On Friday, March 26, 2021, FDA published a Federal Annals observe,  " Fee rates under the Over-The-Counter Monograph Drug User Fee Program for Fiscal Twelvemonth 2021 ," announcing 2021 fee rates under its over-the-counter (OTC) monograph drug user program.  This is the first year that FDA has collected user fees from OTC drug manufacturers and submitters of OTC monograph lodge requests under its new say-so under the Coronavirus Help, Relief, and Economic Security (CARES) Act.  With limited exceptions, all manufacturers of OTC drugs must pay a facility fee, which exceeds $20,000, past May 10, 2021 (45 days after publication of the notice).

Schedule of Fees

Section 744M of the Federal Food, Drug, and Cosmetic Act (FDCA, 21 U.s.a.C. § 379j-72), every bit added past the CARES Act, authorizes FDA to assess and collect: (1) facility fees from qualifying owners of OTC monograph drug facilities and (2) fees from submitters of certain OTC monograph order requests (OMOR). The fees will support FDA's OTC monograph drug activities, including inspection of facilities associated with OTC products and evaluation of industry-initiated OMORs.

OTC Facility Fee
Manufacturer $twenty,322
Contract Manufacturer $13,548
OTC Monograph Order Request
Tier i $500,000
Tier 2 $100,000

Who Must Pay the Facility Fee?

Two types of OTC monograph drug facilities must pay the 2021 fee—OTC monograph drug facilities (MDF) and contract manufacturing organization (CMO) facilities (including facilities with operations in 2020).

An MDF is a domestic or foreign business or other entity that is engaged in manufacturing or processing the finished dosage course of an OTC monograph drug. See department 744L(10) of the FDCA.   A CMO facility is a MDF where neither the owner—nor whatsoever affiliate of the owner or facility—sells the OTC monograph drug produced at the facility directly to wholesalers, retailers, or consumers in the U.s.. See section 744L(ii) of the FDCA.  CMOs include finished dosage form manufacturers that are in a contractual relationship with the sponsor of ane or more OTC monograph drugs to manufacture or process such drugs.

Fees are due 45 days from publication of the lodge (March 26, 2021), which is May 10, 2021.

Who is Exempted From the Facility Fee?

CMOs that only conduct the activities below are not required to pay a facility fee:

  • manufacture or process clinical inquiry supplies;
  • conduct product testing (g., contract laboratories); or
  • carry "outer packaging" activities for OTC products that are already in last packaged form (g., creating multipacks).

Besides, entities that registered with FDA during the COVID-xix pandemic, whose sole activity with respect to OTC monograph drugs during the pandemic consists (or had consisted) of manufacturing OTC hand sanitizer products, are not considered OTC monograph drug facilities and are not subject to facility fees.

Facilities that ceased OTC monograph drug activities, and updated their registration with FDA to that issue, prior to Dec 31, 2019, likewise are not required to pay.

What are OTC Monograph Social club Request (OMOR) Fees?

In improver to facility fees, the FDA is authorized to appraise and collect fees from submitters of OTC monograph social club requests (OMOR).  An OMOR is a request for an administrative social club from FDA that issues, revises, or amends an OTC monograph.  The OMOR process, implemented nether the CARES Act, replaced the long-continuing monograph rulemaking process that has been subject to scrutiny for decades.  OMORs can exist made by any person marketing, manufacturing, processing, or developing a drug.

Tier 1 OMORs are broadly defined and include whatever OMORs that do not qualify every bit Tier ii OMORs, which include essentially minor changes to existing monographs.  For example, Tier 2 OMORs can include the reordering of existing information in the drug facts label of an OTC monograph drug, the addition of information to the "Other Information" section of the drug facts label (subject to certain limitations), and modification to the "Directions for Use" section of the drug facts characterization of an OTC monograph drug, consistent with a small dosage class change.

OMOR fees are due with the OMOR submission.

Where Can I Find More Information?

More information about facility and OMOR fees, including how to brand electronic payment, can be found on FDA's web site, here: https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/over-counter-otc-drug-review-otc-monograph-reform-cares-deed#omor, and in the March 26 notice.