FDA Issues Proposed Order to Facilitate Minor Changes to Solid Oral Dosage Forms to OTC Monograph Drugs, but Such Changes May Come at a Price

On June 5, 2025, FDA announced two proposed monograph orders: 1) Proposed order OTC000038 proposes to make it easier to make (minor) changes to solid oral dosage forms not currently permitted under the specific order, and 2) proposed order OTC000037 proposes to require that certain oral dosage forms, namely orally disintegrating tablets (“ODTs”) and film dosage forms, be packaged in single unit or unit dose containers.

FDA’s proposed order OTC000038, “Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs,” when finalized, will permit manufacturers to make minor changes in the dosage form of certain over-the-counter (“OTC”) monograph drugs, from tablets and capsules to chewable tablets, ODTs, and films, without requesting a separate order, i.e., companies making such dosage form changes need not submit a request for amendment of the applicable OTC monograph order. (To be clear, the minor changes are permitted only for OTC monograph drug products that are included in deemed final orders, and not for OTC monograph products that may remain on the market pending FDA monograph orders allowing or prohibiting such products.)  The proposed order is intended to significantly simplify the development of new dosage forms for oral monograph order drugs that, at this time, may be marketed only in tablets or capsules.

A “requestor” (defined in proposed order OTC000038 as “[a]ny person or group of persons marketing, manufacturing, processing, or developing a drug”) of an OTC monograph order drug making changes to dosage forms subject to the order may manufacture and market that new dosage form, provided the requestor maintains information necessary to demonstrate that the change 1) will not affect the safety or effectiveness of the drug, and 2) will not materially affect the extent of absorption or other exposure to the active ingredient(s) in comparison to a suitable reference product. The suitable reference product must be a capsule or tablet that is swallowed. FDA issued a companion draft guidance, which provides recommended procedures for companies to meet these requirements.

Although this order would provide more flexibility, it does come with a price as, in a companion order, FDA proposes to require that the packaging of drugs in ODT and film dosage form must be consistent with the requirements described in monograph proposed order OTC000037, “Over-the-Counter Monograph Condition B001: Single-Unit or Unit-Dose Containers for Over-the-Counter Monograph Drugs in Orally Disintegrating Tablet and Film Dosage Forms.”  That proposed order, if finalized as proposed, will require that OTC monograph drugs in an ODT or film dosage form and subject to OTC monograph orders be packaged in single-unit or unit-dose containers.

FDA notes that it has, in the past, required single-unit or unit-dose containers for approved new drugs in ODT and film dosage form due to concerns about such products being more palatable than capsules or tablets. Moreover, they are designed to develop rapidly and, for products in film dosage form, there is a concern of films sticking together.  FDA asserts that the single-unit or unit-dose containers help ensure safe and effective use of OTC monograph order drugs in ODT and film dosage forms.

The requirement for the single-unit or unit-dose containers is not a substitute for special packaging, i.e., child resistant packaging required for certain products under the Poison Prevention Packaging Act and implementing regulations.  See 16 C.F.R. part 1700.  The proposed order describes the scope of the order to apply to all orally administered monograph order drug products in ODTs and film dosage form, even those that currently already may be marketed in such dosage form.  As readers of this blog may know, the requirement for child resistant packaging applies only to OTC oral drug products containing certain specific active ingredients.

Comments to proposed order OTC0000037 must be submitted by August 4, 2025, and comments to proposed order OTC0000038 and the accompanying draft guidance must be submitted by October 3, 2025.