Wednesday, June 19, 2013

Texas Lawmakers Approve Money for More Inspectors

New state inspectors target compounding pharmacies

Lawmakers approve money for more inspectors

Updated: Tuesday, 18 Jun 2013, 6:40 PM CDT
Published : Tuesday, 18 Jun 2013, 6:29 PM CDT
Austin (KXAN) - Pharmacists and technicians at theDripping Springs Compounding Center measure every gram and every ounce of medication with precise care.  They mix each prescription with one patient in mind. 

"Everybody's body is different, and you react differently to different things," said compounding pharmacy customer Beth Ann Matlock.  "So I think the compounding is really the way to go.  It's specifically made for the individual."
Nancy Niland turned to compounding when her 14 year old cat Buster got very sick and would not take a pill.   

"I went to the compounding pharmacy here, and they compounded a triple fish liquid that I was able to give him in an eye dropper," said customer Nancy Niland.  "He loved it, and it literally saved his life."
Compounders also can adjust the dosage of a drug to fit a patient's needs or put it in a form the patient is able to take.  Compounders make medicine that drug manufacturers have stopped making.
"There are hundreds of drugs that are in short supply or not available now, and we have to fill that gap," said Dripping Springs compounding pharmacist Jim Martin.
The Food and Drug Administration is closely watching compounding pharmacies right now.  The agency's target is not traditional compounding pharmacies like the one in Dripping Springs but those making big batches of drugs and shipping them to doctors often across state lines.  They act more drug manufacturers making medicines before a prescription is written for any patient.
The Texas State Board of Pharmacy will soon inspect compounding centers more frequently with five new inspectors. They have seven now. State lawmakers approved the money for the new inspectors during the 2013 legislative session.
The national and state scrutiny was brought on last fall after a  compounding center in Massachusetts sent thousands of contaminated doses of pain injections to about two dozen states.   More than 50 Americans died from fungal meningitis. 

"These types of preparations are extremely critical, because they're injected into the patient's bloodstream," said Director of Enforcement for the Texas State Board of Pharmacy Carol Fisher.  "So any kind of mishap can be fatal."
The Board of Pharmacy hopes to hire the new inspectors early next year adding another layer to the effort to keep Texas families safe.

Inspection in Central Texas
The FDA and State Board of Pharmacy recently inspected a Cedar Park compounding facility that supplies medicine to People's Pharmacies in Austin and other doctors.  The facility is Specialty Compounding, LLC.
Other state action
Texas Senator Van de Putte authored a law that sets up requirements for out-of-state pharmacies that  compound sterile drugs for Texas patients and facilities.  Those out-of-state pharmacies will now have to go through an inspection prior to being able to do business in Texas.  Texas State Board of Pharmacy inspectors may travel to that state to look closely at the center.
National legislation
The United States Senate is considering a bill to give the FDA more regulatory power over some compounding pharmacies -- those that operate more like drug manufacturers.  Those compounders make sterile drugs without a prescription and sell them to doctors across state lines.  The bill would require they register with the FDA and be ready for regular inspections.  The House is looking at a similar bill.

quoted from here

No comments: