FDA releases new colour additive regulation
FDA has lifted a stay on a final rule that amended the colour additive regulations to provide for the safe use of mica-based pearlescent pigments as colour additives in ingested drugs.
FDA has lifted a stay on a final rule that amended the colour additive regulations to provide for the safe use of mica-based pearlescent pigments as colour additives in ingested drugs.
The Agency received two objections to this rule when it was initially published in July 2005, and put a stay on it until the objections could be reviewed - the Agency denied the objections, and this final rule is effective as of July 20, 2006.
The pearlescent pigments can be used in any drugs that are swallowed, including pills, tablets and liquids. They can produce sparkly metallic, satiny and shimmery finishes in addition to different reds and golds.
The pigment technology is important, FDA says, because it can give drugs a unique look that is hard to copy, and it can be used to thwart counterfeiting as well as aid in reducing dispensing and patient medication errors.
To underscore the importance of clear medication identification, the pharmacy boards of California, Wyoming and Oregon have instituted regulations that require prescription medication container labels to include the colour, shape and any identification code appearing on the tablets or capsules.