Expiration dating of unit-dose repackaged drugs compliance policy guide

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This preview shows page 8 - 12 out of 64 pages. Subscribe to view the full document. I cannot even describe how much Course Hero helped me this summer.

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A guidance issued by FDA on January 12 makes clear that the agency does not favor some long-standing habits of pharmacy personnel related to the repackaging of drug products. Take, for example, the beyond-use date BUD for tablets taken from a manufacturer's large container and repackaged into smaller containers. The BUD of 6 months agrees with the time frame for expiration dating stated by FDA in a decades-old compliance policy guide for unit dose repackaging firms, said Dennis Tribble, an expert in pharmacy operations automation who works for medical device maker BD.

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In recent years the pharmaceutical industry has responded to an increased demand for drug products which are packaged for "unit dose" dispensing, i. The drug product is dispensed in a unit dose container--a non-reusable container designed to hold a quantity of drug intended for administration other than the parenteral route as a single dose, directly from the container, employed generally in a hospital unit dose system. The advantages of unit dose dispensing are that the drug is fully identifiable and the integrity of the dosage form is protected until the actual moment of administration.

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National Library of Australia. Center for Drug Evaluation and Research U. Guidance expiration dating of unit-dose repackaged drugs, compliance policy guide.

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The Public Inspection page on FederalRegister. The Public Inspection page may also include 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.

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The Public Inspection page on FederalRegister. The Public Inspection page may also include 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.

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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 ".

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To date, Form FDA has been submitted in lieu of these forms. Dated: May 17, Jeffrey Shuren, Assistant Commissioner for Policy.

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