Thursday, July 16, 2009

FDA Issues Guidance on Anti-Counterfeiting Techniques: Physical-Chemical Identifiers for Drugs

The Food and Drug Administration continues in its efforts to regulate and provide guidance on anti-counterfeiting solutions. This press release from July 13, describes their latest efforts on providing guidance on physical-chemical identifiers (PCIDs) which are added to medications by the manufacturers to make drugs more difficult to counterfeit and adulterate.

XStream supports and believes that a variety of solutions and techniques are vital in protecting the pharmaceutical supply chain and healthcare consumer from fraudulent, adulterated and counterfeit medications. PCIDs are one component of a secure pharmaceutical supply chain.

Currently the FDA is seeking comments on this guidance:

The FDA July 13 issued a draft guidance on PCIDs used by manufacturers to make drugs more difficult to counterfeit and to make genuine versions of drugs easier to identify.

The draft “Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anti-Counterfeiting” is intended to provide guidance on the use of PCIDs in pills and capsules.

According to the agency, PCIDs have unique physical or chemical properties used to identify and authenticate a drug product or dosage. The substances include inks, pigments and flavors, as well as various chemicals that can be used as molecular tags to form a PCID. The FDA anticipates that many of the potential ingredients for PCIDs already are used as food additives, colorants or other “inactive ingredients with established safety profiles.”

The draft guidance recommends using the lowest level of PCID possible to ensure identification of the product. The PCID also should be a substance with no medicinal effect and no potential to interact with the drug’s active ingredient, according to the FDA.

Comments on the draft guidance may be submitted electronically at The comments, due by Oct. 12, should be identified with docket number FDA-2009-D-0212.

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