Human Drug Compounding Registration And Product Reporting Procedures

Notice To All 503B Outsourcing Facilities
Product Reporting Technical Problem

The Agency has  finalized guidance, Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM424303.pdf. Therefore, starting June 2017 reporting period the Agency is requiring that outsourcing facilities submit reporting data electronically in Structured Product Labeling (SPL) format.

Registered outsourcing facilities must submit a report upon initial registration under section 503B of the FD&C Act and twice each year thereafter, once in June and once in December. Semiannual drug product reports submitted between June 1 and June 30 of each year must report products produced during the previous six month period from December 1 through May 31. Semiannual reports submitted between December 1 and December 31 of each year must report drug products compounded during the previous six month period from June 1 through November 30.

This report must identify all sterile and non-sterile drugs compounded at the outsourcing facility during the previous six-month period and provide all of the following information for each compounded drug:

  • The active ingredient and strength of active ingredient per unit
  • The source of the active ingredient
  • The 10-digit National Drug Code (NDC) number of the source drug or bulk active ingredient, if available
  • The dosage form and route of administration
  • The package description
  • The number of individual units produced
  • The NDC number of the final product, if assigned

Although each compounded product could be reported in a separate SPL submission, techniques can be used to simplify and combine the submissions for products with identical active ingredients, different packaging presentations, formulations, and/or strengths. Multiple strengths, package sizes, and source NDC numbers can be reflected in a single SPL submission, which will reduce the number of SPL submissions that a facility will need to submit to FDA.

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.

When registering, 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: 02/03/2017
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