Fda beyond use dating CPG Sec. 480.200 Expiration Dating of Unit Dose Repackaged Drugs

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The expiration date will ensure that the products meet applicable standards of identity, strength, quality, and purity at the time of use. The facility in which repackaging is practiced should be operated in conformity with cGMPs.

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These functions are beyond the regular practice of a pharmacist. The BUD used for the repackaged product does not exceed 6 months from the date of repackaging.

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We will continue to impose all requirements on other dosage forms and other types of packages. For multiple-unit packaging, the following criteria should be considered in assigning a BUD. Any alteration or manipulation of the repackaging process should be documented in accordance with the requirements in 21 CFR It does not apply to repackaging of any radioactive drug products, including oral solids.

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For products identified by the manufacturer as moisture- and temperature-sensitive, the repackager must follow the specifications provided by the manufacturer during repackaging, shipping, and distribution.

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.

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This policy does not apply to antibiotics or to nitroglycerin sublingual tablets which are known to have stability problems that preclude them from being repackaged. The conditions of storage meet the storage specifications provided in the General Notices and as described in the labeling by the manufacturer of the bulk product.

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Drugs repackaged by outsourcing facilities must include required information on their labels and meet other requirements of B, including adverse event reporting pages If the drug is a non-sterile product repackaged by a beyond use dating use dating licensed pharmacy, federal facility, or outsourcing facility: This record should also include the name of the manufacturer or supplier and its lot numbers and the date of receipt.

A repackager is expected to repack penicillins, or products such as penicillins, in facilities separate from those facilities used for drug products as described in 21 Dating sites free for ladies 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. The repackager is expected to perform appropriate analytical testing for all pertinent specifications, such as identity and strength of each active ingredient, and any other finished product tests to establish valid analytical data.

Skip to main page content Skip to search Skip to topics menu Skip to common links. For example, if the manufacturer packages in glass, the repackager should repackage in glass of the same type used by the manufacturer or in chemical-resistant glass containers.

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Where no specific storage conditions are specified, the product should be maintained at controlled room temperature and in a dry place during repackaging.

The unit dose container complies with the Class A or Class B standard described in the twentieth Edition of the United States Pharmacopeia, General Tests, Single-Unit Containers and Unit-Dose Containers for Capsules and Tablets page The expiration date does not exceed six months; and The six month expiration period does not exceed 25 per cent of the remaining time between the date of repackaging and expiration date shown on the original manufacture's bulk container of the drug repackaged, and the bulk container has not been previously opened.

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The BUD does not exceed the manufacturer's expiration date. For all other products, the repackager should follow the same guidelines provided in Good Storage and Shipping Practices that are applicable to a manufacturer.

This website has been translated to Spanish from English, and is updated often. Sterile drug products repackaged by state-licensed pharmacies or federal facilities If the repackaged product is an FDA-approved drug product with a specified in-use timethen the repackaged drug must be assigned a BUD that is established in accordance with the in-use time on the product or the expiration date on the product, whatever period is shorter.

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Readers should be aware that HPM represents many companies in the food, drug, medical device, and health care industries, and therefore FDA Law Blog may occasionally report on news that relates to HPM clients. This chapter is beyond use dating to provide guidance to those beyond use dating in repackaging of drug products in accordance with 21 CFR The environmental conditions during the packaging and storage operation of the drug product should comply with the controlled room temperature see General Noticesstorage in a dry place, and other requirements as directed by the manufacturer or supplier, especially if the drug requires storage at special temperature and humidity conditions see Good Storage and Shipping Practices For the purposes of this chapter, repackager, contract packager, and contract repackager are defined as follows.

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.