Basics of sterile compounding criteria for determining beyond-use dating

How to determine beyond-use date of sterile compounds?

Basics of Sterile Compounding: Criteria for Determining Beyond-use Dating Compounding pharmacists must separately and collectively evaluate multiple aspects of a compounded sterile preparation when determining their beyond-use date.

What are the USP compounding standards and beyond-use dates?

USP Compounding Standards and Beyond-Use Dates (BUDs) On June 1, 2019, USP published updates to the USP General Chapters on compounding nonsterile and sterile preparations alongside new standards for compounding radiopharmaceutical drugs.

What is a bud for compounded sterile products?

3. A BUD is assigned by the pharmacy for a compounded sterile product (CSP) 4. The BUD for a CSP identifies the time by which the preparation – once mixed – must be used before it is at risk for chemical degradation, contamination, and permeability of the packaging.

How can we improve sterile compounding?

In an effort to improve sterile compounding across a multihospital system, we developed and implemented beyond use dating guidelines to improve consistency and patient safety while meeting regulatory concerns.

What does beyond use date mean for sterile compounding?

BEYOND USE DATING FOR STERILE COMPOUNDING. Beyond Use Date (BUD) is very different from expiration date. USP Chapter 797 defines BUD as the date or time after which a compounded sterile preparation (CSP) may not be stored or transported and is calculated from the date or time of compounding.

What are the requirements for compounding sterile preparations?

Murdaugh: Depending on your location, some state boards of pharmacy and departments of health have more stringent requirements regarding compounding sterile preparations, which encompass the assignment of BUDs and required quality control testing.

What are the USP compounding standards and beyond-use dates?

USP Compounding Standards and Beyond-Use Dates (BUDs) On June 1, 2019, USP published updates to the USP General Chapters on compounding nonsterile and sterile preparations alongside new standards for compounding radiopharmaceutical drugs.

What is a bud for compounded sterile products?

3. A BUD is assigned by the pharmacy for a compounded sterile product (CSP) 4. The BUD for a CSP identifies the time by which the preparation – once mixed – must be used before it is at risk for chemical degradation, contamination, and permeability of the packaging.

What is sterile compounding?

Sterile compounding is further defined by USP to include any manipulation of a sterile or nonsterile product intended to produce a sterile final product. The Food and Drug Administration (FDA) recognizes compounding as a part of pharmacy practice, which does not fall within the agency’s authority.

Who is responsible for sterile compounding inspections?

Oversight for sterile compounding practice falls primarily to the states and is typically governed by the individual state’s board of pharmacy, however the Food and Drug Administration (FDA) also maintains authority to inspect pharmacies for insanitary conditions.

What is an example of a sterile product?

Sterile products, on the other hand, must be compounded in such a way to produce as clean of a product as possible. Examples of sterile products include ophthalmic solutions, injectables, or parenteral nutrition. [4]

What are the new USP chapter revisions for compounding in 2019?

On June 1, 2019, USP published revisions to general Chapters <795> for non-sterile compounding and <797> for sterile compounding. General Chapter <825> was introduced for radiopharmaceutical compounding.