Federal Drug Quality and Security Act
Brings Changes to Pharmaceutical
Compounding Practices
On November 27, 2013, President Barack Obama signed
into law the Drug Quality and Security Act (DQSA). DQSA
focuses on two broad issues: (1) further refinement of the state
and federal roles in regulating compounding pharmacy practices
and (2) creation and implementation of a national “track and
trace” program intended to ensure integrity of the prescription
drug supply chain.
Regarding the compounding of pharmaceuticals, the large
change is the addition of a business class now referred to as
“outsourcing facilities.” The law defines an “outsourcing facility”
as a facility at one geographic location or address that is
engaged in the compounding of sterile drugs; has elected to
register as an outsourcing facility; and complies with all of the
requirements of the new law (Section 503B).
An outsourcing facility can qualify for exemptions from the
Food and Drug Administration (FDA) approval requirements
and the requirement to label products with adequate directions
for use, but not the exemption from current Good Manufacturing
Practices (cGMPs) requirements. Outsourcing facilities:
♦♦must comply with cGMP requirements;
♦♦will be inspected by FDA according to a risk-based schedule;
and
♦♦must meet certain other conditions, such as reporting adverse
events and providing FDA with certain information
about the products they compound.
For retail or hospital pharmacies that conduct compounding,
the recently passed law will likely not cause much change in their
processes. The requirement to compound based on a patientspecific
prescription or order is still a basic tenet for pharmacies
to follow. The only exception is compounding a product “for
office use,” which is defined as only use within the practitioner’s
office and prohibited from being dispensed to a patient.
Should you have any questions from your practice setting,
please feel free to give the Board a call to discuss.
quoted from here
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