💊FDA Proposes New Order for OTC Drug Dosage Form Changes
Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs
Summary
The Food and Drug Administration (FDA) is announcing the availability on its website of the proposed administrative order (proposed order) (OTC000038) entitled "Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs." This proposed order, if finalized, will permit minor dosage form changes, i.e., from tablets or capsules to chewable tablets, orally disintegrating tablets, or films, of over-the-counter (OTC) monograph drugs that are in conformity with the requirements of the order, the Federal Food, Drug, and Cosmetic Act (FD&C Act), and other applicable requirements, without the issuance of a separate order amending an applicable OTC monograph to add the new dosage form or otherwise finding the new dosage form to be generally recognized as safe and effective (GRASE).
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The proposed order allows OTC drug manufacturers to change solid oral dosage forms without a separate order, streamlining the process and reducing regulatory barriers. This enhances flexibility for businesses in the pharmaceutical sector and could lead to cost savings and quicker market access for new forms.