What does it mean to be registered as a human drug compounding outsourcing
facility under section 503B?
Registration means only that FDA has received the information
required to register the facility. It does not mean that the
facility is making FDA-approved drugs and it does not mean it is in compliance
with current good manufacturing practice requirements, the other conditions of
section 503B, or other requirements in the Act. Approval of a drug requires the
submission and approval of a new drug application or an abbreviated new drug
application. Facilities registered as human drug compounding outsourcing
facilities are required to comply with current good manufacturing practice
requirements; report adverse events to FDA; label their products with certain
information; and meet certain other requirements if they are to qualify for the
exemptions from the new drug approval and adequate directions for use
requirements of the Act. Outsourcing facilities that comply with the conditions
for exemption under section 503B are not required to obtain new drug
approvals. Listing of an outsourcing facility on this list does
not mean that FDA has determined that the outsourcing facility is
in compliance with these requirements or that it has met the conditions to
qualify the exemptions under section 503B.
quoted from here
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