MEDICAL NITROUS OXIDE AND ENTONOX COMPLIANCE

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Alyson Sharp
6 years ago
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1 Thursday 15 th April 2010 Dear Agent, MEDICAL NITROUS OXIDE AND ENTONOX COMPLIANCE Medical Nitrous Oxide and Entonox are Schedule 4 - Restricted Substances in accordance with the Federal Medicines Act for Scheduled Drugs and corresponding State Acts and Regulations. Nitrous Oxide is a substance that may be subject to abuse by individuals and that abuse is often fatal. As such they: Are governed by local State/Territory legislation Must only be sold in accordance with the conditions and requirements of the relevant Drugs & Poisons Regulations Must be stored in accordance with the requirements of state Drugs & Poisons Regulations As a BOC Gas Agent, there are strict requirements and guidelines for you to follow when storing and/or supplying Medical Nitrous Oxide and/or Entonox to customers. This communication outlines the legal requirements you must comply with in order to store and sell BOC Schedule 4 products State Wholesale Licencing Requirements An Overview. Storing Schedule 4 Products What is required from you as a Gas Agent. Selling Schedule 4 products What is required from the customer and you as a Gas Agent. Non Conformance What a Gas Agent needs to know. State specific order requirements What you need to know for your State. Step by Step Guide Supplying Medical Nitrous Oxide/Entonox to a customer. Appendix 1 Medical Nitrous Oxide/Entonox Loading Form (Available on PartnerNET) Appendix 2 Medical Nitrous Oxide/Entonox Purchase Order Form (Available on PartnerNET) Should you have any questions or concerns about this communication, please contact s on This communication will also be available on PartnerNET, under the GAS LICENCING link on the home page. Regards, s.

2 State Wholesale Licensing The premises from which Medical Nitrous Oxide and Entonox is being sold and/or stored must be licensed in accordance with the relevant State and Territory Drugs and Poisons Regulations. It is illegal to sell, procure or be in possession of Schedule 4 products, such as Medical Nitrous Oxide and Entonox, without a current wholesale licence. These licences: Apply only to the physical address stated on the licence Are non-transferable The licence certificate must be displayed in a prominent position at the licensed premises. Western Australian (WA) premises are not required to be licensed but are required to meet all other regulatory requirements for security, storage, sales to authorised persons and record keeping, reporting non-conformances and lost/missing cylinders. In order to safely supply Medical Nitrous Oxide and Entonox and to prevent its misuse, the licensee to wholesale these gases, has an obligation to ensure that the customers they supply are authorised to obtain or be in possession of these gases. Storing Schedule 4 Products What is required from you as a Gas Agent? sell Medical Nitrous Oxide and Entonox from licensed premises only ensure that the licence certificate is displayed on those premises ensure that only customers authorised to receive Schedule 4 products do so ensure the products are stored in a separate locked area, that has no public access ensure stock compliance is performed on a regular basis report any lost or missing/stolen Nitrous Oxide or Entonox products to the QRA Regulatory Affairs Manager by contacting s. Notify BOC if changes are made to: Trading name, change of premises, change of responsible person named on the license. Gas Agents are responsible for ensuring that any of their staff who sell and handle Medical Nitrous Oxide and Entonox are trained in the relevant procedures. Gas Agents must ensure that records are securely kept. Purchase Orders must have the PartnerNET sales order number reference and be filed locally as these must be available to Health Inspectors if requested. State Health inspectors will usually audit premises that have applied for a license or prior to license renewal applications being accepted. They also may audit any licensed or non-licensed premises without warning. All Agents must co-operate with auditors and provide inspectors with any requested records.

