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They will contact you with further actions that could possibly be taken. Do you think this will bankrupt us all and put compounders out of business? Type of Posting: Notice of Intent to Revise Posting Date: 25—Sept—2015 Expert Committee: Compounding In accordance with section 7. This request may take up to 48 hours to be processed.

One other point in that often gets misinterpreted is the testing of compounds according to batch size. We, myself included, historically have given 180 day beyond use dating to our products without a second thought and no real scientific data to back up that claim. Should you have any questions, please contact Rick Schnatz, Pharm.

Get your USP-NF subscription key - The General Chapter Pharmaceutical Compounding—Nonsterile Preparations Revision Bulletin supersedes the currently official General Chapter. One other point in that often gets misinterpreted is the testing of compounds according to batch size.

Beyond Use Date vs Expiration Dating The system that most pharmacies use to assign a date beyond which it should no longer be used seems to be a point of confusion. We, myself included, historically have given 180 day beyond use dating to our products without a second thought and no real scientific data to back up that claim. With the previous version there was quite a bit of confusion and they made reference to for direction. Polyethelyne Glycol degrades to Diethylene glycol which is a great solvent but basically starts shutting down biological systems liver kidney in humans. I try to take a common sense approach on all of this and come to logical conclusions. One other point in that often gets misinterpreted is the testing of compounds according to batch size. Does that actually make any sense? Is the probability of contamination lower? It only takes a single bacterial cell or fungi to get into 1 bottle of 1 compound to have very detrimental effect on a patient. Are these studies and tests expensive? If we take the initiative to start performing some of these quality measures on our own, the industry as a whole will be taken more seriously. It can only benefit everyone involved in the end; most notably: the patient. You could also leave me a to ask a question. Do you think this will bankrupt us all and put compounders out of business?

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Beyond Use Date vs Expiration Dating The system that most pharmacies use to assign a date beyond which it should no longer be used seems to be a point of confusion. This request may take up to 48 hours to be processed. The chapter provides information for a variety of determinations, including quantities of ingredients, dosages, infusion rates, endotoxin load, stability and expiration dates, and provides illustrative sample calculations. One other point in that often gets misinterpreted is the testing of compounds according to batch size. The chapter will describe considerations such as training, facilities, equipment and components, release testing, quality assurance, quality control and documentation for compounding investigational preparations.