Drug label is a printed information which is included with any OTC drugs, prescription drugs or any dietary supplements. Drugs labels are regulated by FDA and provide information to healthcare providers and patients on safe and effective use of the product. The information on the labels must be accurate and should not be misleading
All drugs or drug products in finished package form is considered as misbranded if it does not comply with FDA labeling requirements. The labels needs to have the name and place of business of the manufacturer, packer or distributor.
All registered drug establishments which includes API manufacturer, bulk manufacturer, contract manufacturer, repackers, relabelers are required to list their products under their own labeler code, however NDC number is not required to appear on all drug labels, including the label of any prescription drugs given to a customer.
Drugs labels should contain all drug facts which includes active ingredients, purpose and uses of the drug, directions, other information, inactive ingredients, phone numbers if there is any questions or comments.
When there is an expiration date on the drug products, it should appear on the container and also in outer package. However, if it is a single dose drug product packed in individual cartons, the expiry date should be on the individual carton not on the product container.
Manufacturers, Contract manufacturers, repackers, relabelers, and private label distributors of a human prescription drugs or an over-the-counter (OTC) drugs that is regulated under the FD&C act are not required to have bar code on the products. However, if the same drug product that are sold or used in the hospitals are required to put bar code on their products.
Liberty Management Group provides assistance with drug establishment registration, drug listing and label review.
Sudha S
Regulatory Consultant
Email : office@libertymanagement.us