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Consultation: Draft Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8
This consultation closed on 23 October 2009.
The National Coordinating Committee on Therapeutic Goods (NCCTG) sought comment from interested parties on a new code of good wholesaling practice for scheduled medicines, to be introduced under state and legislation.
The draft Code was available for review by interested parties.
The current Australian Code of Good Wholesaling Practice for Therapeutic Goods for Human Use was published in 1991. The NCCTG's review of the Code was partly prompted by recommendation 18 of the Final Report of the National Competition Policy Review of Drugs, Poisons and Controlled Substances Legislation (the 'Galbally Review'), which recommended that compliance with a revised Code becomes a condition of licence for wholesalers of medicines regulated by legislation.
Consultation on an early revision of the Code was undertaken in mid 2006 by the Therapeutic Goods Committee (TGC), the committee which advises the Commonwealth Minister for Health on matters relating to standards for therapeutic goods. The draft Code now released for comment takes note of the considerations of the TGC, consultations with the National Pharmaceutical Services Association (NPSA) as the organisation representing the wholesale industry and, because of growing concerns about diversion of pseudoephedrine to illicit use, comments from law enforcement agencies.
The draft Code is intended to apply only to the wholesaling of medicines in Schedules 2, 3, 4 and 8 of the Standard for the Uniform Scheduling of Drugs and Poisons and not to therapeutic goods more broadly. It is also intended to apply to 'manufacturers' as well as 'wholesalers', as supply from manufacturers and sponsors is an activity that comes within the definition of "wholesale" in state and territory legislation.
A key feature of the draft Code is its balance between principles and detail. In particular, in order to deal with the range of sizes and operations of different wholesalers, the draft Code presents a risk management, rather than a prescriptive, approach.
A major issue not adopted in the draft Code is batch tracking. Currently, medicines moving through the supply chain from manufacturer to wholesaler to pharmacy are not tracked by batch number. In the case of a recall, this situation does not permit ready identification of pharmacies and other health services providers who have been supplied with the recalled batch(es) and can affect the efficiency of the recall. At this time, the NCCTG does not consider it feasible to incorporate batch tracking in the Code, but it is expected that it will be included in the future and wholesalers are advised to explore means of undertaking batch tracking as they review their operations.
It is proposed that, in order to be consistent with recommendation 18 of the Galbally Review, compliance with the Code will become a requirement under state and territory legislation, for example, through a condition of licence. It is proposed that once the "Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8" is finalised there will be a twelve month lead time for its requirements to come into effect to enable wholesalers to review operations and make any necessary adjustments to ensure compliance.
NOTE: Implementation and transition arrangements for the new Code, once finalised, are matters for each state and territory to separately determine. This consultation is not seeking comments on transition arrangements, which may vary between jurisdictions.
Comments received in response to this consultation were considered by the NCCTG. See: NCCTG feedback on submissions
Submission of comments
Comments on the draft Code were to be provided by close of business, Friday 23 October 2009.
Submissions will be placed on the TGA's website unless marked 'IN CONFIDENCE'. For submissions made by individuals, all personal details other than your name will be removed from your submission before it is published on the TGA's website. Confidential material should be provided under a separate cover and clearly marked 'IN CONFIDENCE'.
13 October 2010
The NCCTG thanks the organisations that provided comments on the draft 'Australian Code of Good Wholesaling Practice for Medicines in Schedules 2, 3 4 and 8' (7 August 2009).
Submissions received in response to the consultation are published where the organisation providing the submission has agreed.
- Consultation submission: Anspec Pty Ltd (pdf,216kb)
- Consultation submission: Australian Self-Medication Industry Inc (pdf,186kb)
- Consultation submission: Pharmacy Guild of Australia (pdf,40kb)
- Consultation submission: Pharmaceutical Society of Australia (pdf,46kb)
- Consultation submission: Ridley AgriProducts Pty Ltd (pdf,99kb)
Submissions were also received from:
- Alexion Pharmaceuticals Australasia Pty Ltd
- Amgen Australia Pty Ltd
- CSL Limited
- CSO Funding Pool Administration Agency
- National Pharmaceutical Services Association
- Orphan Australia Pty Ltd
- Pharmatel Fresenius Kabi
- Sanofi Aventis Healthcare Pty Limited
NCCTG feedback on submissions
13 October 2010
Submissions were considered by the National Coordinating Committee on Therapeutic Goods (NCCTG). A summary of the major issues raised in the submissions, how the issues are addressed in the final Code, and the NCCTG rationale for the final Code, are included in the table below.
The table should be read in conjunction with the draft Code of August 2009 or the final Code which becomes effective on 1 April 2011.
Amendments to principles
Section 4 - Stock Handling and Stock Control and Section 6 - Management of Complaints, Return of Unused and/or Damaged Goods, and Product Recalls - The Principles are amended so that handling of damaged, returned and recalled medicines is included in Section 6.
Section 7 - Management of Records, Documentation and Standard Operating Procedures - The Principle now includes that documentation should be adequate to achieve the required standard of recording and control for quarantined stock, as Quarantine can to be maintained by computer records (see Section 6.8).