3 Selling Schedule 4 Products What is required from the customer and you as a Gas Agent? The following people are authorised to order Medical Nitrous Oxide and Entonox in Australia: registered medical practitioners registered dentists registered pharmacists registered veterinary surgeons. Other business types require specific authorities in order to purchase Schedule 4 products. The customer is required to complete the Medical Nitrous Oxide and Entonox Loading Form (Appendix 1) and fax/ to s for customer verification. Authority to order requirements vary from State to State. If an order for Medical Nitrous Oxide and Entonox cannot be placed on a customers account in PartnerNET this means the customer has not been verified as an authorised customer or a purchase order is required. These customers must be verified, authorised and have the block in PartnerNET lifted before an order can be placed. (See - Step by Step Guide Supplying Medical Nitrous Oxide/Entonox to a customer) Non-Conformance What a Gas Agent needs to know! Listed below are examples of non-conformance with regards to the supply of Medical Nitrous Oxide and Entonox: supply to unauthorised customers without prior confirmation of customer s account authority details supply from unlicensed premises not displaying a certificate of your Gas Agent licence at the premises incorrect storage arrangements allowing for unlawful access to Medical Nitrous Oxide and Entonox failure to retain transaction details. failure to report missing/stolen Nitrous Oxide or Entonox cylinders Non-conformance may incur monetary penalties by State Health Authorities. For customers that do not have a purchase order system must complete the Medical Nitrous Oxide/Entonox Purchase Order form (Appendix 2). Customers who need to have the exclusion lifted must complete the Medical Nitrous Oxide/Entonox Loading form (Appendix 1).

4 State specific order requirements What you need to know for your State. QLD and NT Customers purchasing Nitrous Oxide or Entonox in Queensland and Northern Territory must provide a written and signed Purchase order. The customer must provide the following details in the Purchase order for every order that is placed: A purchase order number The date of order The full name, title and address of the authorised person The name and quantity of the product The signature of the authorised person Name of the person ordering the product (if not the authorised person) If a customer does not have a Purchase Order form of their own, use the Medical Nitrous Oxide/Entonox Purchase Order form (Appendix 2). It is BOC policy to request written and signed Purchase Orders from all customers in Queensland and Northern Terrirtory. File and store all written Purchase Orders at your Gas Agency premises. NSW, VIC, WA, TAS ACT and SA Customers purchasing Medical Nitrous Oxide or Entonox in New South Wales, Victoria, Western Australia, Tasmania, Australian Capital Territory and South Australia can place orders over the phone or by fax. The customer must provide the following details in the order: The full name, title and address of the authorised person The date of order Name and quantity of the product Full name of the person placing the order (if not the authorised person)

5 Step by Step Guide Supplying Medical Nitrous Oxide/Entonox to a customer. STEP 1 - Customer wishes to purchase Medical Nitrous Oxide and Entonox through your Gas Agency. STEP 2a - QLD/NT only Is the PO signed by the authorised person? If YES, continue to Step 3 If NO, do not supply STEP 2b - WA/NSW/VIC/SA/TAS only Has the customer supplied you with details of the authorised person? If YES, continue to Step 3 If NO, do not supply Step 3 You will need to confirm who the authorised person is by contacting s. Step 4 Once confirmed by s, you can put the order through PartnerNET and supply gas to customer. Step 5 Retain the PO form at your Gas Agency for auditing purposes. Frequently asked Questions - Supplying Medical Nitrous Oxide/Entonox to a customer. How does a customer become authorised to purchase a Schedule 4 product? - The customer must complete the Medical Nitrous Oxide/Entonox Loading Form (Appendix 1) What if a QLD/NT customer does not have a Purchase Order? - Ask the customer to complete the Medical Nitrous Oxide/Entonox PO Form (Appendix 2). This PO form must be completed and signed by the authorised person. If you are supplying to a hospital, the authorised person is ALWAYS the pharmacist. If in doubt about a customers integrity, DO NOT SELL the product. Contact s immediately on

6 APPENDIX 1

7 APPENDIX 2

MEDICINES CONTROL COUNCIL

Licence to act as a Wholesaler or Distributor MEDICINES CONTROL COUNCIL GUIDELINES FOR LICENCE TO ACT AS A WHOLESALER or DISTRIBUTOR This guideline is intended to provide recommendations to applicants