Did You Know? Ophthalmic Medication Beyond-Use Date Guide

Apr 16, 2024 | Clinical Insight

From the Centers for Medicare & Medicaid Services (CMS)

From CMS: §483.45(g) Labeling of Drugs and Biologicals and §483.45(h) Storage of Drugs and Biologicals: “ensure that all drugs and biologicals used in the facility are labeled in accordance with professional standards, including expiration dates.”

It is good standard practice to date an ophthalmic (eye) medication upon opening, as the date should be tracked according to the facility policy to reduce risk of using contaminated products.

Manufacturers provide storage recommendations and stability information in the package labeling or product insert, and must be considered to determine a ‘beyond use date’ or shortened expiration date for the preparation. Other ophthalmic preparations follow the expiration date listed on the bottle or packaging.

If the manufacturer does not provide stability data for once the preparation is opened, current practice guidelines recommend to discard the medication after 28 days due to concerns of stability and sterility.

General best practice techniques for handling and administering ophthalmic preparations:

  • Wash hands prior to administration and apply using examination gloves.
  • If the preparation is a suspension, make sure to shake well.
  • Remove the cap, taking care to avoid touching the dropper tip. Place the cap on the barrier or a clean, dry surface.
  • Never touch the tip of the bottle to the patient’s eyelids, eyelashes, or surface of the eye
  • If more than one preparation is being administered, please ensure that facility policy is being followed regarding the recommended time that should elapse between the use of each medication to allow for proper absorption (typically 5 minutes).
  • If an ophthalmic ointment and eye drop are being administered in the same patient, make sure that the ointment is used last.
  • Keep the bottle tightly closed when not in use to avoid contamination.

To best utilize this list:

  • (1) search for manufacturer of the product, which is alphabetized on the left-hand column, and then
  • (2) search for product name under the listed manufacturer and see corresponding beyond-use date recommendation.
  • The NDCs listed describe the product and not the package size, therefore the last two
  • digits of the NDC are not included.

The following chart lists several ophthalmic medications for which the manufacturer has been contacted to determine the expiration date once the preparation has been opened. This list may not be all inclusive. If a medication is not included in the chart below, package labeling can be found at https://dailymed.nlm.nih.gov/dailymed/ or contact your HealthDirect Pharmacy for assistance.

Ophthalmic Medication Beyond-Use Date Guide (table)

Ophthalmic Medication Beyond-Use Date Guide (table only)

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Joseph Zywicki

Joe is our HealthDirect Spring 2024 intern. A 2024 Doctor of Pharmacy Candidate, with St. John Fisher University of Pharmacy and Health Sciences.

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