Expiration dating fda guidance
Index
- How are expiration dates established in the FDA?
- Why do drug labels have expiration dates?
- Can a manufacturer extend the expiration date of a drug product?
- When is a drug product out of compliance with 21 CFR?
- How long is a product good after expiration date?
- How long is a drug good after expiration date?
- What do expiration dates actually mean?
- Do reconstituted drugs have expiration dates?
- When is a drug product out of compliance with 21 CFR?
- Can I use expired medical products?
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.
Why do drug labels have expiration dates?
Drugs, including those that are both drugs and cosmetics, must be tested for stability (see the regulations at 21 CFR 211) and are required to have expiration dates printed on the labels. Manufacturers must make sure their drug products are safe and effective until their expiration dates.
Can a manufacturer extend the expiration date of a drug product?
The manufacturer of an approved drug product may extend the expiration date for the drug product based on acceptable data from full, long-term stability studies on at least three pilot or production batches in accordance with a protocol approved in the NDA or ANDA.
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)
How long is a product good after expiration date?
If it floats, youve got a rotten egg on your hands, and if not, you’re good to go. Eggs often pass this test even two weeks after their date. With unopened processed foods like cereal and chips, you can get away with eating them months after the expiration date.
How long is a drug good after expiration date?
The expiration date is only an assurance that the labeled potency will last at least until that date. Ongoing research shows that stored under optimal conditions, many drugs retain 90% of their potency for at least five years after the labeled expiration date, and sometimes longer.
What do expiration dates actually mean?
These dates tell you the recommended shelf life for the best flavor, color, and quality of a product. The food can safely be used past this date. In the case of our salsa, it can be used up to 18 months past the date or possibly longer. “Sell By”. These dates tell the store how long they should display the product for sale.
