Thursday, March 6, 2014

North Dakota Board of Pharmacy Explains the DQSA

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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