FDA issues draft rules on drug identifiers

The FDA said its draft guidance involves the use of inks, pigments, flavors and other physical-chemical identifiers by pharmaceutical manufacturers to make drug products more difficult to duplicate and to make it easier to identify the genuine version of the drug.

"Drug counterfeiting is a serious public health concern," said Dr. Margaret Hamburg, FDA commissioner. "We look forward to working with industry to help ensure that consumers are not exposed to products containing unknown, ineffective, or harmful ingredients."

The document is intended to provide guidance to industry regarding the use of identifiers in solid oral dosage forms, which include pills and capsules, for anti-counterfeiting purposes.

To minimize adverse effects, the draft guidance recommends using the lowest level of an identifier that ensures identification of the product. It also recommends the substances have no medicinal effect.

The draft guidance is available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati....

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