Magazine article Drug Topics

Should an Rx Label Require a Use-By Date or an Expiration Date?

Magazine article Drug Topics

Should an Rx Label Require a Use-By Date or an Expiration Date?

Article excerpt

For the protection of patients, regulations are enforced to prohibit pharmacies from dispensing or selling expired drugs. In addition, many states have adopted policies that are designed to extend this protection even further.

As pharmacists, we know that the use of a medication before its expiration date ensures maximum potency if it was stored under proper conditions. Once a medication has been dispensed, rhe original manufacturers expiration date cannot always be relied upon and 22 states and the District of Columbia (see table) require the pharmacist to place on the Rx label a "use-by date" or an "expiration date." The "use-by date" is one year from rhe date of dispensing or the expiration date on the manufacturer's container, whichever is earlier. This "use-by date" required by states is similar to the requirements of the 2007 USP/NF, which indicates that in the absence of stability data for a drug product in a repackaged container, the beyond-use dating period is one year from the date of dispensing or the time remaining of the expiration date, whichever is shorter.

Twenty eight states do not require an expiration date on a prescription label and this is also not mandated by federal law. However, even in these states, nothing prevents pharmacists from voluntarily adding an expiration date or beyond-use date to the label and, in fact, certain pharmacies do this as a matter of policy.

Arguments may be made for and against the requirement for an expiration date on the Rx label. For example, the Pharmaceutical Society of the State of New York (PSSNY) has opposed proposed legislation to require expiration dates on the labels of dispensed medications. PSSNY argued that once a medication is removed from its original container and exposed to different storage conditions, the stability of the drug cannot be ensured and thus assigning an expiration date for dispensed medications is impossible. Moreover, since patients are instructed not to store medications for reuse, there is no need for expiration dating on a label.

A counter-argument to the position stated above can also be made. As pharmacists, we are all familiar with patients who do not discard any medication and have "mini-pharmacies" at their homes. These patients may use these stored medications during future episodes of illness. In such a case, an expiration date on the label may prevent patients from using medications rhat have degraded and are no longer suitable for use. Additionally, pharmacists are required by some laws to counsel patients and provide drug storage information to them. …

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