What is drug repackaging?
Repackaging, Generally. FDA regards repackaging as the act of taking a finished drug product from the container in which it was distributed by the original manufacturer and placing it into a different container without further manipulation of the drug.
Who manufactures Isentress?
Merck, the manufacturer of Isentress, also offers a Isentress manufacturer coupon to eligible patients. This savings coupon provides a discount to patients up to a maximum of $6800 on 12 prescriptions.
Does Isentress need to be dispensed in original container?
ISENTRESS for oral suspension: Store in the original container. Do not open the foil packet until ready for use.
Can OTC drugs be repackaged?
Except for single-dose vials, the drug must be repackaged in a way that does not conflict with approved labeling. However, the guidance notes (unlike the draft) that the repackaging must be in accordance with the handling or storage instructions for the approved product so as to not conflict with approved labeling.
Is there a generic for Isentress?
There is currently no generic alternative to Isentress.
What class of drug is Isentress?
General Info. Isentress is an HIV medication. It is in a category of HIV medicines called integrase inhibitors.
Is repackaging considered compounding?
Repackaging: Transferring medications from one container to another without making any changes, such as drawing up syringes from a larger container, is repackaging, not compounding.
Which of the following is required to be documented when repackaging?
Records must include the date of repackaging medication, prescription name, physician who will be dispensing the medicine, and drug name. The strength of the drug must be listed, as well as the quantity. These steps must be verified and signed by an authority figure in the repackaging company.
Can you cut Isentress in half?
Raltegravir Isentress Film coated tablets should not be chewed, crushed or split due to anticipated changes in the pharmacokinetic profile.
Why does prasugrel need to be dispensed in original container?
Medication Guide: “Keep and dispense only in original container,” in order to maintain consistency with the revised Effient container labels. 2. Information should be added to Section 17 (PATIENT COUNSELING INFORMATION) of the FPI and the Medication Guide to emphasize that the tablets should not be broken.