Usp 797 beyond use dating

Posted by / 04-Oct-2020 03:41

Usp 797 beyond use dating

However, reliable, published stability information is sometimes lacking for many types of drugs.In these instances, pharmacists should consult with the drug's manufacturer to establish a beyond use date.Direct extrapolation of the information to the specific compounded formulation requires that the scientific study data utilize the same drug source, the same drug concentration, and the same compounding procedures, stores the formulation in the same container, and has subjected the formulation to the same anticipated environmental variables.

For example, a higher concentration of drug may be prescribed; different diluent, container, etc., may be necessary; or the patient may require the HSD for longer periods of time.

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.

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.

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The major problem for pharmacists is that the stability of compounded formulations often is not known.