In: Nursing
If an expiration date of a medication is May 15, 2018. when is the beyond use date?
Answer:- 15 may 2018 is beyond use date however in emergency it can still be used.
Explanation- Before a drug product is manufactured by a generic
player needs to take an approval from a regulatory authority (FDA
im USA, PMDA of Japan, MHRA of UK).
-These generic players have to prove that their product is
biologically equivalent (Safe, Potent, Efficient) to the brand
product.
-Expiry period is calculated depending upon the behavior of the product under the extremes of the temperature, humidity, acidic and basic condition.
Before entering in to the market the manufacturer need to submit
the Accelerated & Long time study data in which the drug
product was kept in hostile conditions like 40 degrees celsius and
75% RH for 6 Months and 25 degrees celsius and 60% RH respectively
mostly for the US and need to provide the data in continuation once
the product is approved and need to provide many commitments to the
regulatory agencies.
=>Finally coming to the answer, the expiry date can be
considered as 15 may and after 15 may there is a possibility that
the other ingredients added to the drug may produce an Impurity or
degradant which may/may not hamper the patient.
In short, most of the medicines becomes less effective after the expiry date as their potency get reduced and a minimum concentration of drug is must to show any pharmacological action.