Revision Bulletin: Postponement

Enoxaparin Sodium and Enoxaparin Sodium Injection

Revised Posting Date:	April 29, 2009
Original Posting Date:	November 26, 2008
Official Date:	December 1, 2009
Expert Committee:	Biologics Biotechnology-Blood and Blood Products
Transfers to History Section:	December 31, 2009

In accordance with the Rules and Procedures of the 2005-2010 Council of Experts, section 9.08(c)*, USP is extending the postponement for the Enoxaparin Sodium and Enoxaparin Sodium Injection Monographs to 1 December 2009, effective immediately. Both monographs are postponed until the method in General Chapter <207> Test for 1,6-Anhydro Derivative for Enoxaparin Sodium becomes official in the Second Supplement USP 32–NF 27 (1 December 2009). The original postponement for the Enoxaparin Sodium and Enoxaparin Sodium Injection Monographs was posted 26 November 2008 due the unavailability of Reference Standards associated with these monographs. All Reference Standards are expected to be available when the two Enoxaparin monographs become official in December 2009.

While General Chapter <207> will provide the official test for 1,6-Anhydro Derivative, manufacturers are always permitted to use alternative tests in accordance with Section 6.30 of USP General Notices in USP 32-NF 27, "Alternative and Harmonized Methods and Procedures" (196KB). Manufacturers with differing approved specifications, or those who are pending FDA approval should submit their specifications to USP for consideration as possible flexible or Pending Monographs. Additional information regarding USP's flexible monograph approach can be found in the Guideline for Submitting Requests for Revision on USP's Web site. For further information on USP's Pending Monograph program, see the Pending Monograph Guideline on the USP Web site. Any questions should be directed to Anita Szajek, Ph.D. (301-816-8325 or ).

Download Postponed Enoxaparin Sodium Monograph (66KB)
Download Postponed Enoxaparin Sodium Injection Monograph (102KB)
Download General Chapter <207> Test for 1,6-Anhydro Derivative for Enoxaparin Sodium (163KB)

*9.08(c) Granting of postponement. The Expert Committee responsible for approving the standard for which postponement is sought shall have the authority to postpone the official date of any requirement or textual material in such standards; provided, however, that all decisions to postpone shall require review and approval by the CoE Chairperson, who may at his or her option refer the matter to the Executive Committee for its consideration.