The previous 1982-vintage rule had no capsule-sealing requirement but made it necessary for companies to use at least two "tamper-resistant" packaging features. The change to the "tamper-evident" terminology--which will have to be used on packages by November 6, 2000--reflects the FDA's belief that it makes sense to make consumers more wary about OTC product packaging. "Because all packaging is penetrable, and no packaging or dosage form is tamper-proof, consumers should be vigilant when buying and using OTC drug products," the agency said. Most capsule products sold today are sealed anyway. So the effect of the FDA rule is to focus manufacturers' attention on packaging. The FDA resisted some pressure to establish specific "performance" packaging criteria. It opted instead to give manufacturers leeway to adopt any tamper-evident feature(s) that "provides visible evidence to consumers that tampering has occurred..." In essence, though, manufacturers will use the same packaging they are using today. The key change is the requirement for printing of "tamper-evident" on the label by November 6, 2000. Bill Bradley, director of technical affairs for the Non-Prescription Drug Manufacturers Assn. (NDMA), says there are some uncertainties in terms of the best time to make that terminology change. Products that have a front and back label, and plan to put "tamper-evident" on the front, could go ahead and do that at the next scheduled label change. But companies with only one label should wait. That is because the FDA will soon publish a final rule on OTC label "format and content." It will require major changes on all OTC drug labels. Companies with products having only one label will want to wait to see what the "content and format" rule dictates before changing labels to add "tamper-evident."(SB)
FDA 'tampers' with gel capsule labels
The Food & Drug Administration capped its regulatory efforts to make two-piece gelatin OTC capsules harder to tamper with by requiring manufacturers to seal capsules and to use at least one "tamper-evident" packaging feature.
Jan 31, 1999
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