Dating of multi use containers
It’s beyond me how the state board can interpret a stock bag differently from any other low-risk or medium-risk level CSP, but they are.
At least that’s how things are in California at the moment. Does that still count if one uses a CSTD or other port that prevents re-entry via the stopper?
Opened or needle-punctured single-dose containers, such as bags, bottles, syringes, and vials of sterile products and CSPs shall be used within 1 hour if opened in worse than ISO Class 5 air quality, and any remaining contents must be discarded.
Single-dose vials exposed to ISO Class 5 or cleaner air may be used up to 6 hours after initial needle puncture.
The BOP sets standards, roles, and requirements for pharmacy personnel and practice setting in their state.
Occupational Safety and Health Administration (OSHA) - OSHA is a government agency within the United States Department of Labor responsible for maintaining safe and healthy work environments.
Until things are sorted out, you’re better off going with six hours.
While I do not agree with treating a stock bag as a single-dose container, it is wise to follow current best practice when it comes to the board of pharmacy.
Crud, even compounds prepared in high-risk conditions get 24 hours at controlled room temperature.The Joint Commission (TJC) - The Joint Commission, formerly the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is a nonprofit organization that accredits more than 20,000 healthcare organizations and programs in the United States.Board of Pharmacy (BOP) - Each state has its own board of pharmacy.The basic understanding for CSTDs is that they should not be used to extend BUD.However, does this prevent multiple entries into the bag by creating a sealed barrier between the product and the direct compounding area (DCA)? It is interesting to note that the media-fill test procedure for low-risk compounding includes transferring four 5-m L aliquots of TSA into a single 30-m L vial. A CSP prepared under low-risk conditions receives a 48 hour BUD when stored at controlled room temperature.
So if you were to prepare a single ingredient stock bag and leave it in the hood, why not give it 48 hours?