Sealed Two-Piece Capsules Mandatory

Only one tamper-evident packaging feature now required.

FDA now requires drug manufacturers to seal over-the-counter (OTC) two-piece hard-gelatin capsules using a tamper-evident technology. The move, which is designed to combat product tampering, could lead to slightly less packaging on some products.

The final rule, published in the Federal Register on November 4 (63FR 59463—59471), not only mandates two-piece capsule sealing but also requires that manufacturers use the term tamper evident instead of tamper resistant to describe any safety packaging. Labeling with the term tamper resistant will now have to be changed. The sealing requirement is effective November 4, 1999, while labeling changes must occur by November 6, 2000.

Drug tampering regulations have existed since seven people died in 1982 after taking cyanide-laced Extra-Strength Tylenol. The poisonings prompted the first tamper-resistant mandate, which was amended in 1989 after tampering problems continued with two-piece hard-gelatin capsules. That amendment, in force until now, required either two tamper-resistant packaging features on unsealed two-piece capsules, or one such packaging feature on sealed ones.

With the new rule, FDA takes that option away and instead requires all such capsules to be sealed, and then packaged with at least one tamper-evident feature. The impetus for the rule was two more deaths in 1991 from cyanide-laced Sudafed capsules. The proposed rule was published January 18, 1994.

"Sealing makes it virtually impossible for a tamperer to disturb the integrity of the product and recombine the two parts of the capsule without leaving conspicuous signs of entry," the agency wrote. "Protective features (in packaging) could be removed by the tamperer without leaving any signs of tampering to consumers unaware of the packaging normally used."

One comment from industry submitted in response to the proposal suggested that manufacturers would still feel compelled to use two packaging features in addition to the sealing, because consumers might think something is wrong if one of the packaging features they are used to seeing is missing. FDA said that informative labeling and retailer counseling should alleviate consumer concerns about packaging changes.

OTC dermatologic, dentrifice, insulin, and lozenge products are exempt. FDA considers these products to be less of a tampering risk.

The rule's effect on industry won't be too far-reaching, however, because FDA could only identify 22 OTC drugs that are still sold in unsealed two-piece capsules. Unsealed capsules are much more common for nutritional supplements, which are not subject to the regulation.

Matt Croson, director of communications for the Packaging Machinery Manufacturers Institute (PMMI; Arlington, VA), said he does not see a significant impact. "There may be a small rise in companies that have to purchase a heat sealer or something like that. I don't think you'll see too many going the other way and using less packaging."

FDA considered requiring tamper-evident packaging features to meet specific performance standards, but decided against it, preferring to "set forth the general standard of tamper evidence and to remain flexible with respect to alternative technologies."

The new rule clarifies the requirement for listing tamper-evident features in labeling, which must all be identified. Some manufacturers had originally thought the proposed rule applied only to the features on the outside of the package.

The replacement of the term tamper resistant with tamper evident is necessary, says FDA, because the former implies that a product can be immune to tampering, which is never the case. Tamper resistant can therefore imply a sense of security, while tamper evident better describes the actual role of the safety packaging, which is to provide evidence that a product or its package has been tampered with.

The agency will launch a consumer-education campaign to raise awareness of the issue. It seeks assistance from industry, trade associations, consumer groups, and other government agencies.

FDA estimates the cost of labeling changes at $10 million and the cost of the sealing mandate at $5.5 million–$250,000 for each of the new capsule-sealing and -banding machines that will have to be purchased for the 22 OTC products still sold in unsealed capsules.

For more information, contact Thomas C. Kurchenberg, Center for Drug Evaluation and Research, FDA, 301/ 594-5640.

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