SAFETY
3 8
O U T P AT I E N T S U R G E R Y M A G A Z I N E O N L I N E | J U LY 2 0 1 4
disclose which medications they produced.
Thankfully, that's changed. Last November, in response to the NECC
tragedy, President Obama signed the Drug Quality and Security Act
(DQSA), which clarified and in some instances increased FDA's control
of drug compounding. The DQSA places sterile compounding pharma-
cies that ship sterile products across state lines without a patient-spe-
cific prescription under the jurisdiction of the FDA. The FDA can
demand that those pharmacies release detailed information about their
operations and give it greater authority to require safety problems be
fixed.
The DQSA even goes a step further with an added level of scrutiny.
Compounding pharmacies can voluntarily register with the FDA and
be considered a "503b outsourcing facility." Compounding facilities
that are voluntarily registered must inform the FDA about drugs they
develop, investigate and report adverse events, and include a label that
indicates the drugs were compounded. They must also comply with
good manufacturing practice requirements enforced by the FDA.
The FDA sent thousands of letters to hospitals calling on them to
encourage compounding pharmacies to register with the agency. Of
the 700 to 1,000 compounding pharmacies, about 50 are registered
outsourcing facilities (view the list at
tinyurl.com/mddyfsm
).
Develop a relationship
Beyond sterility concerns, here are some strategies you can take to
ensure a good working relationship with your compounder:
Work with people you know and trust. Think of partnering with a
compounding pharmacy as collaborating with another healthcare pro-
fessional. Look for a compounder in your ZIP code or close to it.
When the next bupivacaine recall hits, you can turn to the com-
pounder you know on a first-name basis and keep your syringes and
OSE_1407_part1_Layout 1 7/3/14 9:00 AM Page 38
