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
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