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Acitretin Capsules: Notice of Intent to Revise

Posting Date: 22 July 2009
Targeted Official Date: 1 February 2010
Expert Committee: Monograph Development–Ophthalmology, Oncology, and Dermatology

In accordance with the Rules and Procedures of the Council of Experts, the Monograph Development–Ophthalmology, Oncology, and Dermatology (MD–OOD) intends to revise the Acitretin Capsules Monograph based on comments received. The revised Assay preparation will indicate that the contents of the capsules are used rather than the entire capsules including the shells. The acitretin concentration of Assay preparation will also be specified.

It is anticipated that the proposed revision will be published in Pharmacopeial Forum 35(5) [Sep.–Oct. 2009] as a Proposed Interim Revision Announcement. In the absence of any adverse comments, the revision will be published as final in Pharmacopeial Forum 36(1) [Jan.–Feb. 2010] with an official date of 1 February 2010.

Should you have questions, please contact Feiwen Mao, M.S. (301–816–8320 or ).