Before Meningitis Outbreak, Concern at F.D.A. Over Compounders

From the article:

only two states that randomly test compounded drugs, Texas and Missouri, significant problems have surfaced.

In Texas, a hub of compounding pharmacies, random tests by the state’s pharmacy board over the last several years found that as many as one in four compounded drugs was either too weak or too strong. The testing results are just slightly better in Missouri. Potency varied by as much as 300 percent in the Missouri tests.

SUPER POTENT, SUBPOTENT… a variance of up to 300% — WTF?

If compounding is suppose to be our forte…  what the hell are we doing… delegating this to techs… who do not know what the hell they are doing and we are not taking the time to give them even a modest amount of  training or supervision ? If this is RPH’s who are personally doing this kind of work… where did they get their license… at a BLUE LIGHT SPECIAL ?

From the article:

Records analyzed by The New York Times show that in 62 cases over the last decade, the F.D.A. blocked the importation of drugs for use in compounding; nearly half were from China, one of the largest producers of raw pharmaceutical ingredients, where many manufacturers operate outside the regulatory net.

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After a pharmacist in Kansas City, Mo., pleaded guilty to watering down chemotherapy drugs, the Missouri Board of Pharmacy began in 2006 randomly sampling compounded drugs. In 2008, one in four samples failed a potency test. The failure rate dropped to 15 percent in 2010, the most recent year available.

The Texas State Board of Pharmacy started its own random testing program after seeing what Missouri had done. That state’s failure rate has generally hovered between 20 percent and 25 percent.

Once again… where is the National Association Boards of Pharmacies ??? Isn’t this group suppose to provide leadership collectively for all the BOP’s… where is the “model bill/law”… for state BOP’s to take back to their legislatures…. to have better oversight of this activity?  Let’s not forget the APHA

I got one email from NCPA about this… nothing from my state association… 24 cases of meningitis and one death… Nothing on their Linkedin page, nothing on their website, Facebook page NOTHING… so I checked the BOP’s Facebook page… and here is their – at least publically – involvement and concern…

Given the recent meningitis outbreak tied to a compounding pharmacy in Massachusetts, the Board of Pharmacy reminds you that practice act states that qualifying pharmacists shall “be responsible for adherence to all current

Filed under: General Problems