Deaware State Board of Pharmacy Licensing Outsourcing Facilities

Board Licensing Outsourcing Facilities

On June 18, 2014, the Delaware State Board of Pharmacy

unanimously agreed to license “outsourcing pharmacies”

as described under Section 503B of the Federal

Food, Drug, and Cosmetic Act (FD&C Act). On November

27, 2013, the president signed into law the Drug Quality

and Security Act, legislation that contains important

provisions relating to federal and state oversight of compounding

of human drugs. The new legislation creates a

new section 503B in the FD&C Act under which a facility

that compounds sterile drugs can register to become

an “outsourcing facility.” An outsourcing facility can

qualify for exemptions from Food and Drug Administration

(FDA) approval requirements and the requirement to

label products with adequate directions for use, but it still

must comply with current good manufacturing practice

requirements. The registration of pharmacies as outsourcing

facilities will help FDA identify and more effectively

regulate these facilities. FDA intends to continue to partner

with states in the oversight of drug compounding.
quoted from Delaware Board of Pharmacy August 2014 Newsletter