Confusion is abundant when it comes to understanding what the U.S. Food and Drug Administration expects from the drug industry in the way of label verification. "There is probably a lot of confusion," admits Paul Motise, a top FDA compliance official. He should know. As the lead federal official for the long-running and confusing rulemaking on cut labels for pharmaceuticals, he has, probably unknowingly, created the miasma. "This rule has been bounced around right and left. It's a mess. But we'll get it right." And it is not just the agency who is confused. Dan Gerner, president of Packaging Coordinators, Inc. (Philadelphia, PA), which does contract packaging for pharmaceutical companies and others, admits his customers are often unsure of FDA requirements. He is equally as foggy, which is scary, since his company has nine plants and 100 packaging lines around the country. He believed that the FDA requires automated label verification for the folding carton that holds a container. Wrong! The rule in question The rule Motise refers to is the one that was published in August 1993. Only one of its provisions ever went into effect, and that was in August 1994. It said cut labels on the immediate product container must be electronically verified. Neither the product carton nor the shelf pack is an immediate container, nor is an insert a label. Those items are not covered yet, but will be the subject of an upcoming proposed rule scheduled for the first quarter of 1997. Products with labels from rolls are not covered, and never will be. So if a cut label is put on an aspirin bottle, wrapped around a toothpaste tube, affixed to the back of a blister pack, or stuck on a jar of prescription pills, that label has to be verified by a code reader or vision system. The only exceptions are when the cut label is on an immediate container for a low-volume product, for example, your all-purpose teat dip for cows. And if you are restricting use of the assembly line to one size and dose of a product, no automated verification is needed for that product label. Gerry Frank, chairman of the Drug and Pharmaceutical Packaging Committee for the Institute of Packaging Professionals (IoPP), and director of packaging technology and labeling at RhYne-Poulenc Rorer, Collegeville, PA, says many of the big OTC and ethical drug companies have taken the position that they will verify all printed material on their assembly lines. And they require label suppliers to verify as well. RPR has about 15 lines. The basic verification system the company uses is one put together by Systec Solutions (Cranbury, NJ), a systems integrator. But equipment isn't uniform. Waiting for now Many of the small drug manufacturers are probably waiting to see what the FDA says in early 1997 before spending tens of thousands of dollars on label verification equipment. This latest chapter in this rulemaking-actually it will be a proposed rule with request for comments-will be divided into three parts. First, the FDA will say inserts do not have to be verified at all, ever. Second, it will add another verification option to bar-code readers and vision systems: automated color verification. Third, verification for product cartons, shelf packs and other packaging will, at long last, go into effect in August 1997. While drug companies are likely to welcome the ability to use automated color verification systems, they may have some of the same questions about those as they do about bar-code and vision systems. Chief among those questions is which equipment meets FDA requirements? Paul Motise says the FDA will not provide a list of which vendors pass muster. "We are not going to pick winners and losers," he explains. "Packagers can use any automated system that performs properly and has been validated. It is the packager's responsibility to make sure the validation is done right." Trampled by technology Tom Kuchenberg, another FDA official, explains that the FDA is also concerned that if it sanctioned certain technologies, they would quickly become outdated. "Where are those Wang computers?" he asks. "And if we did specify technologies, we would either be accused of being too vague or micromanaging industry." In fact, the Nonprescription Drug Manufacturers Assn. (NDMA) told the FDA in November 1994 that: "The FDA should not freeze these specific technologies into the CGMP regulations to the exclusion of other effective labeling systems or procedures." So the message to drug packagers is "you're on your own, baby." Wouldn't it at least make sense, at a minimum, for the FDA to provide a list of problems it has turned up in inspections of drug companies? Motise says no such list is available. That may be because the FDA has done little or nothing to integrate label verification inspection into its broader Good Manufacturing Practice inspections. Motise says he does not know how many such inspections have been done since August 1994. IoPP's Frank says he has asked for a show of hands at IoPP meetings of anyone whose label verification system has been inspected by the FDA. No hand has ever been raised. Who to advise? Motise says it is up to the trade associations to advise their members. IOPP's Frank says that the committee has not given advice to IoPP members on this issue. FDA requirements, that is to the best anyone can figure them out, have been discussed at four drug committee meetings. "It has never been the IoPP's position that we should tell members how to do something," he explains. So there is this new frontier called drug label verification, and it is a bit lawless, like the Old West, with vendors riding into town every day. John Brogan, president of Brogan Printing and Packaging (Alpha, NJ), and chairman of IoPP's adhesives committee, says drug packagers have been "bombarded" by all kinds of "kamikaze schemes." There are some well-respected bar-code reader manufacturers in the marketplace, like Datalogic (Scotts Valley, CA). Its equipment can be souped up to do a lot more than is required by the FDA's drug label verification rule. The base price for its top-of-the-line system is $11괾, plus $1군 to $1귔 per scanner. Do companies have to spend even that much? RhYne-Poulenc Rorer's Frank notes that the cost of a base bar-code reader is only $1군. "What costs more is the infrastructure you put around it," he says. The RPR system, which Frank declines to identify (or allow to be photographed), uses both bar-code readers and machine vision. It's safe to assume each system costs more than $1군, although Frank isn't saying how costly they are. Affecting development? Not only does confusion over FDA requirements chill the purchase of label verification equipment by drug packagers, but vendors may be hesitant to introduce new products. For example, Key Technology, Inc. (Walla Walla, WA) has a new pharmaceutical inspection system for monitoring colors of capsules, gelcaps and other products. Could this system be adapted by Key so that it can be used for automated color verification if and when the FDA gives it the green light? Richard Hebel, vice president of corporate marketing and business development at Key, answers with a definite "maybe." "Whether our system will suffice for the diligence in label inspection required by the FDA remains to be seen," he states. Drug packagers are even shy about using existing technology that might be considered "out there." Take two-dimensional data matrix bar codes. Has anyone seen them on a drug label? "Few people are taking the risks and trying them," says Brian King of Datalogic. Part of the reason, of course, is that most bar-code readers cannot read data matrix bar codes. Datalogic is working with RVSI (Hauppauge, NY) to develop an upgraded reader. It will use ID Matrix's (Canton, MA) new fast decoder as part of its vision systems. The beta machine will be tested in Bayer's pharmaceutical plant in Meyerstown, PA. That is scheduled for first quarter 1997. "There has been talk about data matrix for 10 years," explains King. "But in the real world, there are always a lot of worries when you go with something new. No one ever got fired for using Allen-Bradley."
