FDA amends packaging/labeling provisions on cGMP regs for drugs

Final ruling goes into effect March 20, 2013; aims to prevent label mix-ups, protect consumers, and eliminate regulatory burden.

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The U.S. Food and Drug Administration on March 20 delivered a final ruling on current Good Manufacturing Practice in manufacturing, processing, packing, or holding of drugs; revision of certain labeling controls. As reported in the Federal Register (https://federalregister.gov/a/2012-6502), the final rule goes into effect March 20, 2013. The Federal Register provides the following online summary of the ruling:

"The Food and Drug Administration (FDA) is amending the packaging and labeling control provisions of the current good manufacturing practice (CGMP) regulations for human and veterinary drug products by limiting the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons. FDA is also permitting the use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed by labeling and packaging equipment when cut labeling is used. This action is intended to protect consumers from labeling errors more likely to cause adverse health consequences, while eliminating the regulatory burden of applying the rule to labeling unlikely to reach or adversely affect consumers. This action is also intended to permit manufacturers to use a broader range of error prevention and labeling control techniques than permitted by current CGMPs."

The Federal Register provided the following background details that initiated last week's final ruling: "Persistent problems with drug product mislabeling and subsequent recalls led FDA in 1987 and in 1990 to review labeling procedures and product recalls. The review identified gang-printed and cut labeling as a leading cause of labeling mix-ups. Gang-printed labeling is defined in § 210.3(b)(22) (21 CFR 210.3(b)(22)) as labeling derived from a sheet of material on which more than one item of labeling is printed. Each sheet includes labeling for a variety of products and, because of this, labeling for individual drug products must be separated from the labeling for other products. When labels are gang-printed, the labels for different drug products or different strengths for the same drug product are processed together, making them especially susceptible to mix-ups. Similarly, cut labeling is commonly placed in separate stacks before being transported to packaging and labeling lines for application to appropriate products. FDA found that stacks of labeling of similar size, shape, and color could easily be intermixed and, if the printer or manufacturer did not detect the error, incorrect labeling could be applied and a mislabeled drug product distributed."
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