An imminent U.S. Food and Drug Administration final rule on cut drug labels is apt to draw blood from pharmaceutical packagers. The final rule, now going through internal review on its way up the Clinton administration chain of approval, will fall far short of what the Nonprescription Drug Manufacturers Association (NDMA) has been pleading for. Unless the FDA's staff gets shot down by political types in the administration, drug companies will have to substitute expensive machine vision systems for the eyesight-based color verification systems now widely used to insure correct labels on shelf packs and unit package cartons. The other verification option will be to set up a separate packaging line for every iteration of every product. "I hope this final rule gets lost," says John Addison, vice president of quality control and technical services for Schering-Plough HealthCare Products. "We'd like to keep things the way they are now." Here is the quick background. In 1993, the FDA issued a final rule on good manufacturing practices for drugs. One provision established three verification methods that a drug company could use to insure that the correct label got on the correct drug package. Then two citizen petitions were filed in the wake of the rule requesting the FDA to consider other controls. FDA then stayed the compliance date for some "cut labeling" controls. These included labels on shippers (also referred to as shelf packs) and unit package cartons, where the cut label is actually the copy on the carton. That stay did not include cut labels put on the immediate product container. They have been subject to the verification procedures since 1993.
FDA rule on cut labels for drugs could draw blood
Agency may require automated verification of labels for both unit packages and shelf packs. Visual verification by color will be eliminated.
Oct 31, 1996
Companies in this article
Machinery Basics
New ebook focused on cartoning equipment
Read about the various types of cartoning equipment, how to select the right one, and common pitfalls to avoid. Plus, read equipment advice from CPGs for ultimate cartoning success.
Read MoreHow Can You Honor a Leader?
Induction into the Packaging & Processing Hall of Fame is the highest honor in our industry. Submit your leader to be considered for the Class of 2024 now through June 10th. New members will be inducted at PACK EXPO International in Chicago
Read More