On November 21, 2014, the U.S. Food and Drug Administration (FDA) published three guidance documents for outsourcing facilities: one regarding registration, one regarding fees, and one regarding drug product reporting. FDA 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 section 503B.”
The option to become an outsourcing facility was added to the Food, Drug, and Cosmetic (FD&C) Act in November 2013. Outsourcing facilities may qualify for some exemptions from FDA drug regulations, such as approval and labeling requirements. Outsourcing facilities must still comply with Current Good Manufacturing Practices (CGMP), FDA inspections, adverse event reporting, and reporting information about the drugs being compounded.
Registering Outsourcing Facilities (Final Guidance)
Every outsourcing facility at a separate geographic location or address must have a separate registration. Outsourcing facilities may be, but are not required to be, licensed pharmacies, and they may or may not obtain prescriptions for individual patients.
Outsourcing facilities can register with FDA by creating and submitting information in a structured product labeling (SPL) file under the category “Human Drug Compounding Outsourcing Facility.” The file should include the following information:
- The facility’s name
- The place of business
- The Unique Facility Identifier
- An e-mail address and phone number for a point of contact
- An indication of whether the facility intends to compound products on FDA’s drug shortage list
- An indication of whether the facility compounds sterile or non-sterile drugs (or neither) from bulk drug substances
Unless FDA grants a request for waiver, the outsourcing facility registration must be submitted electronically. Once the initial registration is complete, the facility must register each year between October 1 and December 31 in order to maintain its status as an outsourcing facility.
FDA is required to publish a list of registered outsourcing facilities on the Internet, which the agency intends to update weekly. The list includes each facility’s name, the date it registered, the state the facility is located in, and whether it compounds from bulk drug substances (and if so, whether they’re sterile or non-sterile drugs). FDA also includes certain information regarding previous inspections and compliance actions in the list.
Fees for Outsourcing Facilities (Final Guidance)
A facility will not be considered registered until its annual establishment fees are paid. Even if a facility initially registers as an outsourcing facility outside of the annual registration period, it will still have to pay the full establishment fee. FDA will invoice a facility for the fees upon receipt of a registration submission.
Small businesses may qualify for an establishment fee reduction. FDA defines a small outsourcing facility business as “an entity with gross annual sales totaling $1,000,000 or less in the 12 months ending on April 1 of the FY immediately preceding the FY in which the annual establishment fee is assessed may qualify for a small business reduction.” Gross annual sales include all worldwide sales of the facility and its affiliates, not just sales in the United States, and includes all of the products sold, not just drug sales.
In order to qualify, an outsourcing facility must submit to FDA a written request for the fee reduction and a certification that shows it meets the definition of a small business. This information must be submitted annually, no later than April 30 of the year preceding the fiscal year (FY) for which the reduction is sought.
Outsourcing facilities are also subject to reinspection fees. Routine FDA facility inspections are free of charge, but if FDA identifies noncompliance during an inspection and decides it must return to assess if the compliance status has changed, FDA can charge reinspection fees. There is no reduction in reinspection fees for small businesses.
FDA will publish the specific fee rates for each FY in the Federal Register 60 or more days before the start of that FY. The fees are calculated as follows:
- Establishment fee: $15,000 USD, multiplied by the inflation adjustment factor for that FY, plus the small business adjustment factor for that FY.
- Small business establishment fee: $15,000 USD, multiplied by the inflation adjustment factor for that FY, divided by three.
- Reinspection fee: $15,000 USD, multiplied by the inflation adjustment factor for that FY.
Facilities have 15 days after FDA issues a registration invoice to pay the full amount. If a facility does not pay, FDA will consider the registration submission to be withdrawn, and drugs that the facility manufactures, prepares, propagates, compounds, or processes will be deemed misbranded until it is reregistered. As for reinspection fees, facilities have 30 days to remit payment. If reinspection fees are not paid in full within 30 days of being invoiced, FDA will treat the fee as a claim of the U.S. Government subject to interest and other fees. There are no refunds for outsourcing facility fees.
Electronic Drug Product Reporting for Outsourcing Facilities (Revised Draft Guidance)
An outsourcing facility must submit a drug product report to FDA upon its initial registration and again in June and December of each year. The report must list every drug compounded at the facility during the previous six months and provide the following information about each one:
- The active ingredient, along with the ingredient’s strength per unit and source (bulk or finished drug)
- The dosage form and route of administration
- The package description
- The number of individual units produced
- The National Drug Code (NDC) number of the source drug or bulk active ingredient and of the final product, if available
Drug reports should be created in SPL format as a “Human Compounded Drug Label” document. As with registration submissions, drug reports must be submitted electronically unless FDA grants a waiver request.
Registrar Corp assists drug companies with FDA regulation compliance. We can register a facility as an outsourcing facility and report its drug products to FDA using the correct SPL format. If you have any questions regarding FDA’s requirements for outsourcing facilities or FDA’s other drug regulations, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor at any time by using the Live Help service: https://www.registrarcorp.com/livehelp.