The Food and Drug Administration (FDA) has released draft guidance and a proposed administrative order regarding the documentation required for minor dosage form changes in over-the-counter (OTC) monograph drugs that are highly soluble and highly permeable. Additionally, the FDA has issued a second administrative order mandating that certain OTC monograph drugs be packaged in single-dose or unit-dose containers.
The initial administrative order and guidance focus on transitioning from a tablet or capsule to alternative forms such as chewable tablets, orally disintegrating tablets, or films. This order permits these changes without the need for companies to submit an OTC monograph request. The aim is to simplify the process for companies to develop new dosage forms for their products, reducing the wait time for FDA monograph orders…
