expiration dating of unit-dose repackaged drugs

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The Public Inspection page on FederalRegister. The Public Inspection page may also expiration dating of unit-dose repackaged drugs documents scheduled for later issues, at the request of the issuing agency. The President of the United States manages the operations of the Executive branch of Government through Executive orders. The President of the United States communicates information on holidays, commemorations, special observances, trade, and policy through Proclamations. The President of the United States issues other types of documents, including but not limited to; memoranda, notices, determinations, letters, messages, and orders.

Unit dose packaging systems are currently widespread in health care. The nature of drug distribution within hospitals in particular has made such packaging useful and convenient in assuring proper administration of medication to patients. Questions have arisen, however, as to whether drugs thus repacked need expiration dates based on stability data on the drugs in the unit dose containers. 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. The Current Good Manufacturing Practice Regulations require that, with certain expiration dating of unit-dose repackaged drugs, drug products must bear expiration dates derived from tests conducted on samples stored in the same immediate container closure system in which the drug is marketed. 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. No action will be initiated against any unit dose repackaging firm, including shared services, or drug product in a unit dose container meeting all other conditions of FDA's repackaging requirements solely on the basis of the failure of the repackaging firm to have stability studies supporting the expiration dates used, provided:.

The U. The FDA states that this action was taken in response to " an increasing demand in various health care settings for solid oral dosage form drug products repackaged into unit-dose containers, which hold a quantity of drug for administration as a single dose. The increase in unit-dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products ". In addition, expiration dating of unit-dose repackaged drugs final, it will supersede Compliance Policy Guide Comments regarding the draft document should be submitted within 60 days of publication.
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