Beyond-use-date

Whereas commercially manufactured products are required to possess an expirahon date, compounded products are assigned a beyond-use date. There are numerous sources of information that can be used for determining an appropriate beyond-use date, such as chemical companies, manufacturers literature, laboratory data, journals, and published books on the subject. Generally, most pharmacists prepare or dispense small quanhties of compounded products recommend storage at room, cool, or cold temperatures and use a conservative beyond-use date. 

In the absence of stability information that is applicable to a specific drug and preparation, the following maximum beyond-use dates are recommended for nonsterile compounded drug precautions that are packaged in tight, light-resistant containers and stored at controlled room temperature unless otherwise indicated. ... 

For nonaqueous liquids and solid formulahons (for which the manufactured drug product is the source of active ingredient), the beyond-use date is not later than 25% of the hme remaining unhl the product s expiration date or 6 months, whichever is earlier ... 

When a USP or NF substance is the source of achve ingredient, the beyond-use date is not later than 6 months ... 

These beyond-use date limits may be exceeded when there is supporting valid scientific stability information that is directly applicable to the specific preparation (i.e., the same drug concentration range, pH, excipients, vehicle, water content, etc.)... 

The use of pharmaceutics and most of the pharmaceutical or physicochemical factors involved in formulation of these products are identical. One exception, however, is the shorter beyond-use dates assigned to compmmded preparations as compared to expiration dates for manufactured products. A second notable exception is that commercially manufactured products are developed over several years whereas an extemporaneously compounded preparation may be required for a specific patient in a matter of minutes or hours. 

USP <797> Pharmaceutical Compounding-Steiile Preparations - Storage and Beyond-Use Dating. .. quantitative stability-indicating assays, such as high performance liquid chromatographic (HPLC) assays, would be more appropriate for certain Compounded Sterile Preparations... 

Beyond use dating is used for those products that are changed hy the addition of another substance thereby affecting the stability of the product. For these products the pharmacist should include the date beyond which the product would not be deemed to be stable and effective. An example of this is an amoxicillin suspension that is stable for 10 days in the refrigerator. The manufacturer s expiration date of the amoxicillin suspension is greater than 10 days however, the addition of water to the product makes the product unstable after 10 days. Compounded products are intended for immediate use and should contain a beyond use date that does not extend beyond the manufacturer s expiration date of the products. 

Pharmacists dispensing solid oral medication may use their discretion as to the beyond use dating for the product. It cannot exceed the expiration date stated on the manufacturer s label. There is no Federal requirement that expiration dates be included on the prescription label prior to dispensing to the consumer. The FDA does require beyond use dating for drug products dispensed to patients in long-term care facilities. 

Packaging is appropriate for sterility and stability until the beyond use date. 

Beyond use dates are utilized based on appropriate scientific criteria. 

What type of facilities does the FDA require the use of beyond use dating in ... 

Peacock GF, Sauvageot J. Evaluation of the stability of acetaminophen in pluronic lecithin organogel and the determination of an appropriate beyond-use date. Int J Pharm Compd. 16(5) (2012) 428-430. 

Unless otherwise justified, aqueous ear preparations supplied in multidose containers contain a suitable antimicrobial preservative at a suitable concentration, except where the preparation itself has adequate antimicrobial properties. An example of this is Bacicoline B . These ear drops contain a borate buffer, but no preservative. This was accepted by the licensing authorities because borate buffers have some antimicrobial properties and because the beyond-use date is 10 days after opening. 

According to national legislation the label mentions the dosage form (eye cream or eye ointment), the route of administration (ocular use), the intended use, the storage conditions, the expiry date and, for multidose containers, the beyond-use date after which the opened preparation must not be used. This period should not exceed 4 weeks. If necessary the label also bears warnings and mentions that the contents should be brought to room temperature before administration if the tube is stored in the refrigerator. 

For each medicine the storage conditimis should be indicated, as well as the shelf life and the beyond-use-date after opening. In this section it is explained how storage times are determined in general. Secondly, a system is introduced that can be used especially for pharmacy preparations. Finally storage conditions are dealt with. 

Check if the beyond use date allows a reasonable usage period for the patient. 

The expiry date of pharmacy preparations depends on the date of preparation, the conditions under which the preparation is made, the type of container and the storage conditions. It should always be part of the label of stock preparations. In practice, it will not always be necessary for the patient to know this expiry date, as long as the beyond-use date lies before the expiry date, and the container is opened shortly after dispensing. Most important for the patient is that the label is clear and unambiguous on the maximum period of storage. 

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