Expiry Dates on Prescription Labels

Published: September 21, 2012

Legislative References:

  • Food and Drugs Act (FDA)
  • Food and Drugs Regulation
  • Drug and Pharmacies Regulation Act (DPRA)

Additional references:

College Contact: Pharmacy Practice


Background:

The College is often asked why pharmacies do not add the manufacturer’s expiry date on prescription labels. This date is required by Health Canada to be displayed on a manufacturer’s package: it is a ‘consumer-use-by’ date, and for dispensing purposes pharmacists and practitioners must calculate the prescription’s supply to ensure that, if used as directed, the prescription will be completed prior to the stated expiry date.

In general, pharmacists are obligated, through the DPRA, to monitor the expiry dates of drugs and natural health products, and to remove these from pharmacy stock. While it may be useful for a consumer to know the expiry date related to their dispensed medication, there is no legal obligation for a pharmacist to add the expiry date on a prescription label. The pharmacists’ legal obligation is to ensure that the date the drug is dispensed is recorded on the prescription and on the container in which the drug is dispensed.


Definitions:
Expiration date: Food and Drugs Regulations, Part C (Drugs)

  • “expiration date” means the earlier of:
    • the date, expressed at minimum as a year and month, up to and including which a drug maintains its labeled potency, purity and physical characteristics, and
    • the date, expressed at minimum as a year and month, after which the manufacturer recommends that the drug not be used; (date limite d’utilisation)

For Manufacturers:

  • Comply with GMP and Food and Drugs Regulation
    • Product tested to maintain potency to the documented date on label
    • Product tested under controlled conditions
    • Requirement of the legislation
    • By definition, the products expire at the end of the month unless a date is specified

Food and Drug Regulations
C.01.004. (1) The inner and outer labels of a drug shall show
c) on any panel

  1. the name and address of the manufacturer of the drug,
  2. the lot number of the drug,
  3. adequate directions for use of the drug,
  4. a quantitative list of the medicinal ingredients of the drug by their proper names or, if they have no proper names, by their common names,
  5. the expiration date of the drug, and
  6. in the case of a new drug for extraordinary use in respect of which a notice of compliance has been issued under section C.08.004.01, the following statement, displayed in capital letters and in a legible manner:
    “HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS EXTRAORDINARY USE NEW DRUG FOR [naming purpose] BASED ON LIMITED CLINICAL TESTING IN HUMANS.

Expectations regarding labeling

  • Expiry dates on Rx labels, in general, are not a mandatory requirement and may be requested by patients
  • Expiry dates on Rx labels are a requirement on certain compounded products by policy or guidelines
  • When expiry dates are placed on Rx label, pharmacists are expected to explain relevance of the expiry date

Rationale for Not Using Expiry Dates

  • Misleading to Public: expiry dates on approved drugs are requirement of GMP and FDA for manufacturers
  1. Only valid if product is stored in controlled conditions and unopened
  2. Manufacturers cannot guarantee stability, potency or integrity of the product once the bottle is opened due to exposure to air, humidity, temperature changes, light, human contact. Most obvious examples to use are ophthalmics which expire 30 days after opening or reconstituted antibiotics that expire in 7-14 days after mixing with water.
  3. Gives false sense of security to the patient

Requirements to Comply with Standards

A system or method implemented to ensure expired drugs are not dispensed and that drugs will not expire before the patient completes their normal course of therapy.

The systems or methods are the responsibility of the pharmacist and manager and may vary between pharmacies. The systems should be developed keeping the principles of the standards in mind and not the actual expiry dates.