scheduled substance management plan
TRANSCRIPT
Scheduled Substance Management Plan Plan Commencement
date
31/07/2016
Approving authority University Biosafety Committee
Advisor Scott Burnell
Next scheduled review 2021
Document URL
Sharepoint document
Description This document outlines the plan for managing risks associated with Griffith
University staff or students preforming regulated activities in relation to
scheduled substances (Medicines, Poisons and Therapeutic Goods).
UBC Chair Approval
Signature
22/04/2016 Prof Ned Pankhurst
Related documents
Work Health and Safety Act 2011
Griffith University Health and Safety Policy
Queensland Health Act 1937
Queensland (Drugs and Poisons) Regulation 1996
Queensland Health Medicines, Poisons and Therapeutic Goods Act 2015 (Draft)
Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)
Therapeutic Goods Act 1989
Therapeutic Goods Administration (TGA) scheduling of medicines & poisons
1.0 INTRODUCTION ....................................................................................................................... 2 2.0 APPLICABILITY ........................................................................................................................ 2
2.1 Scope ................................................................................................................................ 2 2.2 Exclusions ......................................................................................................................... 2
3.0 DEFINITIONS ............................................................................................................................ 3 4.0 GOVERNANCE ......................................................................................................................... 5
4.1 Governance Roles ............................................................................................................. 5 A. University Biosafety Committee Chair ................................................................................ 5 B. University Biosafety Committee (UBC) .............................................................................. 5 C. University Scheduled Substances Manager ....................................................................... 5 D. Drugs Officer ..................................................................................................................... 5 E. Eligible persons ................................................................................................................. 5 4.2 Risk Management .............................................................................................................. 6 4.3 Information Communication and Training .......................................................................... 6 4.4 Approved Locations ........................................................................................................... 6
5.0 ENDORSEMENT REQUIREMENTS .......................................................................................... 6 6.0 OBTAINING AN APPROVAL .................................................................................................... 7
6.1 Approval process for research or teaching purposes ......................................................... 8 6.2 Conditions of Approval....................................................................................................... 8 6.3 Drugs Officer Conditions .................................................................................................... 8 6.4 Procurement ...................................................................................................................... 8 6.5 Arrival at a Controlled Delivery Point ................................................................................. 8
7.0 POSSESSION RESPONSIBILITIES .......................................................................................... 9 7.1 Records ............................................................................................................................. 9 7.2 Disposal ............................................................................................................................ 9 7.3 Labelling ............................................................................................................................ 9 7.4 Storage ............................................................................................................................ 10 7.5 Restricted Access ............................................................................................................ 10 7.6 Inventory Control ............................................................................................................. 10 7.7 Unaccounted Drugs and Incident Reporting .................................................................... 10 7.8 Transport ......................................................................................................................... 10
8.0 Appendix 1: Simplified Process Flow Chart ........................................................................ 11 9.0 Appendix 2: Example Regulated/Controlled Drugs and Poisons Log .............................. 12
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1.0 INTRODUCTION
Currently the use of Drugs and Poisons is regulated under the Health (Drugs and Poisons) Regulation 1996;
under the Health Act 1937, however this will be replaced by the proposed Medicines, Poisons and
Therapeutic Goods Act in 2017. The new Act will offer consistency with other States and National
Regulation, to ensure proper access, proper use, the proper product and the proper person in relation to
medicines, poisons and therapeutic substances. Under the Act an entity undertaking activities involving
regulated substances must have a Scheduled Substance Management Plan (SSMP). The SSMP must
outline the organisation’s processes for the procurement, storage, handling, record-keeping, stock keeping
and disposal of medicines and poisons to ensure safety, security and quality.
Specifically the SSMP must specify the University’s procedures for medicines and poisons to ensure:
individuals have the necessary qualifications, expertise and authority to undertake a regulated activity involving scheduled substances.
compliance with the plan is monitored, including reporting, investigation and follow-up of any adverse events associated with the quality, safety and security of a substance.
authorisation, authentication and non-repudiation of instruction to supply or administer a medicine or poison.
authorised purchase of a substance from a source external to the licensee, business or entity to minimise the risk of a substance being obtained for illicit purposes.
restricted access to storage facilities, including measures to be taken to prevent unauthorised access to a storage facility.
control inventory and reconciliation processes to prevent, detect and/or deter unauthorised access that could result in a substance or relevant records being lost, stolen, misplaced or misused.
substances are disposed of, or destroyed in order to prevent accumulation, unauthorised access or public harm.
the safe and secure transport, holding and delivery of substances by managing the chain of custody in order to prevent them from being lost, stolen, misplaced or misused.
