Checklist for Generic Pharmaceutical prescription drug Labeling in Regulatory Affairs for US Market

Verify the compliance of the label with the Federal Food, Drug, and Cosmetic Act (FDCA).

Ensure the label includes the proper drug name (both proprietary and established names).

Confirm that the strength of the drug is clearly indicated.

Check that the dosage form is accurately described.

Ensure the label includes the NDC (National Drug Code) number.

Verify the inclusion of a statement of identity.

Confirm the indication or use of the drug is clearly stated.

Ensure that the dosage and administration instructions are provided.

Check for specific storage conditions and handling instructions.

Confirm the inclusion of a warning statement if applicable.

Ensure that the inactive ingredients are listed.

Verify that the labeling includes information on the manufacturer or distributor.

Check for the expiration date and any specific stability information.

Confirm that any required patient information leaflets (PILs) are included.

Ensure that the labeling complies with any REMS (Risk Evaluation and Mitigation Strategy) requirements.

Ensure that the font size meets FDA guidelines for readability.

Confirm that the layout and design comply with FDA regulations.

Check that colors and graphics do not mislead or confuse consumers.

Ensure that all information is presented in a clear and concise manner.

Verify that the label is free from typographical errors and inconsistencies.

Confirm that the labeling is included in the ANDA (Abbreviated New Drug Application) submission.

Ensure that any changes to the labeling are documented and submitted as required.

Verify compliance with post-marketing reporting requirements.

Check for any additional state-specific labeling requirements that may apply.

Ensure that labeling is updated in accordance with any new safety information or FDA guidance.

Conduct a final review of the labeling by regulatory affairs personnel.

Ensure that all labeling changes are communicated to relevant stakeholders.

Confirm that the final label is approved by the appropriate regulatory body.

Check that the labeling is printed and distributed according to the approved specifications.

Maintain records of the labeling version history and approvals for regulatory compliance.