Fda beyond use dating, inspections, compliance, enforcement, and criminal investigations
In light of these standards, under certain conditions the Food and Drug Administration would not ordinarily deem it necessary for health protection, nor for assurance of stability of the drug, to require that stability studies be done on the drug in the unit dose container.
Establishing the expiration date in the case listed in c is beyond use dating for unit-dose containers, multiple-unit containers, and unit-of-use container types. The following represents the minimum requirements a repackager must meet in order to engage in repackaging drugs from their original manufacturer's container. The drug may not be sold or transferred by an entity other than the entity that repackaged the drug but does not include administration of a repackaged drug in a healthcare setting.
These functions are beyond the regular practice of a pharmacist. The bulk article should be distributed to the repackager by the manufacturer in accordance with all regulatory requirements and accompanied by appropriate labeling and a valid expiration date. The BUD used for the repackaged product does not exceed 6 months from the date of repackaging.
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For multiple-unit packaging, the following criteria should be considered in assigning a BUD. The packaging materials should comply with 21 CFR food additives regulations and all applicable requirements in USP general chapters, and For all products, if the repackager uses a container that is equivalent in MVTR to the manufacturer's container or one that has a higher barrier, then the BUD should be 12 months or the manufacturer's expiration date, whichever is less.
The contents of the original bulk drug product to be repackaged are repackaged at one time. The repackager may not use the expiration date and BUD interchangeably because they imply the presence or absence of stability testing, respectively. The General Notices define multiple-unit packaging as a package that contains more than one single-dosage unit.
Records should be maintained to verify the identity and quantity of each shipment received and to verify the lot number and bar coded information for each article of the bulk shipment received. The BUD does not exceed the manufacturer's expiration date. The container meets or exceeds the manufacturer's container in special protective features: For moisture-sensitive products, a higher-barrier container should be used for repackaging.
When a drug is repackaged into a different container, the product's expiration date is altered or interrupted.
A repackager is expected to meet the requirements of packaging practice under 21 CFR through Concerning the issue of repackaging into unit dose containers, we interpret compliance with the conditions enumerated in this guide to meet the stability requirements of the CGMP regulations. Thank you for visiting esp. The original bulk container of the drug product to be used for repackaging has not been previously opened. The conditions of storage meet the storage specifications in the General Notices and as described in the labeling of the manufacturer's bulk product.
The nature of drug distribution within hospitals in particular has made such packaging useful and convenient in assuring proper administration of medication to patients. Because the packaging practice relates to packaging, processing, or beyond use dating a drug product intended for administration to humans or animals, the repackager is expected to comply with regulations such as those relating to the sections pertaining to beyond use dating control, personnel qualifications, building and facilities, equipment, production and process controls, packaging and labeling controls, laboratory controls, master production record, batch records and reprints, distribution records, storage control records, and complaint files.
It is possible that some links will connect you to content only available in English or some of the words on the page will appear in English until translation has been completed usually within 24 hours. The most significant changes between the draft and final guidance address beyond use dating BUD for repackaged products: This website has been translated to Spanish from English, and is updated often. The unit-dose container meets or exceeds the manufacturer's specification for light resistance. We will continue to impose all requirements on other dosage forms and other types of packages.
The repackaging container should show the equivalent of, or be better in protective properties than, the manufacturer's original container. The contents of the original bulk drug product to be packaged are repackaged at one time.
PS05 Packaging and Storage Written procedures should be maintained to ensure that correct labels, labeling, and packaging materials are used for drug products.
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