Abstract

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.

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Authors

Food and Drug Administration, HHS

Source

Federal register 77:54 2012 Mar 20 pg 16158-63

MeSH

Adverse Drug Reaction Reporting Systems
Drug Industry
Drug Labeling
Drug Packaging
Humans
Medication Errors
United States
United States Food and Drug Administration

Pub Type(s)

Journal Article

Language

eng

PubMed ID

22479732