding pharmacy but was stopped cold by a well-financed industry group.

“The reaction of the compounding pharmacy group was to mount a very aggressive lobbying campaign,” said a former Kennedy staffer. “They identified pharmacists in key districts and sent them to lobby members.”

The industry group shunned requests to shape legislation and waged an “unprecedented” campaign to kill the draft bill, the former staffer said.
<more>

.......they are SUPPOSED to be compounding meds for specific persons, prescriptions. Like any pharmacy. They were never licensed to manufacture a widespread, widely distributed product.

Look, the Feds created laws that would prohibit such activity, just like there are laws against speeding, practicing law without a license, and felons owning firearms. The law is there and persons break the law. The law cannot predict who is going to comply with the law or not.

What I read is they were permitted to fill specific prescriptions only, but they were processing huge amounts and distributing them far beyond their authority.

The whole thing is a disaster.

someone can make an extra buck and buy a yacht to store in the Cayman Islands.

http://www.cdc.gov/HAI/outbreaks/meningitis.html

The lab and every single medical office that administered the contaminated steroid certainly can, and will, be held responsible. Criminal charges are different; they rise to a higher standard. I don't know if that will happen, but it might.

I doubt the actual person actually administering the actual injection did NOT know the source of the stuff and was simply following local protocols for med safety.

That means whoever made this stuff and sold it know what the law was. Whoever bought this stuff for use in their institution(s) knew what the law was.

We do too damned much civil suing and too little criminal prosecution in cases like this.

It could very well be the lot was of the diluent or steroid was contaminated at the manufacturer.

Compounding pharmacies don't usually make the pharmaceutical components of the compound.

For example. Let's say they were making cortisone injection in bulk for distribution. They would buy the cortisone from a manufacturer and dilute it with a specific diluent such as bacteriostatic water or sterile water for injection.

I don't have any particular problems with compounding pharmacies. I'm alarmed that this has happened, but I would like more information on where the contamination took place. Was the drug improperly compounded? Were aseptic procedures used? Did someone grab the wrong bottle? Was the source of one of the ingredients contaminated?

I would think that any pharmacy producing bulk compounding services would be required to have a compound log that gives a list of the specific ingredients, amount used, and ndc, lot number, and expiration date of each component.

Too many questions at this point.

In a sense. Most hospitals are compounding pharmacies.

Every time an IV bag is prepared, it is technically a compound. An epidural is usually a compounded IV with an anesthetic and analgesic.

In many cases, a doctor in a hospital can order a compound for a specific circumstance (dye or ingredient allergy, volumes of fluid in the IV, excipients).

Chemotherapeutic compounds are extremely common.

In my experience, there are certain preparations that compounded in hospitals on a regular basis in bulk.

Diaper rash cream is compounded.

Therapeutic mouthwashes are compounded for cancer patients (using both prescription and non-prescription ingredients).

There are some compounding pharmacies that specialize. We have a place in town that compounds specifically for animals. (Mixing drugs with flavorings, dilution to specific strengths that are not manufactured, change of administration form like capsule to tablet or suppository).

Bottom line is that if you dispense a federal legend drug as an ingredient in a compound it is usually prepared by a pharmacy technician whose work is checked by a managing pharmacist.

I'm really not sure what kind of non-regulation they refer to. It is illegal to dispense an FDA regulated prescription drug without a licensed pharmacist.

in times past, it would've fallen under FDA guidelines.

But SCOTUS put the kibosh on that in '02.

They still fall under FDA guidelines.

I've never heard of a compound pharmacy that produces the drugs from scratch.

The word "lab" is something of misnomer.

For example. If they needed to make a Nexium suppository (not that anyone would), they wouldn't whip up their own batch of Nexium from scratch (which would be illegal under FDA and patent laws). They would mix the contents of the Nexium capsule with whatever base they are using to make the suppository.

I want people to be clear on what compounding pharmacies are and aren't. They aren't pharmaceutical makers.

