This post was written by Paul Sheives. The Food and Drug Administration (FDA) has published a final rule entitled “Revision of the Requirements for Constituent Materials.” The rule allows FDA to approve exceptions or alternatives to the regulation for constituent materials in biologics (i.e., ingredients, preservatives, diluents, adjuvants, extraneous protein, and antibiotics that are contained in a biological product). FDA notes that technical advances have rendered the preceding regulations too prescriptive and restrictive. Accordingly, FDA will entertain requests for approval of alternatives or exceptions when the data submitted in support of such a request establish the safety, purity, and potency of the biological product for the conditions of use, including indication and patient population, for which the applicant is seeking approval.  The rule is effective May 13, 2011.