Note: The Schedule to which a medicine or poison is assigned can also be identified using ChemWatch GoldFFX®.
2.0 APPLICABILITY
2.1 Scope
The SSMP applies to medicine and poison transactions involving:
research activities;
learning and teaching activities;
formal agreements between the University and external organisations when the University
occupies a building and is responsible for the management of the facility e.g. a remote
clinic;
Any other activity directly controlled by Griffith University.
2.2 Exclusions
This plan does not cover medicines, poisons and therapeutic substances in the following
circumstances:
used within the scope of responsibilities allocated to the University Health Services or GP
clinics;
under the control of individuals for personal needs, e.g. adrenaline to treat anaphylaxis;
used and controlled by other commercial entities located on campus e.g. a Commercial
pharmacy.
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3.0 DEFINITIONS
Appropriately Qualified: for an Officer of the University, refers to someone having the qualifications,
experience or standing appropriate to the exercise of the power. A person assigned the following
positions would be nominated by the Head of Element and confirmed by the appropriate senior
manager such as Group PVC:
Drugs Officer;
Senior Research Academic;
Technical Managers;
University Scheduled Substance Manager;
Manager – University Safety Team; and
Health & Safety Adviser (Chemicals & Radiation), University Safety Team.
Authority: Means the power to make decisions and/or enforce conditions a person has under the Regulation. Applicant: refers to the person applying for approval under section 18(1) of the Regulation. This person is usually an academic or research staff member.
Drugs Officer: a person authorised by a Group or Element to monitor the use and storage of scheduled substances and the person who applies for an endorsementon behalf of an Applicant.
Eligible Person: person required to perform regulated activities in the course of their occupation or engagement. Also includes persons registered or those undergoing training to become a registered health professional or veterinary surgeon.
Emerging Substance: a substance not previously listed under the SSMP which is declared as a scheduled substance by the government.
Endorsement: an authority, approval, certification, drug licence or permit.
Endorsement Holder: person whose name appears on an endorsement.
Medicine: a Scheduled substance in the category of an S2, S3 or S4 medicine.
Monitored Substance: an S8 Medicine or substance prescribed by Regulation to be a monitored substance.
Poison: a Scheduled substance in the category of an S5, S6 or S7 poison.
Possess: having custody or control of, and the ability or right to obtain custody or control of the drug, poison or other substance.
Prohibited Substance: a Scheduled substance in the category of an S9 or S10/Appendix C prohibited substance.
Regulated Activity: a person performs a regulated activity for a Scheduled substance if they possess, manufacture, supply, administer, apply the substance or directs or authorises another person to perform any of these activities.
Restricted Medicine: an S4 or S8 Medicine, listed in the Poisons Standard or prescribed by Regulation.
Relevant Occupation: occupation such as dentist, doctor, indigenous health worker, midwife, optometrist, podiatrist, registered nurse or veterinary surgeon.
Scheduled Substance: substances declared as an emerging substance, in the Poisons Standard
and those listed in the current SUSMP including:
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Schedule 2: Pharmacy Medicine: Substances, the safe use of which may require advice from
a pharmacist and which should be available from a pharmacy or, where a
pharmacy service is not available, from a licensed person.
Schedule 3: Pharmacist Only Medicine: Substances, the safe use of which requires
professional advice but which may be available to the public from a pharmacist
without a prescription.
Schedule 4: Prescription Only Medicine or Prescription Animal Remedy: Substances, the
use or supply of which should be by or on the order of persons permitted by State
or Territory legislation to prescribe and should be available from a pharmacist on
prescription.
Schedule 5: Caution: Substances with a low potential for causing harm, the extent of which
can be reduced through the use of appropriate packaging with simple warnings
and safety directions on the label.
Schedule 6: Poison: Substances with a moderate potential for causing harm, the extent of
which can be reduced through the use of distinctive packaging with strong
warnings and safety directions on the label.
Schedule 7: Dangerous Poison: Substances with a high potential for causing harm at low
exposure and which require special precautions during manufacture, handling or
use. These poisons should be available only to specialised or authorised users
who have the skills necessary to handle them safely. Special Regulations
restricting their availability, possession, storage or use may apply.
Schedule 8: Controlled Drug: Substances that should be available for use but require
restriction of manufacture, supply, distribution, possession and use to reduce
abuse, misuse and physical or psychological dependence.
Schedule 9: Prohibited Substance: Substances which may be abused or misused, the
manufacture, possession, sale or use of which should be prohibited by law except
when required for medical or scientific research, or for analytical, teaching or
training purposes with approval of Commonwealth and/or State or Territory Health
Authorities. Schedule 10: Substances prohibited for sale, supply and use: Substances of such danger to
health as to warrant prohibition of sale, supply and use (formerly Appendix C). In Queensland, Schedule 10 substances include many common chemicals that have been prohibited for use in particular circumstances such as human therapeutic or domestic use.
