Drugs

Human Drug Compounding Registration And Product Reporting Procedures

 

Notice To All 503B Outsourcing Facilities
Product Reporting Technical Problem

Due to a technical problem with the product reporting system, outsourcing facilities are currently unable to send Source NDC data in the HUMAN COMPOUNDED DRUG LABEL document type when submitting 503B product reports using FDA’s drug registration and listing system. Therefore, at this time, outsourcing facilities do not need to provide the Source NDC for active ingredients when submitting product reports for the June 2014 - November 2014 reporting period.

Outsourcing facilities that use CDER Direct to complete their product reports should choose/use “Active Ingredient, Ingredient is the Basis of Strength” as the ingredient type for their active ingredients when completing the product report. The Source NDC field will not appear, and outsourcing facilities should fill out the rest of the ingredient information as appropriate.

Outsourcing facilities that use alternate methods to generate and submit Structured Product Labeling (SPL) product reports should make whatever changes are necessary to identify all active ingredients, but need not provide the Source NDC for active ingredients when submitting product reports for the June 2014 - November 2014 reporting period.

For additional information, please refer to FDA’s guidance documents concerning 503B registration and product reporting.


The Drug Quality and Security Act (DQSA) adds new section 503B to the Federal Food, Drug & Cosmetic Act (FDCA). Under section 503B, a compounder can register as an “outsourcing facility.” The law defines an “outsourcing facility” as a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of this section. Registered outsourcing facilities must submit information about their products to the FDA at the time of registration and twice each year after initially registering.
 
FDA has published draft guidances on registering and reporting product information for those entities that intend to register as outsourcing facilities. Further information can be found at the links below. 
 
When registering using the electronic system, please note the FDA has created a new category of business operation called “Human Drug Compounding Outsourcing Facility.” Facilities registering pursuant to 503B should use this operation.
 
Related Resources

 

Page Last Updated: 12/24/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.