USA Today takes compounders to task

Sunday, March 27, 2005

March 28, 2005

WASHINGTON -  Compounding pharmacies felt the heat of a national spotlight last Thursday when a lengthy critical review of their safety practices wound up in USA Today.
The article, “Safety concerns grow over pharmacy-mixed drugs,” insinuated that compounding pharmacies were “mass-producing drugs without FDA oversight, sometimes making contaminated, ineffective or too potent products.”
One of the article’s opening paragraphs reads: “Because the state-regulated pharmacies are not held to the same quality and safety rules as FDA-regulated drug companies, they don’t have to test their ingredients. And - in the overwhelming majority of states -  they don’t have to check the final products for potency or sterility. Nor are they required to report problems with their drugs.”
This issue of approval and safety was also addressed by a group of doctors and consumer advocates who last week petitioned the FDA to require pharmacy-compounded respiratory drugs to be labeled “not FDA-approved,” according to the story.
The FDA was not available to comment on the petition last week.
Mickey Letson, owner of The Letco Companies, which supplies compounding pharmacies, provided much of the rebuttal in the story to claims of malpractice.
“There has not been one recorded death associated with nebulizer medications, to my knowledge, of the hundred or millions of doses that have been compounded,” Letson was quoted as saying.
In his reaction to the article, Letson took issue with many of the article’s points saying it did not tell the full story. Most notably missing was mention of USP 797, a measure being championed by state boards of pharmacy with specific regulations for compounding pharmacies about drug testing and sterilization standards.