Wednesday, August 26, 2015

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 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

Tuesday, June 16, 2015

FDA Regulations for API

written by: FDA regulatory specialist Published on 6-6-2015

What is API

Active Pharmaceutical Ingredient is a product which is not intended to consume directly by human.
Drugs which does not have enough information on the label regarding how to consume is also considered as API.
API are involved in the manufacturing of finished drugs.

Regulations for API with FDA

All domestic and foreign API Manufacturers have to register their facility or establishment with FDA.
All API should possess a NDC number which is unique for each API.
All API imported inside US must be listed with FDA.
Self-Identification is required for all domestic and foreign facility where API for generic drug is manufactured.
All foreign API manufacturers should have an U.S.Agent.

 Services provided by LMG for API manufacturers.

LMG assists API manufacturer to electronically submit Self-identification, facility registration, NDC labeler code and drug listing.

LMG provides US Agent service for foreign API manufacturers.


Certificate of Free sale, which is also known as FDA Export Certificate is a document which certifies that the product manufactured in US is eligible for export. This certificate states that there are no overheads or pending impulsive actions on the manufacturer. This is a document which contains information about a product’s regulatory and marketing status.
           This Certificate of free sale or export certificate is needed by many foreign governments because they want to ensure that the products marketed in their country comply with US FDA regulations. This is issued by the FDA upon request by the manufacturer which meet the FDA regulations. 
           The certificate of free sale is for food including dietary supplements and cosmetics. FDA export certificate is for human drugs, animal drugs and medical devices that meet up with the FDA standards and the manufacturers should follow the cGMP.
       FDA will not issue the Certificate of free sale or export certificate, if the product is not exported from US. Manufacturers has to register their facility with FDA before they apply for the Certificate of free sale from FDA.

Liberty Management Group Ltd, US based leading FDA Consulting group can guide you through the export certificate request process, which will help you to get the process easier. LMG also provide assistance with facility registration with FDA.

written by : FDA Registration Specialist, LMG
Published on : 6-16-2015

Thursday, October 9, 2014

Friday, August 1, 2014

FDA Announces Medical Device User fee for FY 2015

The annual establishment registration fee must be paid between October 1, 2014 and December 31, 2014. For FY15, the registration fee for each establishment is $3,646 

                                     FY15 User Fees (in U.S. Dollars)

application type
standard fee
small business fee
panel-track supplement
180-day supplement
real-time supplement
BLA efficacy supplement
annual report
30-day notice

Thursday, October 10, 2013

FDA Activities are limited due to government shutdown

FDA activities are limited from October 1, 2013, and continuing until the date of enactment of  FY 2014 appropriation.

Drug Registration

Even though the activities are limited FDA is accepting SPL submission for Drug establishment registration, Drug listing and NDC Labeler code request. But the NDC Labeler code assignment may be delayed.

Food Facility Registration.

The food facility registration and prior notice modules are working fine during the lapse period

Medical Device Registration

FDA is not collecting the Establishment registration fee for the year 2014, which may affect the registration and listing of new medical device and renewal of existing registrations.

FDA is not accepting 2014 medical device user fees for regulatory submissions like 510 (k) for 2014 fiscal year which may affect the new submission to FDA.

Friday, January 25, 2013