Hospira extended dating fda

hospira extended dating fda

Can Hospira drugs be used past the expiration date?

The U.S. Food and Drug Administration (FDA) has announced that a selection of the injectable drugs manufactured by Hospira, Inc., a Pfizer company, may be used passed the labeled expiration date to ease the ongoing critical shortage of critical care injectable drugs, including atropine, epinephrine and dextrose.

Why did FDA update the expiration dates on some medications?

This is to update and consolidate the extended use date information posted previously (6/15/17 to present). Due to continued intermittent supply interruptions of critical drugs, FDA is alerting health care professionals and patients of updated dates through which some products may be used beyond the manufacturer’s labeled expiration date.

How does FDA handle expiration dating challenges?

Another way FDA can approach expiration dating challenges is through FDA’s expiration dating extension authority under section 564A (b) of the FD&C Act, which was established by PAHPRA in 2013.

Did Hospira fail to submit field alert reports to the FDA?

The ins pection also revealed that Hospira Inc. failed to submit field alert reports to FDA as required by section 505 (k) of the FD&C Act, 21 U.S.C. 355 (k), 21 CFR 314.81 (b) (1) (new drug applications), and 21 CFR 314.98 (abbreviated new drug applications).

Is it safe to store Hospira products?

For patient safety purposes, these drugs should continue to be stored as directed by their labels. Meanwhile, the FDA also announced that Hospira is voluntarily recalling a number of other products because of sterility concerns, several of which are already in short supply.

Are there any recalls on Hospira products?

ACC News Story. Meanwhile, the FDA also announced that Hospira is voluntarily recalling a number of other products because of sterility concerns, several of which are already in short supply. Among the recalled drugs facing shortages: 8.4 percent sodium bicarbonate injection 50mL vials.

Why did FDA update the expiration dates on some medications?

This is to update and consolidate the extended use date information posted previously (6/15/17 to present). Due to continued intermittent supply interruptions of critical drugs, FDA is alerting health care professionals and patients of updated dates through which some products may be used beyond the manufacturer’s labeled expiration date.

Is it safe to take expired drugs?

The U.S. Food and Drug Administration recommends never taking drugs beyond their expiration date as it is risky with many unknown variables. For example, how your drug is stored before you receive it, chemical make-up, and original manufacturing date can all affect potency of a drug.

What is the FDA guidance for field alert reports (Fars)?

This guidance provides FDA’s current thinking regarding the requirements for submission of field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and outlines FDA’s recommendations for FAR submissions to help improve their consistency and relevancy.

What is a field alert report in pharmacy?

Field Alert Reports. The purpose of field alert reports (FARs) is to quickly identify quality defects in distributed drug products that may present a potential safety threat.

Does Hospira have any reports of adverse effects associated with bacteremia?

To date, Hospira has not received reports of any such adverse events associated with this issue for this lot. BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic preservative.

When do you have to submit a far to FDA?

Within 3 days of discovering significant problems with distributed drug product, holders of approved new drug applications (NDAs) or abbreviated new drug applications (ANDAs) must submit a FAR to FDA to comply with 21 CFR 314.81 (b) (1). What must be reported? Information concerning one or more of the following:

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