In a pre-publication notice in the Federal Register today, the FDA published OTC manufacturing facility fees for Fiscal Year 2026. The fees are due on June 1, 2026. There are two types of OTC manufacturing facilities outlined in the statute:

  • First is the OTC Manufacturing Drug Facility (MDF), which is described as “a foreign or domestic business or other entity that, in addition to meeting other criteria, is engaged in manufacturing or processing the finished dosage form of an OTC monograph drug.”
  • Second is the Contract Manufacturing Organization (CMO), which is described as “an OTC monograph drug facility where neither the owner nor any affiliate of the owner or facility sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States.”

The MDF pays a full fee and the CMO pays two-thirds of the fee. The fees for FY 2026 and the previous year appear in the table below.

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As you likely note, the facility fees dropped significantly. This implies that the number of OTC manufacturers registered with the FDA has increased significantly!

If you are an OTC manufacturing facility, get those checkbooks ready as June 1st is fast approaching, but at least this year it won’t dent your checking account balance as much as last year.

The Federal Register pre-publication notice explaining how the fees were calculated can be found here.