Unit-dose Packaging. Linda F. The unit-dose packaged medication system has been available since the s; however, it has become a standard of practice for health-systems in the U. Patients are charged for only the medications that they actually receive and not charged for an entire bulk bottle. Each dose can be barcoded to allow for new technologies, such as patient bedside scanning and electronic chart documentation.
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 exceptions, 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.
and oral liquids are prescribed much more frequently in children than adults, several key references regarding medication errors in pediatrics are cited.9,10,11,12,13 And because this White Paper focuses on oral liquids, several key references regarding the preparation and dispensing of oral liquids are cited,15,16, May 28, The beyond- use date takes into account various factors, such as the conditions under which the medication may be stored in the patient's home, the . COMPLIANCE POLICY GUIDE (CPG) CPG Sec. Expiration Dating of Unit Dose Repackaged Drugs March
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:. Beyond use dates are different from expiration dates.
Expiration dates are required on commercially manufactured products and are determined after extensive study of the product's stability. Most expiration dates are given in years for commercial products.
Beyond use dates are used for compounded preparations and are generally in days or months. The major problem for pharmacists is that the stability of compounded formulations often is not known. Also, Many instabilities cannot be detected without the use of analytic equipment.
This is in contrast to incompatibilities that can be visually observed. It is not possible to use a manufacturer's expiration date and extrapolate or estimate a beyond use date for a compounded formulation.
The compounded formulation probably will not be identical to the manufactured product; it may have a different drug concentration, use different diluents, be a different fill volume, and be packaged in a different container type.
Extending Beyond Use Dates for Compounded Preparations
When an official monograph isn't present, a systematic approach to assigning the date can be as follows:. Step 1.
Beyond-use dating for repackaged oral liquids can be a challenge. Although the USP has guidelines for assigning BUDs, it can often depend on the oral liquid base. When available, use the information from the manufacturer or from published stability studies to assign BUDs. Oral liquids containing alcohol often have to be given shorter BUDs.
Beyond use dates should be in accordance with the manufacturer's approved labeling. This means that the product was formulated according to the manufacturer's directions, or that the formulation contains the same concentration of drug, in the same diluent, in the same packaging, for the same intended period of use, and so on.
A draft guidance on the compounding and repackaging of radiopharmaceuticals by state-licensed nuclear pharmacies was released in December.
Footnote 13 in the January 12 guidance on drug product repackaging by pharmacies suggests that the agency may develop a version specific to hospitals and health systems. The footnote reads as follows: "FDA is considering the applicability of the policies described in this guidance to hospitals and health systems and intends to address these issues in separate guidance.
Schulte described ASHP as "cautiously optimistic" that FDA will release repackaging guidance specific to the hospital and health-system settings. Further, she said, ASHP will work to ensure that such guidance, if developed and finalized, harmonizes with the competing requirements of the USP chapters and the Centers for Medicare and Medicaid Services.
Mar 10, Take, for example, the beyond-use date (BUD) for tablets taken from a manufacturer's large container and repackaged into smaller containers. According to the guidance, FDA wants the BUD for those repackaged tablets to be the earliest of. 6 months . USP Compounding Standards and Beyond-Use Dates (BUDs) ' The table below summarizes and compares the storage periods and the BUDs in the official chapter and the revised chapter. *CRT (controlled room temperature) One of the most significant changes to the chapter is the inability to extend BUDs beyond those in TableFile Size: KB. When this is not possible, a pharmacist ideally consults with the manufacturer to establish a beyond use date. The USP/NF Section. > Sterile Drug Products for Home Use, Storage and Beyond Use Dating directs that: Most pharmacies have the name, address, and phone number of the pharmacy pre-printed on their prescription labels. In addition.
His membership on that subcommittee and the overarching Compounding Expert Committee ended in FDA defines in-use time for a compounded sterile liquid drug product as the maximum allowable interval from penetration of the container or closure system to the start of administration to the patient. The January 12 repackaging guidance advises pharmacies to take into account the in-use time stated in an FDA-approved drug product's labeling when assigning a BUD to a repackaged sterile drug product.
U.S. Food and Drug Administration New Hampshire Avenue Silver Spring, MD INFO-FDA Contact FDA. Beyond Use versus Expiration Date Expiration date - scientifically determined Beyond use date - for prescriptions or repackaged drug (the date after which a dispensed product should no longer be used by a patient) Repackaging non-sterile oral and liquid dosage forms packaged in unit -dose containers. Water Containing Oral Formulations: no longer than 14 days or the earliest expiration date of any ingredient used, whichever is shorter, and stored at controlled cold temperatures. This includes water being added as an ingredient or water is a component of any ingredient used. For example, diphenhydramine syrup has water as a component.
If the labeling does not specify an in-use time or if the sterile drug product being repackaged is an unapproved product on FDA's drug shortages list, the guidance advises pharmacies to assign a BUD according to the standards in the proposed revision of USP chapter or the expiration date on the original container, whichever results in the shortest time frame. Potassium chloride injection has been on FDA's drug shortages list for nearly 5 years.