The
legislation would draw a distinction between traditional compounding pharmacies
and those such as NECC which ship sterile products across state lines. These
larger organizations, to be known as "outsourcing facilities," would
be regulated by the FDA but be exempt from the full spectrum of regulations
that apply to traditional pharmaceutical companies. An outsourcing
facility is free to choose whether it will (i) be state licensed as a pharmacy
or not; and (ii) obtain prescriptions for identified individual patients and/or
prescribe for unlimited office use. A potentially-critical prohibition,
however, is applied to outsourcing facilities, in that will only be permitted
to compound from bulk API, as opposed to commercially available drugs, that
appear on an affirmative, finite list to be established by HHS.
For full text of the
Drug Quality and Security Act, please click here.
For more
information, please click here.
The act passed the House on September 28, 2013, but has not
yet received a Senate vote.
If you would like more information, please contact Laura
Tepich at ltepich@kdlegal.com.