Section 8 - Cold Chain Medicines - The Principle now includes that the cold-chain should accord be maintained according to the sponsor's recommended conditions in regard to product integrity, as set out on the TGA approved product packaging.
|August 2009 draft||2010 final||Rationale|
|Add paragraph on auditing||This information was included as Section 7.15 in the August 2009 draft. Reference to annual audits is removed and replaced with risk-based audits, which could be internal or external as appropriate.|
|Acknowledgments||The NCCTG acknowledges the contribution of stakeholders to the development of the Code.|
|Add or amend definitions of 'cold chain', 'repackaging', 'standard operating procedure' and 'wholesaler'||Clarifications. 'Standard operating procedure' replaces 'procedures' throughout the Code.|
|Section 1 - Buildings and Grounds|
|1.2||No change||NCCTG supports both the reference in Section 1.2 to a physical space for Quarantined stock, and the reference in Section 6.8 to allow Quarantine to be maintained solely by computer records.|
|1.4||1.4||Additional references to bays, docks, etc is based on the 1991 code.|
|1.5||1.5||Addition of need for keeping records of pest control measures.|
|Section 2 - Storage Facilities|
|2.3||2.3||Use of uninterruptible power supply, backup generators or backup refrigeration units are commercial decisions. Sections 8.8 and 8.9 address procedures in the event of failure of temperature control for cold chain medicines.|
|New 2.5 (and subsequent renumbering)||This text largely follows the 1991 code and emphasises the need to consult with the sponsor.|
|Section 3 - Personnel|
|3.4||3.4||Additions to refer to retraining and training audits, and for recording of approval for staff to perform assigned duties and functions.|
|Section 4 - Stock Handling and Stock Control|
|New 4.3 (and subsequent renumbering)||This text is based on the 1991 code.|
|4.4, 4.6||4.5||Sections combined.|
|4.7||4.7||Deletion of the need for 3 months shelf life to remain on the goods, as this is a commercial matter.|
|4.8||4.8||Delete 'reconditioning', which relates to devices, which are no longer covered by this Code. Addition of more information on manufacturing licences/authorities.|
|New 4.12||This text is based on the1991 code.|
|4.12, 4.13, 4.14||6.8, 6.9, 6.3(c)||Handling of damaged,returned and recalled medicines is now included in Section 6.|
|Section 5 - Transport|
|5.2||5.2||This text is based on the 1991 code. Transportation to ensure that medicines are stored below 25°C at all times would require air-conditioned transport. This is not intended. However, customers receiving stock from licensed wholesalers of scheduled medicines are entitled to rely on the wholesaler maintaining the integrity of the cold-chain.|
|Section 6 - Management of Complaints, Return of Unused and/or Damaged Goods, and Product Recalls|
Additional requirement to assess returned goods for tampering or contamination.
Additional statement that unsaleable stock should be quarantined. This may also be covered by commercial arrangements between the sponsor and wholesaler.
|Section 7 - Management of Records, Documentation and Standard Operating Procedures|
|7.4||No change||Computer-based record keeping in relation to Controlled Drugs, where allowed, may be subject to jurisdictional legislative requirements. The licensing authority may require additional documentation and validation, etc, where computer records replace rather than supplement written records (e.g, for movements of Controlled Drugs) or physical segregation (e.g., for Quarantine areas).|
|New 7.11 (and subsequent renumbering)||There should be a system to prevent the inadvertent use of superseded documents.|
|7.15||Introduction||Paragraph on auditing now appears in the Introduction. Reference to annual audits is removed and replaced with risk-based audits, which could be internal or external as appropriate.|
|Section 8 - Cold Chain Medicines|
|8.6||(deleted and subsequent renumbering)||Training is covered in Section 3.|
|8.14||8.13||Temperature-control system should be validated. Customers receiving stock from licensed wholesalers of scheduled medicines are entitled to rely on the wholesaler maintaining the integrity of the cold-chain.|
|8.17||8.16||Additional example to reflect the need to prevent inadvertent freezing of cold-chain medicines.|
|Section 9 - Security Arrangements and Procedures|
|9.6||(deleted and subsequent renumbering)||External security of premises is covered under Section 9.1.|
|9.12||9.11||Theft, loss, suspected tampering or suspicious discrepancies in records should be notified within statutory requirements, otherwise within 7 days.|
|9.15||9.14||Waste containers need to be identified as such, but the identity of the waste medicines inside the waste container should not be disclosed.|
|Section 10 - Additional Measures for Management of Controlled Drugs (CD) and other Goods with High Illicit Value (GHIV)|
|Wholesalers with moderate or high risk||Wholesalers with moderate or high risk||
References to the 2004 Australian Standard have been updated to refer to AS/NZS ISO 31000:2009, Risk management - Principles and guidelines.
External identification of deliveries containing Controlled Drugs conflicts with State and Territory laws.
|Comment on August 2009 draft||NCCTG response|
|There is no reference to batch tracking||The NCCTG does not support the mandating of batch tracking at wholesale level at this time.|
|Education programs should be included||Jurisdictions will determine appropriate education strategies, which will depend on status of the Code in each jurisdiction.|
|Performance monitoring requirement should be included||Jurisdictions will determine appropriate monitoring strategies, which will depend on status of the Code in each jurisdiction.|
|The Code should have legislative status||The current Code is cited in legislation in NSW, ACT, QLD and TAS. Adoption of Code to give adequate effect is a matter for each jurisdiction.|
|Rearrangement or combination of sections / practices; various additional examples; editorial comments.||The Code will be searchable in its electronic format. Inclusion of too many examples can be mistaken as exhaustive coverage of the Principle. Use of 'should' and 'must' has been reviewed.|
|Application to animal feed manufacturers||Adoption of Code to give adequate effect is a matter for each jurisdiction.|
|Impact on small businesses/pharmacies||Adoption of Code to give adequate effect is a matter for each jurisdiction.|
|Code should apply to devices||Jurisdictions, other than Tasmania, do not have legislation to require wholesalers of devices to comply with the 1991 Code.|