FDA's Anticounterfeiting Guidance Dodges Secrecy Concerns
This article was originally published in The Pink Sheet Daily
In final guidance on the use of physical-chemical identifiers in solid oral dosage form drugs, FDA avoids addressing commenters' qualms about confidentiality.
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FDA has issued a draft guidance that recommends pharmaceutical manufacturers use "pharmacologically inactive" substances as physical-chemical identifiers (PCIDs) in solid oral dosage forms to fight drug counterfeiting. The draft guidance, entitled "Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting," notes that inks, pigments and flavors are some examples of substances that may be incorporated into solid dosage forms. The guidance notes that PCIDs should be "pharmacologically inactive so the ingredients can be treated as excipients." FDA recommends using "permissible direct food additives," including those affirmed as generally recognized as safe or those ingredients listed in the FDA Inactive Ingredient Guide to minimize toxicological risks. Various technologies that can be used to detect PCIDs include photolithography, holography, and laser scanning devices. The guide also addresses reporting or requesting approval to incorporate PCIDs into drug products as a postapproval change. Comments on the draft guidance are due Oct. 13
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