Review by CDER

When the submission is received in the Division of OTC Drug Products, a project manager conducts an initial review to determine the type of drug being referenced and then forwards the submission to the appropriate team for a more detailed review. The team leader determines if the submission will need to be reviewed by other discipline areas in the review divisions, such as chemists or statisticians, or by other consultants, such as those from other centers or agency offices. The submission is then forwarded to a team member for review.

If the submission is a comment or opinion on a specific rule or OTC drug monograph, there is no deadline established for CDER to respond. However, if the submission is a petition or request to amend a monograph, or request to have a drug approved based on an existing monograph, the OTC division has 180 days to review the data and respond to the submitter.

When the submission is reviewed, the drug is categorized through the monograph rulemaking process as follows:

• Category I - generally recognized as safe and effective and not misbranded.
• Category II - not generally recognized as safe and effective or is misbranded.
• Category III - insufficient data available to permit classification. This category allows a manufacturer an opportunity to show that the ingredients in a product are safe and effective, or, if they are not, to reformulate or appropriately relabel the product.

CDER also oversees OTC drug labeling because the safety and effectiveness of OTC drug products depend not only on the ingredients but also on clear and truthful labeling that can be understood by consumers.

When the initial review is complete and other consult requests have been received, a "Feedback Letter" outlining CDER's recommendations may be prepared for the submitter. The recommendations will vary depending on the type of data submitted. For example, a response based on a request to amend a monograph may contain explanations approving or disapproving the amendment.

If the submitter is not satisfied with the recommendations made by the division, the submitter may request a meeting to discuss any concerns.