9/9/2023 0 Comments Swish and swallow nystatin![]() Accordingly, any domperidone product dispensed in the United States outside of an IND is unapproved, adulterated and misbranded under both federal and North Carolina law. ![]() Domperidone is not a drug approved for human use in the United States. ![]() Q: Is it permissible to compound domperidone?Ī: Domperidone compounding is permissible only as part of an investigational new drug application (IND). The addition of flavoring including the flavor manufacturer or product, lot number, and expiration date must be documented in the patient record notes for the prescription. pyridostigmine oral solution), then the BUD is 35 days in controlled room temperature or refrigerated or shorter if indicated in the manufacturer’s labeling. If a flavoring component is added to a manufactured product that contains a preservative (e.g. If a flavoring component is added to a manufactured product that does not contain a preservative (e.g.: reconstitution of amoxicillin oral suspension) the BUD is 14 days refrigerated or shorter if indicated in the manufacturer’s labeling. If a pharmacy adds flavoring to a manufactured product it must take into account the manufacturer’s Beyond Use Date (BUD) and the effect on stability caused by adding flavoring. Q: Is adding flavoring to a conventionally manufactured product considered compounding?Ī: USP considers adding flavoring to a conventionally manufactured product to fall within the scope of compounding, because there are known instances when flavoring components have destabilized a product. Frequently Asked Questions for Pharmacists on Compounded Products/Compounding
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