During our recent EASR webinar, a question was raised regarding waste exemptions applicable to community pharmacies, particularly in relation to the acceptance of date-expired medicines and the operation of needle exchange services.
This article aims to clarify the regulatory framework and provide guidance on relevant exemptions and requirements.
Waste Exemptions and Community Pharmacies
One of the key concerns discussed was Paragraph 39, which previously allowed community pharmacies to accept date-expired medicines and operate needle exchange services.
This exemption has now been superseded by Waste GBR3 – Storage at a Collection Point, as outlined by SEPA.
Waste GBR3 – Storage at a Collection Point
This General Binding Rule (GBR) permits the temporary storage of waste at a collection point, including:
- Out-of-date medicines
- Waste from needle exchange programs
Importantly:
- No notification to SEPA is required under GBR3.
- This activity is considered low risk, but SEPA must be informed if the activity falls outside the scope of GBR3.
You can find more details on GBR3 here: https://www.sepa.org.uk