Drugs

Human Drug Compounding Registration And Product Reporting Procedures

 

Notice To All 503B Outsourcing Facilities
Product Reporting Technical Problem

Due to a continuing technical problem, the Food and Drug Administration (FDA) is not prepared to accept product reports from 503B outsourcing facilities for the December 2014 through May 2015 reporting period via Structured Product Labeling.  As a result, to satisfy the June 2015 product reporting requirement in section 503B(b)(2) of the Federal Food, Drug, and Cosmetic Act,  outsourcing facilities should submit reporting data to FDA in an Excel spreadsheet via an email attachment (see the draft guidance, Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act).  Reports must include drug products compounded during the six month period from December 1, 2014 through May 30, 2015. Product reports should be submitted to edrls@fda.hhs.gov.  Section 503B requires outsourcing facilities to submit product reports for this reporting period between June 1, 2015 and June 30, 2015 to satisfy their product reporting obligation.

 
For each drug identified in a product report, the outsourcing facility must provide the following information:
  • The National Drug Code (NDC) number of the final product, if assigned
  • The active ingredient and strength of active ingredient per unit;
  • The National Drug Code number of the source drug or bulk active ingredient, if available;
  • The source of the active ingredient;
  • The dosage form and route of administration;
  • The package description; and
  • The number of individual units produced;
 
Attached is an Excel template that you can use for your report.
 
FDA will review each product report upon receipt and contact you if we have any questions.

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: 06/03/2015
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