FDA issues Anticounterfeiting Guidance

The U.S. Food and Drug Administration (FDA) posted on itswebsite a draft document for comment entitled “Guidance for Industry, Incorporation ofPhysical-Chemical Identifiers into Solid Oral Dosage Form Drug Products forAnticounterfeiting.”1 This memorandum summarizes the Guidance.

FDA states in the introduction to the Guidance that it was prompted by actionsbeing taken and/or considered by industry to add inks, pigments, flavors, and other physicalchemicalidentifiers (PCID) to Solid Oral Dosage Form (SODF) drugs (pills, capsules) to make itmore difficult for counterfeiters to duplicate said drugs and make it easier for the public andhealth care professionals to identify the genuine version. The Guidance addresses the design ofthe PCID, the manner in which it is incorporated in the SODF, and the obligation of themanufacturer in so doing to communicate information about the addition to FDA. FDA outlinesseveral aspects of an acceptable PCID. It can be used in pills and capsules, and also incorporatedinto packaging and containers. The lowest level of PCID possible should be utilized to allowidentification and the substance chosen should be pharmaceutically inactive and relatively inertso that it qualifies as an excipient. It should be placed in a portion of the SODF away from theactive ingredient so as to avoid degradation, and should be remote from any release controllingexcipients so that the PCID will not interfere with a release rate designed for the drug.

The Guidance provides input on the actions the manufacturer should take tominimize the toxicological risk of any PCID utilized. The main recommendation FDA makes isfor the manufacturer to use permissible direct food additives, including those affirmed asGenerally Recognized as Safe (GRAS) or those listed in the FDA Inactive Ingredient Guide.2 Ifused in packaging or in a container, the same general considerations apply that apply to theincorporation of food contact substances, such as determining that the PCID will not migrateunacceptably from the packaging to the drug product.

The Guidance concludes with information on reporting changes for pre-marketingand post-approval addition of PCIDs to SODFs, and to containers and packaging. It describesthe several reporting categories that might apply.

FDA has requested that comments on the Guidance be submitted by October 13,2009.