Determining Drug Product Shelf Life

FDA Registered 503B Outsourcing Facility

Posts by Fagron Sterile Services

Determining Drug Product Shelf Life

Occasionally I get asked why a compounded product does not have an expiration date as long as that of a manufactured product. Expiration dates are required by the FDA for commercially manufactured products and are determined after years and years of extensive study of the product’s stability. Most expiration dates are expressed in years for…

Read More

3 Options to Meet USP 797 Requirements for Combination Ophthalmic Dilating Drops

Dilating patients’ eyes before ophthalmic procedures is quite possibly the most time-consuming part of the eye exam/surgery. Many facilities choose to combine various medications to ensure a more efficient pre-operative process. While this practice creates efficiencies for nursing staff and perhaps is less burdensome for patients, the risk of contamination during mixing of these medications…

Read More

Choosing the Correct Type of Sterile Compounding Pharmacy

As a high-risk sterile compounder, I routinely run into confusion over the different types of sterile compounding. Not all compounders are the same and understanding the differences is an important first step in picking a compounder that can meet your needs. Do you need a smaller-sized, unit-of use, prefilled syringe of a medicine that is…

Read More

Clearing Up Epidural Steroid Injections – Part II of II

I received a call recently from a surgery center looking for an intrathecal injection containing morphine, clonidine, and baclofen. Appropriately, the caller was adamant that this product contain no preservatives since it is to be delivered via the intrathecal route. However, when I asked if the center was using epidural steroid injections the caller commented…

Read More