FDA publishes guidance on anti-counterfeiting markers

Companies developing marker compounds for use in identifying genuine pharmaceuticals often face uncertainty in establishing how to secure regulatory approval for their use.

A new guidance document from the US Food and Drug Administration (FDA) is trying to lend some assistance by providing some pointers on the use of compounds such as inks, pigments, flavours, and other physical-chemical identifiers (PCIDs) into solid oral dosage forms.

The FDA describes a PCID as a substance or combination of substances possessing a unique physical or chemical property used to identify and authenticate a drug product or dosage.

In addition to inks, pigments, and flavours, specific chemicals may be used as molecular tags in a PCID, the agency says.  In some cases, the PCID may be easily detected by wholesalers or pharmacists to determine if they have authentic products.  In other cases, special analytical instruments may be necessary to identify whether the PCID is present.

“FDA anticipates that many of the ingredients that will ultimately be employed as PCIDs are already used as food additives, colourants, or excipients with established safety profiles,” says the guidance.

In the document - available here - the FDA outlines several aspects of an acceptable PCID. A candidate could be used in pills and capsules, and also incorporated into packaging and containers, said the agency.

The lowest possible level of the compound allowing identification of a genuine product should be used, and the substance should be pharmaceutically inactive and relatively inert - so that it qualifies as an excipient.

The PCID should be placed in a portion of the dosage form away from the active ingredient so as to avoid degradation, and should be separated from any excipients which affect the release profile of the active ingredient.

“Drug counterfeiting is a serious public health concern,” commented FDA Commissioner Peggy Hamburg. “We look forward to working with industry to help ensure that consumers are not exposed to products containing unknown, ineffective, or harmful ingredients.”

The guidance is up for comment until October 13, and provides recommendations to pharmaceutical manufacturers on the supporting documentation to be submitted in applications for new drugs or for changes to existing products.

It also gives recommendations on the toxicological evaluations that may be needed for PCIDs that are incorporated into packaging and labelling as well as procedures for reporting or requesting approval to add PCIDs to packaging and containers as a post-approval change.