Product Labeling Requirements

Product Labeling Requirements. All product labeling shall comply with the applicable requirements of Title 21 of the Code of Federal Regulations, including Part 201 (drug labeling), Part 801 (medical device labeling), or Part 101 (food labeling), as applicable. Labels shall include all required elements including, but not limited to: product name (proprietary and established), active ingredients and strength (for drugs), intended use or indications, directions for use, warnings, precautions, contraindications, adverse reactions, storage conditions, lot number or batch number, expiration date, and the name and address of the manufacturer, packer, or distributor. All labeling text shall be legible, conspicuous, and in the English language (with additional languages as required by the target market). Labeling changes shall be processed through the formal change control system and, where applicable, shall be submitted to the FDA for approval prior to implementation through a Prior Approval Supplement (PAS) or Changes Being Effected (CBE) supplement. The Manufacturer shall maintain specimen labels for each lot produced and shall retain labeling records as required by 21 CFR Part 211.186.