Comment on FR Doc # 2026-10379

The proposed rule relies on the FDA's National Drug Code Directory and the U.S. NIH DailyMed database to identify products that are no longer marketed and therefore proposed for removal from the DEA Exempted Prescription Products list. Under 21 CFR § 207.41(c)(2), each FDA registrant must list each drug product it manufactures, repacks, or relabels using an NDC that includes the registrant’s own labeler code, regardless of whether the drug is commercially distributed under the registrant’s own label or trade name. Additionally, these listings must be certified annually in accordance with 21 CFR § 207.57(b), and any uncertified listings are subject to removal from the NDC directory. So, a drug product manufactured by a contract manufacturing organization (CMO) and labeled for a private label distributor (PLD) will have two NDCs assigned and active with the FDA: one for the CMO and one for the PLD. However, these NDCs do not appear in the publicly available NDC directory or in DailyMed, even though they are required to be listed and represent marketed drug products. Therefore, I propose that all drug products with currently certified NDC numbers, not just those that appear in DailyMed or the FDA’s publicly available National Drug Code directory, remain on the DEA Exempted Prescription Products list until such time as they are discontinued by the manufacturer or removed by FDA.   The proposed rule relies on the FDA National Drug Code (NDC) Directory and the NIH DailyMed database to identify products that are no longer marketed and therefore proposed for removal from the DEA Exempted Prescription Products list. Based on the proposed list of products to be removed from the Exempted Prescription Products List, it appears that these resources may not provide a complete representation of all currently marketed drug products. Under 21 CFR 207.41, FDA registrants are required to submit and maintain drug listing information for drug products they manufacture, repack, relabel, or distribute. In addition, under 21 CFR 207.57(b), registrants must annually certify that their drug listing information is current. Listings that are not certified may be removed from FDA's public NDC Directory. In many contract manufacturing arrangements, multiple FDA drug listing records may exist for the same marketed product, including records maintained by both the contract manufacturing organization (CMO) and the private label distributor (PLD)1,2. Some active FDA drug listing records may not appear in publicly available databases such as the FDA NDC Directory or DailyMed, even though the underlying product remains actively marketed, listed, and certified with the FDA. Accordingly, absence from DailyMed or the publicly available NDC Directory should not be considered sufficient evidence that a product is no longer marketed. Because DEA's proposed methodology may not identify all currently marketed exempted prescription products, products associated with currently active and annually certified FDA drug listings should remain on the DEA Exempted Prescription Products list unless and until FDA indicates that the product has been discontinued or the listing has otherwise become inactive. DEA should therefore consider utilizing FDA's complete drug listing information, rather than relying solely on publicly available databases, before determining that a product should be removed from the Exempted Prescription Products list. 1 CDER Direct Drug Listing presentation (https://www.fda.gov/media/173707/download) 2 CDER Direct Drug Listing 101 presentation (https://www.fda.gov/media/154498/download)