FDA takes Steps to Fight Counterfeit Drugs
The U.S. Food and Drug Administration seeks to make it more difficult to pass off counterfeit drugs through the use of inks, pigments, flavors, and other physical-chemical identifiers (PCIDs).
A PCID is a substance or combination of substances possessing a unique physical or chemical property used to identify a drug. In some cases, the PCID may be easily detected to determine if they have authentic products. In other cases, special analytical instruments may be necessary to identify whether the PCID is present.
Many of the potential PCID ingredients are already commonly used as food additives, colorants, or other types of inactive ingredients that are known to be safe.
To further minimize adverse effects, the FDA recommends using the lowest level of PCID that ensures identification of the product. The PCID should be a substance with no medicinal effect and placed within the dosage form so that it does not interact with the drug’s active ingredient.
The FDA invites comments on the draft guidance, available online and titled “Draft Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting.”
For more information please see: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm171632.htm