Expiry dating of pharmaceuticals

expiry dating of pharmaceuticals

How to calculate the expiry date of a drug product?

The expiry date of a drug product should not exceed the expiry date of the drug substance. The expiry date for a batch of finished product shall be calculated from date of manufacture of product.

How are expiration dates established in the FDA?

2. How are expiration dates established? FDA regulations require drug applicants to provide stability testing data with a proposed expiration date and storage conditions when they submit an application for FDA approval of their drug.

Can you take drugs after the expiration date?

Drug manufacturers never support the use of drugs after the expiration date because that could make them liable if something went wrong. The expiration date printed on drug packaging will differ from the true expiration date of the drug. Before the true expiration of a drug, its active ingredient will retain its potency.

Is expiration dating required for bulk drugs under the cGMP?

While expiration dating is not required specifically for bulk drugs in the CGMP regulations, it is feasible and valuable to expect the manufacturer of bulk drug substances to assure that their product is stable for the intended period of use.

What is the expiry date of a drug product?

If the date of manufacture of a drug product is 5 Dec ‘2016, and the drug product has a shelf life of 2 years, then the date of expiry shall be Nov ‘2018. Similarly if date of manufacture of a drug product is 31st Dec ‘2016 and drug product has a shelf life of 2 years, then the date of expiry shall be Nov ‘2018.

Do reconstituted drugs have expiration dates?

Any drug product intended for reconstitution and not bearing an expiration date for the unreconstituted product and another expiration date for the product after reconstitution is considered to be out of compliance with 211.137 (c). There must be separate stability studies to support each expiration date.

How do you determine the expiration date of a product?

This can be done, as an example, by taking a sample product that has been at room temperature for one year and subjecting that sample to accelerated temperature conditions. The expiration dating period used would then be the sum of that justified individually at each storage condition.

When is a drug product out of compliance with 21 CFR?

Any drug product intended for reconstitution and not bearing an expiration date for the unreconstituted product and another expiration date for the product after reconstitution is considered to be out of compliance with 211.137 (c). There must be separate stability studies to support each expiration date. STABILITY TESTING (21 CFR 211.166)

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