Regulatory Open Forum

1.11 Discontinued Section

Those drug products in the discontinued section of the Orange Book (Discontinued Drug Product List) for which a determination has been made that the products were not withdrawn for safety or effectiveness reasons have been annotated with a footnote following the product strength: "**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**". The determinations listed in the Orange Book are only reflective of determinations made since 1995 and published in the Federal Register. The identification of these drug products in the Discontinued Drug Product List should avoid the submission of multiple citizen petitions requesting a determination for the same drug product.

Generally, approved products are added to the Discontinued Drug Product List when the applicant notifies the Division of Orange Book Publication and Regulatory Assessment (DOBPRA) of the products' not-marketed status. Products may also be added to the Discontinued Drug Product List if annual reports or other submissions to the Agency indicate the product is not being marketed or as a result of other Agency administrative actions.²¹ Changes to the Orange Book are not affected by the drug registration and listing requirements of Section 510 of the FD&C Act.

1.12 Changes to the Orange Book

Every effort is made to ensure the Annual Edition is current and accurate. Applicants are requested to inform DOBPRA of any changes or corrections, including any change in ownership or a product's marketing status that would result in the product being moved to the Discontinued Drug Product List. FDA notes that under Section 506I(a) of the FD&C Act, applicants must notify the Agency in writing 180 days prior to withdrawing a drug product from sale, or if 180 days is not practicable, not later than the date of withdrawal from sale. Furthermore, Section 506I(b) of the FD&C Act requires that applicants notify the Agency in writing within 180 days of approval of a drug product if such drug product will not be available for sale within 180 days of approval. A request to include a newly approved product in the Discontinued Drug Product List, rather than parts 1 or 2 of the Orange Book (as discussed in Section 1.1), must be submitted to DOBPRA by the end of the month in which the product is approved to ensure that the product is not included in the "active" portions of the next published Orange Book update.