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 with FDA

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 with FDA

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 FDA 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.

An entity with gross annual sales totaling $1,000,000 or less in the 12 months ending on April 1 of the fiscal year immediately preceding the fiscal year in which the annual establishment fee is assessed may qualify for a small business reduction.

Entities that seek a small business reduction of the annual establishment fee must make a request for such a reduction by April 30 of the year preceding the fiscal year for which the entity is seeking a reduced fee.

FDA 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.

FDA Outsourcing Facility Fees for Fiscal Year 2025

Small Business Establishment	USD 6,488
Non-Small Business Establishment	USD 21,534
Re-inspection	USD 19,465

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