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Expression of expiration dates on labels needs to be standardized

From the June 2, 2005 issue

To assure that a drug meets standards of identity, strength, quality, and purity before use, the US Code of Federal Regulations (CFR) (Part 211) sets forth the conditions under which an expiration date must be listed on labels. With few exceptions, companies must list an expiration date on the immediate container and any outer package if the date is not legible through the outer packaging. When single-dose containers are packed in individual cartons, the expiration date may appear on the carton instead of the immediate container. Unfortunately, the CFR does not specify how expiration dates must be expressed. Thus confusion sometimes occurs.

Axcan Scandipharm lists JN05 as the expiration date on a CANASA (mesalamine) suppository package label, but does it mean January or June? 

LACTAID ORIGINAL, distributed by McNeil Nutritionals, uses another atypical abbreviation for April; AL 05 means April 2005.

The Aventis Pasteur poliovirus vaccine (inactivated) listed an expiration date of 06 MAR 04. However, practitioners became confused as to whether it meant the drug expired on March 6, 2004, or March 4, 2006.

In the latter case, problems did not arise until 2001. For example, when “99” appeared with “05,” it was clear that the year of expiration was 1999. Before 2001, the year could not be mistaken as a day; now, the numbers used for the day and year may overlap until 2032.  

A medication error has occasionally resulted from a misinterpreted expiration date. For example, a night nurse thought that vials of magnesium sulfate had expired. The expiration date was listed as 1-06, but the product lot number, 2002, appeared right before the expiration date. Not knowing that 2002 was a lot number, the nurse thought the drug expired on 1/06/02, thus delaying treatment.

Similar problems may occur with over-the-counter (OTC) products. Under the CFR, expiration dates for OTC products are not enforced if their labeling does not bear dosage limitations, and if they are stable for at least 3 years. When they do appear, expiration dates may be difficult to decipher. For example, RESOURCE BENECALORIE, a medical food supplement (Novartis Nutrition), does not list an expiration date but uses a 4-digit code for the month and year of production (e.g., 0504 for May 2004). This has been misinterpreted as an expiration date. While not listed in the packaging, the user is supposed to add 270 days to the production date for the expiration date.

In the 2005 USP–National Formulary General Notices (page 11), expiration dating is addressed in a way that might facilitate FDA’s ability to clarify the above ambiguity. Under Expiration Date and Beyond-Use Date, it states: “The label of an official drug product or nutritional or dietary supplement product shall bear an expiration date. All articles shall display the expiration date so that it can be read by an ordinary individual under customary conditions of purchase and use. The expiration date shall be prominently displayed in high contrast to the background or be sharply embossed, and easily understood (e.g., “EXP 6/89,” “Exp. June 89,” or “Expires 6/89”).” 

The Consumer Healthcare Products Association (CHPA) has also published “Voluntary Codes and Guidelines of the OTC Medicines Industry,” which offers specific procedures related to the display, location, and legibility of expiration dates; expiration statements that are understandable to consumers (e.g., “Exp 6/99,” “Expires 6/99”); the avoidance of packaging features that might interfere with the legibility (e.g., end seals on shrink-wraps); and emerging technologies for the application of expiration dating (e.g., improved debossing techniques, advances in ink printing). Clearly, standards are needed for expressing dates in a uniform sequence that does not confuse the practitioner or patient.


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