N expiration dating period

n expiration dating period

How do you justify an expiration dating period of more than 3 years?

The use of accelerated testing data to establish a tentative expiration dating period of greater than three years is discouraged when it is based solely on accelerated data. Combining data compiled at room temperature and at accelerated temperature is possible to justify an expiration dating period of over two years.

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.

How to extend the expiration date of a drug product?

Expiration Dating Extension 1 Approaches to Drug Product Expiration Date Extensions. The manufacturer of an approved drug product may extend the expiration date for the drug product based on acceptable data from full, long-term ... 2 MCM Expiration Dating Extensions. ... 3 Additional Information. ...

What does the expiration date on a medical product mean?

A medical product is typically labeled by the manufacturer with an expiration date. This reflects the time period during which the product is expected to remain stable, or retain its identity, strength, quality, and purity, when it is properly stored according to its labeled storage conditions.

How do I justify an expiration date over two years?

Combining data compiled at room temperature and at accelerated temperature is possible to justify an expiration dating period of over two years. 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.

How to extend the expiration date of a drug product?

Expiration Dating Extension 1 Approaches to Drug Product Expiration Date Extensions. The manufacturer of an approved drug product may extend the expiration date for the drug product based on acceptable data from full, long-term ... 2 MCM Expiration Dating Extensions. ... 3 Additional Information. ...

What is the difference between expiration date and period after opening?

In cases where the shelf life exceeds 30 months an expiration date is not required to be placed on the packing, however a period after opening (PAO) is. Period after opening (PAO) refers to the amount of time a product will remain stable and safe for human use after it has first been opened.

Can accelerated testing data be used to estimate expiry dates?

The use of accelerated testing data to establish a tentative expiration dating period exceeding three years is discouraged when it is based solely on accelerated testing data. Based on the combination of data collected at room temperature and at accelerated temperature, it is possible to justify an expiration dating period of over two years.

What does the expiration date on a medication mean?

Neither fully explains what the expiration date means. Actually, its the date up until which the drug manufacturer can guarantee that the medicine is fully potent and safe to take based on product testing. Expiration dates are typically conservative to make sure you get what you paid for—a fully potent and safe medicine.

Is it safe to use expired medical products?

Because using expired medical products may potentially harm our health, in the late 1970s the United States Food and Drug Administration (FDA) mandated that all prescription and over-the-counter (OTC) medical products contain an expiration date.

Why do implantable medical devices have expiration dates?

Implantable medical devices containing highly sophisticated electronics are lasting longer than before, raising the bar for safety and liability. The concept of an expiration date was created to help consumers realize when a product should be discarded.

What is the meaning ofexpiration date?

DEFINITION of Expiration Date. Expiration date is the date after which a consumable product such as food or medicine should not be used because it may be spoiled, damaged or ineffective.

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