Note: This is an edited version for posting on the Internet of the Compliance Policy Guide (CPG) contained in the 1996 print edition of the Compliance Policy Guides Manual (manual). The edited version is in August 2000 print edition of the manual. This CPG is intended for FDA personnel and also may be used by industry. The CPG does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.
BACKGROUND AND POLICY:
It has come to our attention that not all manufacturers indicate on the container labels whether or not the allergenic extract contains glycerin. Since preparations containing glycerin cannot be injected without discomfort, many allergists do not inject such extracts. Therefore, as an added item of important information, manufacturers who prepare glycerinated allergenic extracts, must indicate on the container label, the presence of any amount of glycerin in the final product.
Secondly, in accordance with "Changes To Be Reported - 21 CFR 601.12", we wish to emphasize that the *Center for Biologics Evaluation and Research* must be notified regarding any changes in labeling and manufacturing methods *for any licensed biologocal. Such changes include the addition of* any new allergenic extract to *a licensed* manufacturer's listing of approved extracts. If the changes require a prior approval supplement, a manufacturer may not distributed product made using the change until the manufacturer receives notification from CBER [i.e., approval of a supplement to the biologics license application] that the change is approved.
Revised: 10/1/80, 4/1/82, 3/95, edited 08/2000