The world of Over-The-Counter (OTC) drug development is changing and fast. In a move that promises to make product updates more agile and consumer-friendly, the U.S. Food and Drug Administration (FDA) has released a draft guidance and proposed administrative order—C001—that creates a clear regulatory path for certain minor dosage-form changes to monograph-compliant OTC drugs. At EMMA International, we’re excited about what this means for the future of OTC product innovation and how we can help our clients seize this opportunity.
For years, OTC manufacturers have faced a frustrating barrier: wanting to modernize their product format (say, turning a standard tablet into a chewable or orally disintegrating tablet), but being stalled by regulatory ambiguity. Even seemingly minor changes required time-consuming and resource-intensive monograph amendments, discouraging innovation that could improve consumer access and experience.
The FDA’s new proposed order changes that. If your product contains an active ingredient classified as both “highly soluble” and “highly permeable,” you may now be eligible to convert it into a chewable tablet, orally disintegrating tablet (ODT), or film without undergoing a full monograph revision. The caveat? You must demonstrate, through data, that the new form does not affect safety, efficacy, or exposure levels.
This is a significant step toward modernizing the OTC landscape. It’s also a nuanced regulatory shift that demands careful planning and robust data. That’s where EMMA International comes in.
Our team is already working with clients to assess product eligibility under this new pathway. We’re designing dissolution studies, crafting permeability justifications, and building comprehensive documentation packages that align with the FDA’s expectations. We understand what the agency is looking for: data that supports equivalency, packaging that protects integrity (particularly for chewables and films), and evidence that consumers will experience the same therapeutic benefit—even in a more convenient form.
Beyond technical support, we’re also advising clients strategically. Should you move now or wait until the guidance is finalized? How will this affect your portfolio planning over the next 12 to 24 months? What other dosage-form innovations might be viable under future guidance?
The timing couldn’t be better. This draft order aligns with the FDA’s OTC Monograph Reform under the CARES Act and its commitments under OMUFA (Over-the-Counter Monograph User Fee Program). It signals a more modern and collaborative approach to regulating consumer health products one that rewards science-backed flexibility.
Public comments on the draft guidance are open through October 3, 2025. We encourage our clients to not only prepare for implementation but also consider submitting feedback especially if you have products or data that could influence the final version.
At EMMA International, we believe regulatory strategy is not just about compliance but it’s about enabling innovation. With C001, the FDA is opening a door. Let us help you walk through it with confidence.
For more information on how EMMA International can assist, visit www.emmainternational.com. Contact EMMA International at (248) 987-4497 or by email at info@emmainternational.com to learn more about how we can support your efforts.
