Expiration dating of repackaged medications
FDA’s Federal Register Notice announcing the guidance seeks comments by February 17, 2017.
This record shall include at least the following: (1) Name of drug, strength, dosage form, and quantity; (2) Manufacturer's or distributor's control number; (3) Manufacturer's or distributor's name, if a generic drug is used; (4) Pharmacy control number; (5) Manufacturer's or distributor's expiration date; (6) The pharmacy's expiration date or beyond-use date; (7) Positive identification of the pharmacist responsible for the repackaging of the drug.The advantage of the system is that it keeps the inventory at an optimum level, thus reducing waste.The disadvantages of these systems are the initial purchase cost and an ongoing expense because each container in the machine has to be calibrated to the drug and to the particular brand.FDA’s guidance (like the earlier draft) describes generally the approval process for drugs, including FDA’s required review and approval of drug container closure systems.Trissel's 2 Clinical Pharmaceutics Standard Operating Procedures Formulas Physicochemical Flavorings Discontinued Medications Filter Membrane Compatibility Oral Vehicles Base-Salt-Ester Weight Conversion Na Cl Equivalent Values Veterinary Transdermals p H Adjustment Chemotherapy Vial Reconstitution and Stability Preservatives and Antioxidants Article Search Interactive Claim Form The unit-dose packaged medication system has been available since the 1960s; however, it has become a standard of practice for health-systems in the U. and is required for all JCAHO-certified facilities.Palmer – On December 29, 2016, FDA issued final guidance reflecting its policy on Repackaging of Certain Human (Prescription) Drug Products by Pharmacies and Outsourcing Facilities, first issued in draft form in February of 2015, and blogged here.
FDA’s final guidance highlights certain sections because it includes information still subject to review (collection of information) by the Office of Management and Budget.
These systems are connected with the hospital's computer operating system, inventory system, and/or the dispensing cabinets, such as PYXIS.
When the inventory drops to a certain level from an inventory area or the dispensing cabinets, it sends a message to the automated unit-dose packaging system, and the machine packages only what the area or cabinet needs with barcodes that are readable by the hospital operating system.
(A) Labels of drugs repackaged by and stored within a pharmacy prior to being dispensed shall contain, but not be limited to, the following: (1) Name of drug, strength, and dosage form; (2) The identification of the repackager by name or by the final seven digits of their terminal distributor of dangerous drugs license number; (3) Pharmacy control number; (4) Pharmacy's expiration date or beyond-use date, which shall be within the proven period of stability of the drug.
This expiration or beyond-use date shall be no later than the manufacturer's expiration date of a not previously opened manufacturer's container.
FDA also issued a separate (revised draft) guidance document on repackaging of biological products, which will be the subject of a separate blog post.