For non-sterile compounded medicationssuch as topical creams and oral suspensionsnew guidelines focus on beyond-use dates (BUDs), which are similar to expiration dates.
What are Beyond-Use Dates? Beyond-use dates (BUDs) are the date or time after which a compounded sterile preparation (CSP) or compounded nonsterile preparation (CNSP) may not be stored or transported and are calculated from the date or time of compounding.
As we can see from the illustration, Compounded Pharmacy Regulations Expiration has many fascinating aspects to explore.
The responsibility for assigning the BUD is the compounding personnel, which in most cases equates to pharmacy staff involved in compounding. The BUD is calculated from the date or time of compounding and often requires the professional judgment of a pharmacist.
Epicur must follow the rigorous testing requirements under current good manufacturing practice (cGMP) regulations that allow 503B manufactured medications to have expiration dates of up to 365 days, which are longer than beyond use dates of 503A compounded medications.
This particular example perfectly highlights why Compounded Pharmacy Regulations Expiration is so captivating.
Expiration dates are legally confined to commercial drug products. Beyond Use Dates are for compounded drugs. They do not mean the same thing.
Below is a list of compounding policy documents and related materials. To submit comments to these documents, follow the instructions in the Federal Register notice announcing the availability of...
