Compounding Pharmacy Registration

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.

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 registration with FDA

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.

Liberty Management Group LTD, one of the leading FDA consulting group in the USA, can assist you with register your facility with FDA, LMG will help you with SPL preparation and submission to FDA, Drug establishment registration, drug listing and provide US Agent service to foreign facilities.

OutsourcingFacility Fees for Fiscal Year 2016