FDA APPROVES NEW SPARKLE FOR Rx DRUGS

Pharmacy Times, Volume 0, 0

The FDA has approved new pharmaceutical pigmentation rules that arelikely to give extra sparkle to the pills and tablets dispensed by Americanpharmacists. Under the new regulations, manufacturers will be allowed touse "pearlescent pigments" in virtually all oral human drugs, includingtablets, pills, and liquids. Similar to the coloring agents used in many cosmetics,the new pigments can produce metallic or satiny finishes on drugsand can even be used to provide extra coloring.

The pigments are made by coating the mineral mica with either titaniumdioxide or iron oxide—substances used to add luster to everything fromlipstick to automobile paint. Under the new rules, the pigments cannotmake up more than 3% of the weight of a drug.

According to the FDA, "there is no toxic potential when [pigments are]ingested at levels estimated by the agency."