Exemption from storage requirements for goods requiring refrigeration

A new exemption is now in force exempting the pharmacist in charge of a pharmacy from the storage requirements of clause 73(1) and clause 76 of the Poisons and Therapeutic Goods Regulation 2008, where the pharmacy is a hospital pharmacy or a retail pharmacy.

This exemption applies to storage of any drug of addiction requiring refrigeration at the following pharmacies:

  1. Retail pharmacy, meaning premises included in the NSW Register of Pharmacies kept under Schedule 5F of the Health Practitioner Regulation National Law (NSW) (including community pharmacies located on the grounds of a private hospital)
  2. Pharmacy in a public hospital within the meaning of the Health Services Act 1997
  3. Pharmacy in a private hospital that is approved by the Federal Minister for Health to supply pharmaceutical benefits to patients receiving treatment in or at the hospital, under section 94 of the National Health Act 1953.

The conditions to this exemption are as follows:

  • The drug of addiction must be stored in a refrigerator which is in a room or enclosure to which the public does not have access.
  • The refrigerator must be:
    • securely attached to a part of the premises, and kept securely locked when not in immediate use, or
    • kept in a separate room, cupboard, or other receptacle, securely attached to a part of the premises and kept securely locked when not in immediate use.
  • Any key or other device by means of which the refrigerator, or room, cupboard or other receptacle in which the refrigerator is kept, may be unlocked:
    • is kept on the person of a pharmacist whenever it is on the same premises as the refrigerator, and is removed from the premises whenever there is no pharmacist at those premises, or
    • is kept in a separately locked safe to which only a pharmacist has access.
  • Any code or combination that is required to unlock the refrigerator, safe, room, cupboard or other receptacle in which the refrigerator is kept, is not divulged to any unauthorised person.
  • The drug of addiction, or any other drug including restricted substances or poisons requiring refrigeration stored in the refrigerator with the drug of addiction, must only be accessed by a pharmacist.
  • The drug of addiction, or any other drug including restricted substances or poisons requiring refrigeration stored in the refrigerator with the drug of addiction, must be stored apart from food or any other goods.

The Gazetted notice can be found on page 81 here.