Legislation that would improve oversight over the country’s compounding
pharmacies is currently making its way through Congress. The House of
Representatives recently passed the Drug Quality and Security Act, which
will now head to the Senate.
While Congress cannot seem to agree on much lately, the bill received support
from both parties and has a strong chance of becoming law. The call for
new regulations follows the widespread meningitis outbreak of last year
in which more than 50 patients died.
“It is because of our collaborative and tireless efforts that we
are near the resolution of last year’s deadly outbreak. To all the
families who have lost loved ones and to those who are still suffering
today, with this bill we say ‘never again,’” said sponsor
Fred Upton (R-MI).
As we have previously discussed on this San Diego Injury Blog, compounding
pharmacies make customized medications for specific patients in doses
or forms not otherwise available. However, the industry has grown in recent
years with many compounding pharmacies producing large shipments of drugs
that are shipped across the country.
The Food and Drug Administration (FDA) currently lacks the authority to
implement strong oversight of compounding pharmacies under current legal
precedent and regulations, leaving licensing of compounding pharmacies
to the states. Under the proposed bill, the FDA would be given greater
authority to regulate these pharmacies, including the establishment of
national standards to trace drugs through the distribution chain.