§206.10. Code imprint required. — Inbound Citations

(1) For a drug subject to premarket approval, FDA may provide an exemption from the requirements of § 206.10 upon a showing that the product's size, shape, texture, or other physical characteristics make imprinting technologically infeasible or impossible.

(i) Exemption requests for products with approved applications shall be made in writing to the appropriate review division in the Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266 or the Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002. If FDA denies the request, the holder of the approved application will have 1 year after the date of an agency denial to imprint the drug product.

(ii) Exemption requests for products that have not yet received approval shall be made in writing to the appropriate review division in CDER or CBER.