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FDA Guidance Drafts on Design and Labelling

June 15th, 2015 Posted by Coding Canada Team

We understand some Canadian manufacturers and co-packers export products into the United States and that they keep up to date with the rules and regulations in US markets.  Recently, FDA released two safety drafts on product designs and carton and container labeling.  These drafts are intended to act as guidance to manufacturers and co- packers in the pharmaceutical industry.  After reading an article in the “Pharmaceutical and Medical Packaging News” magazine, where the writer highlights some parts of the drafts by the FDA as well as provides insights from a representative from the FDA’s Division of Medical Errors Prevention and Analysis (DMEPA), we’ve decided to share with our audience parts of that article as well as links to the original drafts by the FDA.

To have some context about the statements by the DMEPA representative in the magazine’s article, we outline the role of the institution itself: DMEPA works with the pharmaceutical industry to provide solutions that reduce the risk of medication errors in the industry. The definition of medical errors which DMEPA uses is “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer”.  Printing poor quality expiration dates on packages is a preventable event.  We recommend using one of our Linx date coders to print and mark clearly on various substrates.

The writer of the magazine article, “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors” reports that the FDA draft provides “specific direction on ideal approaches to package and label design”.  She notes that part of an ideal approach is that the expiration date must be prominently displayed, and that this is also a requirement of the U.S. Pharmacopeial Convention (USP). Other features which must be displayed prominently on the “Principal Display Panel” include: proprietary drug name, established drug name, and product strength. Canadian manufacturers and co-packers pay particular attention to specifics such as the 12 point san serif font recommended in the article.  It is also critical to learn what the FDA recommends to avoid when labeling pharmaceutical products and cartons. The DMEPA representative sheds light on this by saying the FDA “discourages the use of logos, bars, stripes, lines, symbols, watermarks, and graphics,”. And she recommends not to “superimpose text over images or logos, and images of tables should not compete in size or prominence” with prominent features on the packaging.

Please see references below:

Pharmaceutical and Medical Packaging News. May/ June 2014. Vol. 22 issue 3. Pg 24.

http://www.fda.gov/drugs/drugsafety/medicationerrors/

 “Safety Considerations for Product Design to Minimize Medication Errors”. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm331810.pdf

 “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors”.

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm349009.pdf

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