The FDA's release last week of draft guidance on the use of physical-chemical identifiers--inks, pigments, flavors, and other PCIDs--as anticounterfeiting measures in solid oral dosage forms includes such design aspects as pharmacological and toxicological considerations. The agency now seeks comments on the 11-page document, Draft Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting.
To minimize adverse effects, the draft guidance suggests using the lowest level of PCID that can provide product identification. It also recommends that the substance have no medicinal effect, and be incorporated within the dosage form in such a way that that it does not interact with the drug's active ingredient. The FDA also recommends that the PCID be pharmacologically inactive so its ingredients can be treated as excipients.
Radio-frequency identification as an anticounterfeiting measure is not included in the document,
The FDA's timing couldn't be better: A recent UPS supply chain survey found that more than one-third of pharmaceutical and biotech respondents say they are "highly concerned" about product tampering or counterfeiting. "It's rising in importance," says Bill Hook, UPS VP for healthcare logistics global strategy, as reported earlier.
- here's the FDA draft guidance announcement
- see our UPS survey coverage