LABEL CONTROLS SUBJECT OF PROPOSED GMP REGULATION CHANGES

LABEL CONTROLS SUBJECT OF PROPOSED GMP REGULATION CHANGES: the proposed changes would include a provision for the identification of unlabeled containers, Office of Compliance Director Daniel Michels said at a June 9 meeting of the National Association of Pharmaceutical Manufacturers. FDA is in the process of developing the proposal, which will be published in an upcoming Federal Register. For finished drugs that are put into unlabeled containers or "bright stock," FDA suggests that "containers must be adequately identified to assure the correct labeling is ultimately applied to the appropriate containers," Michels said. He added, "the staff is proposing [for] bright packaging situations for unlabeled containers held pending further labeling operations, that those labeling procedures include a provision requiring they be identified with a name, strength, quantity of contents, and a lot or control number." Labeling practices have been a compliance office priority since last October, when compliance office staffer Anthony Lord reported the results of his study on recalls that showed product mislabeling was the most frequent reason for recalls between 1983 and mid-1987. FDA Commissioner Young recently pointed to the problem of recalls caused by label mix-ups in a January letter to the presidents of five pharmaceutical industry associations. FDA is also considering modifying the regulation "to prohibit gang printing of labeling to be used for different products or different strengths of the same product, unless the labeling for the gang printed sheets is adequately differentiated by size, shape, or color," Michels noted. As with bright stock, the use of cut labels is considered one of the higher risk practices, according to Michels. Cut labels could be permitted, he noted, "if labeling and packaging lines are dedicated to each different drug product or different strengths of the same drug product, or if a 100% examination for correct labeling is conducted by the use of appropriate electronic or electromechanical equipment during or after completion of finishing operations." The compliance office is also considering exempting "manufacturers from the requirement for label reconciliation, if a 100% drug product label inspection system is employed during or after completion of finishing operations." Restated, this would mean that "the requirement for a 100% accountability can be forgone if, in fact, the labels are 100% . . . electronically inspected at the time the labels are employed or after," Michels said. Michels emphasized that there is "no one single solution to the problem . . . A multiplicity of controls appropriate to the type of labeling operations being employed by a firm need to be in place." He added that "substituting roll labels for cut [labels] is not necessarily going to solve the problem. Appropriate printing controls, splicing controls, applications on line, etc., need to go along with that." Michels noted that the agency will take the companies' comments on the proposal "very seriously." He told the industry that if it believes "an inappropriate economic burden is being imposed on you, [that] the agency is off base, tell us that. Tell us what the costs are if you believe that there is a better way of doing business. We will take that into account."