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FDA Proposes Requirements for How Requestors Can Make Minor Dosage Form Changes to Certain Over-the-counter Monograph Drugs
Today, the U.S. Food and Drug Administration (FDA) is proposing requirements for how requestors can make minor dosage form changes to certain over-the-counter (OTC) monograph drugs.
FDA issued Proposed Administrative Order OTC000038 that, if finalized, will specify the requirements for minor dosage form changes to certain OTC monograph drugs from tablets and capsules to chewable tablets, orally disintegrating tablets (ODTs), or films. The proposed order is being released with a companion draft guidance for industry, with recommendations on how requestors can comply with the requirements in the proposed order, if finalized.
Some people find it hard to swallow tablets or capsules. This proposed order, if finalized, would allow industry to innovate and introduce chewable tablets, ODTs, and films for certain OTC monograph drugs without submission of an OTC Monograph Order Request and issuance of a related final order amending an applicable OTC monograph to add these new dosage forms. Chewable tablet, ODT, and film dosage forms are user-friendly for people who have difficulty swallowing tablets or capsules.
FDA has also issued Proposed Administration Order OTC000037 to establish requirements for the packaging of certain OTC monograph drugs in ODT or film dosage forms. This order will help promote the safety of OTC monograph drugs in ODT or film dosage forms.
The proposed orders and draft guidance are open for public comments.
Additional information
- For more information on the proposed orders, read the proposed orders on the OTC Monographs @ FDA
- For answers to frequently asked questions about OTC monograph drugs and the administrative order process, visit the OTC Monographs @ FDA
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