Published on the Packaging World Web site
| August 31, 1998
FDA is requiring prescription drug labels to bear the words "Rx Only" instead of the former warning: "Caution: Federal law prohibits dispensing without prescription." It's all part of the changes dictated by the FDA Modernization Act.
FDA also repealed the requirement that labels of some habit-forming drugs contain the warning: "Caution: May be habit-forming." The agency significantly extended the deadline for compliance after the pharmaceutical industry protested it would cost over $100 billion to change all the product labels within one year as FDA had proposed. Instead the switch to "Rx Only" for approved drugs can be made at the time of the next label revision or by February 19 2003 whichever comes first. The same timeframe is allowed for unapproved drugs whose applications were submitted before February 19 1998. Labels for drugs whose applications were submitted after that date must comply immediately.
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