Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs

Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs

DATES:

Submit electronic comments on the proposed administrative order by October 3, 2025.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of the proposed order OTC000038 pursuant to section 505G(c) of the FD&C Act (21 U.S.C. 355h(c)), which specifies FDA's proposed requirements for making a minor change in the dosage form of certain OTC monograph drugs, without the issuance of a separate order under section 505G(b) of the FD&C Act amending an applicable monograph to add the new dosage form or otherwise finding the new dosage form to be GRASE. Section 505G(c) of the FD&C Act applies to drugs described in section 505G(a)(1) or (a)(2) of the FD&C Act or that are otherwise the subject of an order under section 505G(b). More specifically, section 505G(c)(3) of the FD&C Act directs FDA to issue one or more administrative orders specifying the requirements for determining whether a minor dosage form change to a drug made by a sponsor pursuant to section 505G(c) of the FD&C Act will affect the safety or effectiveness of the drug or materially affect the extent of absorption or other exposure to an active ingredient in the drug in comparison to a suitable reference product.

This proposed order also fulfills a commitment made by FDA under the terms of the "Over-the-Counter Monograph User Fee Program Performance Goals and Procedures," commonly referred to as the OMUFA commitment letter (the document can be accessed at https://www.fda.gov/media/106407/download and the document with the updated goal dates for fiscal years 2021 to 2025 can be accessed at https://www.fda.gov/media/146283/download ). The OMUFA commitment letter specifies goals and timelines mutually agreed upon by FDA and industry with respect to various OTC monograph drug activities conducted by FDA. FDA committed to issuing a proposed order outlining key requirements to clarify which types of minor changes to solid oral dosage forms are permissible without the issuance of an order finding the new dosage forms to be GRASE (when the applicable OTC monograph does not already provide for these types of changes), together with related draft guidance (FDA is publishing notice of the draft guidance for industry "Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs" elsewhere in this issue of the Federal Register ).

Consistent with section 505G(c)(3) of the FD&C Act, FDA proposes to specify the requirements for determining whether a particular minor dosage form change to a drug made by a sponsor pursuant to section 505G(c) will affect the safety or effectiveness of the drug or materially affect the extent of absorption or other exposure to an active ingredient in the drug product in comparison to a suitable reference product. This proposed order specifies these requirements for when the minor dosage form change is from a tablet or capsule dosage form to one of the following dosage forms: chewable tablet, ODT, or film. The proposed order, if finalized, will permit these minor changes in the dosage form of OTC monograph drugs that are both highly soluble and highly permeable and in conformity with the requirements of the order, section 505G(c) of the FD&C Act, and other applicable requirements, without the issuance of a separate order under section 505G(b) of the FD&C Act to amend the applicable OTC monograph to add the new dosage form or otherwise find the new dosage form to be GRASE.

FDA plans to separately consider minor changes in dosage form under section 505G(c) of the FD&C Act from tablets or capsules to chewable tablets, ODTs, or films for OTC monograph drugs with active ingredients that are not both highly soluble and highly permeable ( i.e., drugs that have: (1) low solubility and high permeability; (2) high solubility and low permeability; and (3) low solubility and low permeability). In the future, FDA plans to issue a separate notice announcing a request for information that would seek comments on minor changes in dosage form under section 505G(c) of the FD&C Act for these types of drugs. Any comments on minor changes in solid oral dosage forms under section 505G(c) for OTC monograph drugs that are not both highly soluble and highly permeable that are submitted to the docket for this proposed order (OTC000038) will be considered outside the scope of this proposed order and will not be considered as part of a finalization of proposed order OTC000038.

As we develop any final order on this topic, FDA will consider comments on the applicability of Executive Order 14192, in particular, on any costs or cost savings.

The proposed order can be viewed in the OTC Monographs@FDA portal at https://dps.fda.gov/omuf. The proposed order contains instructions for commenting on the proposed order. Comments to the proposed order must be submitted electronically to the Federal eRulemaking Portal https://www.regulations.gov.

OTC Monographs@FDA provides a resource for the public to view administrative orders (proposed, final, and interim final orders) for OTC Monograph Drugs and view OTC Monographs. In the future, OTC Monographs@FDA will facilitate the public's ability to submit, search, and view comments and data for proposed, final, and interim final orders.

II. Paperwork Reduction Act of 1995

This proposed order contains no collections of information that are subject to clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The proposed order is issued under section 505G(c) of the FD&C Act. Under section 505G(o) of the FD&C Act, the PRA does not apply to collections of information made under section 505G of the FD&C Act. Moreover, the labeling changes proposed in this order are excluded from the definition of "collection of information" under the PRA by 5 CFR 1320.3(c)(2), which states that "The public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public is not included within this definition." Therefore, clearance by the Office of Management and Budget under the PRA is not required for collections of information, if any, in a final order issued under section 505G of the FD&C Act that results from this proposed order.