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Outsourcing Facilities Must Register and Report Drug Products to FDA by December 31

[:en]Outsourcing facilities must complete their annual registration with the U.S. Food and Drug Administration (FDA) between October 1 and December 31, 2015. The fee to register for fiscal year 2016 is $16,465.  The fee for small businesses is $5,203.

Outsourcing facilities must also submit drug product reports to FDA between December 1 and 31, 2015, for all drugs produced in the preceding 6-month period (June 1 through November 30, 2015). The report must include the following for each compounded drug:

  • The active ingredient and strength of active ingredient per unit
  • The source of the active ingredient (bulk or finished drug)
  • The 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

Outsourcing facilities must submit drug product reports upon registering with FDA and then annually in June and December.  Usually FDA requires that drug product reports be submitted electronically in Structured Product Labeling (SPL) format unless granted a waiver.  However, for the June 2015 reporting period, FDA asked outsourcing facilities to email their reports to FDA in an Excel spreadsheet due to a technical issue with the agency’s electronic reporting system.  It is unclear at this time whether FDA’s electronic reporting system will be prepared to accept submissions in December 2015.  We will keep industry updated.

Registrar Corp can submit drug product reports to FDA, whether in spreadsheet form or SPL format, quickly and properly.  Registrar Corp can also register outsourcing facilities with FDA and facilitate payment of the necessary fees.  For assistance, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

For more information about registration, fees, and reporting requirements for outsourcing facilities, click here.[:es]Outsourcing facilities must complete their annual registration with the U.S. Food and Drug Administration (FDA) between October 1 and December 31, 2015. The fee to register for fiscal year 2016 is $16,465.  The fee for small businesses is $5,203.

Outsourcing facilities must also submit drug product reports to FDA between December 1 and 31, 2015, for all drugs produced in the preceding 6-month period (June 1 through November 30, 2015). The report must include the following for each compounded drug:

  • The active ingredient and strength of active ingredient per unit
  • The source of the active ingredient (bulk or finished drug)
  • The 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

Outsourcing facilities must submit drug product reports upon registering with FDA and then annually in June and December.  Usually FDA requires that drug product reports be submitted electronically in Structured Product Labeling (SPL) format unless granted a waiver.  However, for the June 2015 reporting period, FDA asked outsourcing facilities to email their reports to FDA in an Excel spreadsheet due to a technical issue with the agency’s electronic reporting system.  It is unclear at this time whether FDA’s electronic reporting system will be prepared to accept submissions in December 2015.  We will keep industry updated.

Registrar Corp can submit drug product reports to FDA, whether in spreadsheet form or SPL format, quickly and properly.  Registrar Corp can also register outsourcing facilities with FDA and facilitate payment of the necessary fees.  For assistance, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

For more information about registration, fees, and reporting requirements for outsourcing facilities, click here.





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