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Pharmaceuticals/expiration dating


Hello, Mike! Hope you are doing fine!
We have an OTC product with Deet insecticide and 3 actives for sunscreen items making it SPF 15. We have 3 yr Long term stab studies and 6 months acc. but now we have to reformulate to replace a Prop 65 chem.which means we have to do stability again.
The client does not want to put Expiration date and I don't agree. I also need clarification on what is the equivalent of the accelerated temp.studies. Isn't the 3 months accelerated = tentative 1 years expiration and the 6 months accelerated temp = 2 years expiration? So the 3 years Room Temp stability validates that and equivalent to 2 years expiration ?
Appreciate your clarification on this matter.  THANKS SO MUCH!          LISA

Dear Lisa:

Sorry to inform your client, but if you market an OTC drug in the USA then you must have an expiration date on the product supported by stability studies.

The minimum accelerated stability data that FDA now accepts is 6 months (following their adoption of ICH-Q1 stability guidelines a few years back). And you are correct 3mos gives you 1 year predictive dating; and 6mos gives you two years predictive dating. All accelerated data must be eventually confirmed by room temperature studies.

I hope this helps, stay well,
Michael Anisfeld


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Michael Anisfeld


Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements


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