Written by, Regulatory specialist, LMG, Published on 8-26-2015
Compounding is a preparation in which a licensed pharmacist or physician, or, in the case of an outsourcing facility, a person under the guidance of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication custom-made to the needs of an individual patient.
Compounding is a preparation in which a licensed pharmacist or physician, or, in the case of an outsourcing facility, a person under the guidance of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication custom-made to the needs of an individual patient.
Compounded
drugs are not FDA-approved, FDA does not verify the safety, or
efficiency of compounded drugs. State boards
of pharmacy will continue to have major responsibility for the day-to-day
oversight of state-licensed pharmacies that compound drugs in agreement with
the conditions of section 503A of the FDCA, although FDA retains some influence
over their operations. But, outsourcing facilities that register under section
503B are regulated by FDA and must fulfil the CGMP requirements and will be
inspected by FDA according to a risk-based schedule.
An
“outsourcing facility” is the place where they compound the sterile drugs.An
outsourcing facility can qualify for exceptions from the FDA approval
requirements and the condition to label products with adequate directions for
use, but not the exclusion from current good manufacturing practice (CGMP)
requirements.
Outsourcing facilities:
· Must comply with CGMP requirements;
· Will be inspected by FDA according to a risk-based schedule
· Must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.
Outsourcing
facility can register with FDA using electronic drug registration system.
If the
facilities engages compounding sterile human drugs they may register withFDA as an Outsourcing facility.
If the
facility engages in repacking human drugs, mixing, diluting or repacking
biological products, compounding non-sterile drugs and compounding animal drugs
do not need to register as an outsourcing facility since the drugs it produce
will not be eligible for the exemptions as in 503B of FD&C Act.
