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Compounding Pharmacy - FDA Registration

A compounder can elect to register with FDA as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b), as added by the Drug Quality and Security Act (DQSA), Pub. Law No. 113-54 (November 27, 2013. After the initial registration, an outsourcing facility must also do so annually for each year thereafter that it wishes to remain an outsourcing facility, during the registration period between October 1 and December 31 of each year.

Registering with FDA as an outsourcing facility

Who can Register

An outsourcing facility engages in the compounding of sterile drugs can register with FDA. Each outsourcing facility at a separate geographic location or address must register separately. The outsourcing facility is not required to be a licensed pharmacy (although it may be a licensed pharmacy), and it may or may not obtain prescriptions for individual patients.

How to Register

Facilities that elect to register with FDA as an outsourcing facility should submit registration information using the existing structured product labeling (SPL) format. The informations required in the SPL file are:

  • Name of the facility
  • Place of business
  • A unique facility identifier
  • Point of contact email address and phone number
  • An indication of whether the facility intends to compound products on FDA's drug shortage list
  • An indication of whether the facility compounds from bulk drug substances, and if so, whether it compounds sterile or nonsterile drugs from bulk drug substances

  • Annual Establishment Fee

    The annual establishment fee is paid at the time of registration and is equal to the sum of $15,000, multiplied by the inflation adjustment factor, plus the small business adjustment factor.The fee calculation is reflected in the following equation:

    Establishment fee = $15,000 x inflation adjustment factor + small business adjustment factor

    Small Business Adjustment Factor

    Certain small businesses can qualify for a reduction of the annual establishment fee. Entities that qualify as small businesses under the FD&C Act are required to pay only one-third of the annual establishment fee, or $5,000 multiplied by the inflation adjustment factor.

    Re-inspection Fee

    The re inspection fee will be equal to $15,000 multiplied by the inflation adjustment factor. The inflation-adjusted re inspection fee for each FY will be published in the Federal Register not later than 60 calendar days before the start of each Financial Year.

    Outsourcing Facility Fees for Fiscal Year 2016

      Qualified Small Business Establishment

      USD 5,203

      Non-Small Business Establishment

      USD 16,465


      USD 15,610

    Product Reporting Procedures

    • The NDC number (National Drug Code) 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
    • The number of individual units produced

    • LMG provide assistance in preparation and submission of SPL files for

      • Compounding Pharmacy Registration with US FDA
      • US FDA Drug Establishment Registration
      • Drug Listing with US FDA
      • NDC Labeler code request to US FDA

      Registered Outsourcing Facilities
Services and Fees

  FDA Registration and   U.S. Agent service

       USD 649        (Annually)

  Drug Listing

       USD 399 /        Drug

  Label Review

       USD 649 /        Drug

  DMF Submission and   U.S. Agent service

       USD 649/        (Annually)

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"Our sincere thanks for helping us in preparing the SPL file and completing drug listing with FDA."

Benedict, India

"Greetings from Los Angeles. Much thanks and regards to help us to finalize our electronic FDA submission"

Paul, Los Angeles

"Wonderful job, you did it so quickly."

Nervaliz, Israel