For example, a prescription for Cordarone could be labeled as "Cordarone (Amiodarone)" if the brand name was dispensed. The purpose of this rule is to make it possible for hospital personnel to easily identify products from the labels on prescription containers that may arrive with the patient in the emergency department. 1818 provides that prescription labels shall contain the generic name of the drug even if the brand name is in the container. Q: Must a prescription label state the drug's generic name?Ī: Rule. Pharmacists are expected to conform their conduct to these legal requirements. An FDA-authorized IND would "allow the importation, interstate shipment, and administration of the drug even though it is not approved for sale in the U.S." that are refractory to standard therapy." A physician who would like to prescribe domperidone for this indication may contact FDA to open an Investigational New Drug Application (IND). The FDA has long provided clear guidance on this point, which may be found here: Īs FDA’s information further states, "FDA has determined that domperidone should not be compounded or used to enhance breast milk production in lactating women." Domperidone may be useful for "some patients with severe gastrointestinal disorders. Notwithstanding misleading Internet information to the contrary, it is not legal in the United States to acquire, compound, dispense, or administer domperidone outside of an IND. 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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