Assessing Drug Potency After the Expiration Date

Description

Many drugs maintain their potency for some time after the expiration date. Drug companies usually will not issue guidance on use of medications after the expiration date due to legal and financial concerns. Residual potency can be predicted based on the compound, formulation and storage condition.

Parameter	Preserved Potency	Loss in Potency
delivery	tablets or pills	liquids or suspensions, improperly stored
drug stability	stable	labile compound
formulation	proper fillers and buffers	improper fillers, no buffering
appearance	clear	cloudy or with precipitate
storage	as recommended	outside of storage recommendations (too hot or too cold)
humidity	controlled and not excessive	high
seal or packaging	unbroken seal in original container	broken or contaminated

where:

• Change in color can be nonspecific since dyes may change color.

Other concerns:

(1) sterility

(2) appearance

Under proper storage in the original, unopened container, many pills or tablets will retain 90% of their potency for 5 or more years after the expiration date.

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Description

Specialty

ICD-10