Type of Posting: Notice of Intent to Revise
Posting Date: 16-Apr-2021
Targeted Official Date: 01-May-2021; Revision Bulletin
Expert Committee: Small Molecules 5
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 5 Expert Committee intends to publish a Revision Bulletin to provide an additional 30-months implementation time for the Albuterol Inhalation Solution monograph. The official date of the monograph will change from May 1, 2021 to November 1, 2023.
Comments were received that the marketed albuterol inhalation solution products are using the name “Albuterol Sulfate Inhalation Solution,” and an extended implementation time may be required for the marketed product nomenclature to be revised. The approved title "Albuterol Inhalation Solution" is consistent with <1121> Nomenclature and with the Monograph Naming Policy for Salt Drug Substances in Drug Products. The additional 30-months implementation time, as described in <1121> Nomenclature, is provided to facilitate adoption of the monograph and changing the name of the marketed products to “Albuterol Inhalation Solution.”
Should you have any questions, please contact Shankari Shivaprasad, Principal Staff Scientist (firstname.lastname@example.org).