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Study samples expiration dating

Of these, only aspirin and amphetamine had deteriorated below generally recognized minimum acceptable potency.One other, phenacetin, showed a concentration of less than 60% when tested in one medication, but 110% in another.Expired sample medications may also be a significant problem.

In this study, 14% of sample medications were expired.Indeed, in a qualitative study of 18 family practice offices, Backer and colleagues described a wide variety of sample closet organization systems from “an extraordinary and meticulously organized shelving system,” to a closet that was an “overfilled, disorganized stack of shelves,” where “staff spent vast amounts of time searching for the appropriate sample.” Maintaining sample inventories according to accreditation body regulations requires significant staff or physician effort.Regardless of cause, expired samples are not useful to patients and are a waste of resources.We hypothesize that there are 2 main reasons sample closets contain substantial numbers of expired medications.First, the presence of expired medications may be because of the absence of a reliable inventory system in most practices.The clinics were diverse; we inventoried the closets of 7 family medicine offices and 3 general internal medicine offices; of the 10, 6 were group practices, 4 were solo practices, and 5 were hospital-affiliated and 5 were private practices. We obtained informed consent from each office, and the University of Arizona institutional review board exempted our study from review.We recorded the drug name, quantity, dosage, and expiration date of all sample medications in each closet.In order to be eligible for the extended approval period, the research must present no more than minimal risk to human subjects as determined by the convened IRB or through an expedited review mechanism, and must not include any of the following: Expiration dates are maintained as the date assigned upon initial or continuing review (not at the time of a modification).If during the course of the three year approval period, changes occur that affect the eligibility of the study to continue with an extended approval, the study will immediately become subject to annual review.The IRB reserves the right to make exceptions to this policy, and inclusion/exclusion of any research project under this procedure will be at the IRB’s discretion.During the extended approval period, principal investigators retain responsibility for all regulatory requirements including submission of modifications, reportable events, suspension and/or terminations.

Comments Study samples expiration dating

  • Stability Requirements For OTC Drug Products in the USA.

    Oct 26, 2017. All over-the-counter OTC and prescription Rx drug products distributed within the USA are required to display an expiration date that is supported by stability studies which have been conducted in accordance with current FDA and ICH Guidelines. Each strength of a drug product, and each primary.…

  • Calculation of Approval and Expiration Dates Institutional Review.

    Calculation of Expiration Date. Initial Approval. The IRB calculates the date of expiration in the following manner When a research study is fully approved at a convened meeting, the date of expiration is based on the date of the convened meeting minus one day. For example, if the committee meeting date is 10/17/10, then.…

  • Determination of Product Shelf Life and Establishment of Expiration.

    And how expiration dates are selected and defended. Stability studies may include a number of different types of physical, chemical and microbiological tests, with the focus in the case. For ERA single-use TOC products 30-60 mL, we use the following product example to illustrate the determination of stability date.…