Physical Chemical Identifiers Play a Role in New FDA Anticounterfeiting Draft Guidance

The US Food and Drug Administration issued a draft guidance for industry, Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting, on July 13. The draft guidance focuses on the use of inks, pigments, flavors, and other physical-chemical identifiers (PCIDs) to make drug products more difficult to duplicate by counterfeiters, and to make it easier to identify the genuine version of the drug, according to an FDA release.

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

According to the press release, PCID is defined 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 flavors, specific chemicals may be used as molecular tags in a PCID.”

The draft guidance recommends that drug manufacturers use the lowest level of PCID possible and to ensure that the PCID used has no medicinal effect. The PCID should be placed within the dosage form to avoid interaction with the drug’s active ingredient, according to the press release.

PCIDs can be easily detected in most cases by wholesalers or pharmacists to determine a product’s authenticity, but occasionally, analytical instruments are necessary to identify a PCID within a product. FDA believes that many potential PCIDs are already in use as food additives, colorants, or other types of inactive ingredients with established safety profiles, according to the release.

Comments on the draft guidance can be submitted electronically to FDA.