Compounding Hits the Headlines as Coalition Calls for Stronger Oversight

WASHINGTON–The day before a consumer coalition filed a petition
with the Food and Drug Administration advocating stronger oversight
of compounding pharmacies, the issue hit the headlines in a
front-page story that ran last week in USA Today.

“When you can know more about a box of Cheerios than you can
about products some of these pharmacies are making, that’s wrong,”
Nancy Sander told the national newspaper in a story published March
23. Sander heads the Allergy & Asthma Network of Mothers of
Asthmatics, which spearheaded the consumer effort calling on the
FDA to address the mass production of unapproved drugs.

The Consumer Health Alliance for Safe Medication (CHASM), a
coalition of patients, nurses, physicians and respiratory
therapists, wants to make sure that respiratory patients “have
access to safe and effective medications and are protected from
products that may pose unwarranted risks,” according to a press
release from the group.

“Consumers generally believe that all prescription medications
are approved by the FDA as safe and effective. However, an
increasing number of pharmacy businesses are manufacturing,
promoting and dispensing unapproved respiratory drugs as
substitutes for FDA-approved medications. Without their knowledge,
patients with asthma, emphysema and other respiratory conditions
are increasingly exposed to unnecessary health risks associated
with these medications,” Sander said in the release.

The USA Today article also detailed safety concerns
regarding pharmacy-mixed drugs. “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,” the article said, adding that in a majority of
states, pharmacies don’t have to check the final products for
potency or sterility, or “to report problems with their drugs.”

In the article, Mickey Letson, president of Decatur, Ala., drug
distributor The Letco Companies, responded, saying, “There has not
been one recorded death associated with nebulizer medications, to
my knowledge, of the hundreds of millions of doses that have been
compounded.”

At issue, observers say, is jurisdiction. Traditionally,
pharmacy boards have had jurisdiction over compounding pharmacies
while FDA has held oversight over manufacturers.

But Lisa Smith, a health attorney with Amarillo, Texas-based
Brown & Fortunato, said that safety concerns have been
addressed by rules already in place. Since January of 2004, the FDA
has been able to enforce safety standards set by the United States
Pharmacopeia, an independent standards organization. Some state
pharmacy boards have adopted similar standards, she said, along
with accrediting bodies like the Joint Commission on Accreditation
of Healthcare Organizations (JCAHO).

“These requirements do address end-product testing for sterility
and potency,” Smith said, “which are the primary concerns of [the
coalition].”