What is the expiration date for bubble packs containing one chemical entity?

The correct answer is determined by the regulations surrounding the expiration of medications in bubble packs, which often contain single chemical entities. The expiration date is defined as either one year from the date of dispensing or the manufacturer's expiration date, whichever is sooner. This regulation is important because it ensures that patients receive medications that are effective and safe to use, while also taking into account any specific stability data provided by the manufacturer.

When bubble packs are prepared by pharmacies, they may not always include the manufacturer's expiration dating, especially when the product is repackaged. Therefore, the one-year guideline acts as a standard safeguard to prevent the dispensing of older medications that may have reduced efficacy. This policy is in place to promote patient safety, as medications beyond their effective date may not provide the intended therapeutic benefits.

It's important to recognize that the manufacturer's expiration date may be shorter than one year, and in such cases, the bubble pack would expire based on the manufacturer's designation. Thus, the approach of utilizing the shorter of the two dates serves to protect patients by ensuring they are not using medications that may no longer be up to standard in terms of potency or safety.