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Expiration dating of unit dose repackaged drugs

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Added: 12.08.2019
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Sayeed, Ph. Each single-unit or unit-dose container bears a separate label, unless the device holding the unit-dose form does not allow for the removal or separation of the intact single-unit or unit-dose container therefrom. Since its adoption in , the CPG has stated that, in light of the USP standards and under certain conditions, the agency does not deem it necessary that stability studies be conducted on drugs that are repackaged into unit-dose containers. You must accept the terms and conditions. Find a Lawyer.

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U.S. Food and Drug Administration

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Expiration Dates for Solid Oral Drugs: FDA Revises Draft Guidance | RAPS

Comment title. US Federal Law. FDA believes that undercertain specified conditions, it may be possible to assign appropriate expiration datingwithout conducting new stability studies on the nonsterile solid and liquid oral dosageforms repackaged into unit-dose containers. Enhanced Content - Developer Tools. 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. Since most drug products are repackaged at the time of dispensing by a pharmacist, unless they are readily available in unit-of-use form from the manufacturer, it is imperative to consider the stability of these products once they are opened and repackaged in a different container closure system. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
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FDA Guidance for Industry: Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products

While the potency of the repackaged tablets remained within the acceptable range i. Stability of gabapentin mg capsules repackaged in unit-dose containers. Do not repackage a product with labeling that cautions against repacking. We originally issued CPG b. These ICH and FDA recommendations provide reasonable assurance that a drug product will maintain its physical and chemical characteristics and potency during the approved shelf life as long as it is retained in the original container closure system and stored under the same conditions defined in the product labeling.
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Where no humidity is specified in the labeling of the original drug product, therelative humidity should not exceed 75 percent at 23 degrees Celsius for the repackagingand storage of solid oral dosage forms. Expiration and beyond-use dating. The stability of reconstituted amoxicillin—clavulanate oral suspension in the original containers versus unit dose oral syringes was studied by Tu and colleagues.
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