And selling across state line would require them to be licensed to practice pharmacy in the state to which they ship (as well as the state they do the compounding).

oversight of such pharmacies, but the SCOTUS struck it down as unconstitutional...so they basically do what they want...and this is what happens.

They are not regulated in the same way as pharmaceutical companies.

They are regulated as pharmacies.

Different area of regulation.

The products they use are regulated by the FDA.

Any legend drug (prescription drug) is regulated by the FDA.

A compounding pharmacy purchases those drugs from the same place your corner pharmacy does.

They aren't operating in a regulation free zone.

As I said in another post, every hospital with a pharmacy is compounding pharmacy.

But people are blurring the line between pharmaceutical manufacturers and pharmacies in this.

The FDA is responsible for inspecting the quality and safety and the manufacturing facility where they make a birth-control pill.

The State Boards of Pharmacy are responsible for the quality and safety of pharmacy.

In a sense, they are both involved, but the when a pharmacy is inspected they aren't going to open a pack of birth control pills and verify their purity and dosing of the pills in the package. That is what the FDA does at the manufacturing level. The FDA can recall any batch of drugs from a pharmacy, whether it has been contaminated, has some deadly side-effect, etc.

The state board of pharmacy is make sure that properly trained and licensed people are dispensing the medication, keeping appropriate records, and maintaining aseptic procedures (such as keeping the preparation area for the IVs sterile and wearing proper gear to prevent cross contamination).

If, for instance, we find that the lot of the steroid was contaminated, the FDA can and will recall those lots from ALL pharmacies (whether it is compounding or non-compounding pharmacy). Just like they could order ephedra to be taken off the shelf. Compounding pharmacies are not exempt from that.

If, for instance, we find out the compounding pharmacy is responsible due to improper storage or preparation, the State Boards of Pharmacy are responsible for closing the pharmacy or correcting the problem and leveraging any fines/penalties.

It seems complicated, but to say the FDA is not involved, would be incorrect, but not at the same level as a drug manufacturer.

And then, of course, if we start talking about controlled substances which are also compounded with regularity (every hospital that provides epidurals to women in labor is compounding a narcotic and anesthetic), then the FDA, DEA, and Board of Pharmacy is involved at different levels.

The FDA is there to ensure the manufactured product the hospital bought ( vials of fentanyl, lidocaine, normal saline bag, syringes), are safe.

The DEA is there to make sure that controlled substances are dispensed appropriately (in this case the fentanyl) and the proper records are kept.

The board of Pharmacy is there to make sure that the technician is washing their hands, they are not reusing single-use vials or syringes, injecting the proper amount of each substance into the bag, the pharmacist is checking the work for accuracy, that a doctor did order the dispensing, etc...

It is a question of degree and scope of each agency.

So when you hear someone say "The FDA has more oversight of a facility in China than a compounding pharmacy", it is technically correct, but not really telling the whole story.

That said the pharmacy in question was not licensed in the State of Minnesota, and so shouldn't have been distributing compounded medications in the state. Yet, clinics and a surgical center here used the material within MN. The State Attorney General is investigating. It's possible that criminal charges could be filed. More information will come out in time about the investigation.

The bottom line on this is that the fungus should not have been in the compounded material. No way, no how. Every ingredient should have been sterile when combined to form the compounded prescription. Somewhere in the process, that fungus was introduced, probably through lack of proper procedures.

The company that made the stuff will be bankrupt shortly, and its insurance company will be dealing with claims, but coverage probably won't be adequate. Clinics and hospitals that administered it will be sued as well. The actual patients affected, though, won't receive much, if anything, based on those suits, because every outfit is a small corporation and will simply go out of business, only to restart as a new corporation.

This whole thing is a huge clusterfuck, and is not going to turn out well for those who were harmed by it.

Incorporation limits liability to the assets of the corporation. That's the whole point of incorporating, and that's why corporations get to skate so often from their own negligence.