Supply: for a Scheduled substance, means to sell, dispense, give a treatment dose/s, or dispose of
the substance as waste.
Transaction: An event by which – A controlled drug, restricted drug or poison comes into or goes out
of a person’s possession; or the composition, form or strength of, or way of packing, a controlled or
restricted drug or poison is changed; for example: moving a controlled or restricted drug or a poison
from one place to another (with or without a change of ownership).
University Scheduled Substances Manager: a person endorsed by the UBC to provide advice and
support to the University’s Drugs Officers and other eligible persons; maintain centralised records of
endorsements; and facilitates incident investigations and periodic audits.
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4.0 GOVERNANCE
4.1 Governance Roles
A. University Biosafety Committee Chair
The University Biosafety Committee chair will be the person responsible for authorising the SSMP and ensuring the plan is implemented and reviewed.
B. University Biosafety Committee (UBC)
At Griffith University the establishment, communication, monitoring and review of the SSMP will be overseen by the University Biosafety Committee (UBC). The UBC will take reasonable steps to:
inform all employees and other persons required to comply with and about the contents of this plan.
ensure that employees and other persons required to comply with the plan do so; and
ensure that the plan is monitored and reviewed, including after significant changes to activities or at least every five years after the commencement of the plan.
The effectiveness of the SSMP will be monitored by the Committee in conjunction with the University Scheduled Substances Manager and other relevant persons using records, audits, inspections and incident reports.
C. University Scheduled Substances Manager (USSM)
A member of the University Health and Safety Team will be authorised as the University Scheduled Substances Manager by the Chair of the UBC. As part of the authorisation process this role will be subject to a criminal history check. This role will provide advice and support to the University Drugs Officers and other eligible persons; maintain centralised records of endorsements and facilitate periodic audits. The University Scheduled Substances Manager can also be invited by special approvers to further approve the acquisition of scheduled substances as required. In addition, the role will assist the UBC in the reporting, investigation and follow-up of any adverse events relating to the quality, safety and security of substances.
D. Drugs Officer
Groups and Elements may elect to authorise an appropriate person(s) to act as a Drugs Officer(s). As part of the authorisation process a criminal history check should be undertaken by the Element. The role of a Drugs Officer will be to coordinate the acquisition of endorsements for eligible persons, coordinate the acquisition of substances and confirm that individuals having access to or carrying out a regulated activity have the necessary qualifications, expertise and authority to undertake these tasks. The role will also be required to confirm that all procedures for the secure storage, dispensing, use, disposal and records of scheduled substances are in place and adhered to by all eligible persons within their Element, Institute or Group.
E. Eligible persons
An eligible person will be required to have provided evidence of their qualifications, expertise
and training to the University before approval to obtain, possess or utilise a scheduled
substance can be obtained. Eligible persons will also be required to complete all relevant online
training modules but would not normally be subject to a criminal history check.
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4.2 Risk Management
This SSMP aims to ensure that controls are in place to manage the risks associated with scheduled substances and regulated activities at the University. These risks include:
Intentional or accidental misuse;
Theft, diversion or other loss;
Incorrect labelling, expiry or other substance quality issue that may affect persons or animals;
Incorrect disposal, spillage or release; and
Non-compliance with State or Federal legislation.
4.3 Information Communication and Training
Information on this SSMP, including notification of changes will be provided to persons to whom this plan applies via dissemination through Groups and Elements by the UBC, Health and Safety Committees and the University Schedules Substance Manager. The SSMP will also be available on the web through the staff portal. Awareness training will also be included in online laboratory safety modules and incorporated into laboratory inductions. Further training and instruction will be provided by the University Scheduled Substance Manager as required.
4.4 Approved Locations
Scheduled substances may be used and securely stored within University facilities at the Nathan, Gold Coast, Mt Gravatt, South Bank and Logan campuses. Scheduled substances may also be used and stored in secure locations controlled by Griffith University off campus, such as in remote clinics.
5.0 ENDORSEMENT REQUIREMENTS
In order to obtain, possess, manufacture or utilise a Scheduled substance and depending on the
Schedule of the substance, it may be a requirement to obtain an authority, approval, certification, a
drug licence or a permit. Approval must be obtained from the University Scheduled Substance
Manager before applying to Qld Health for a licence, permit or authority to possess a drug or poison.
In addition, if a substance is a regulated restricted drug (RRD) then endorsement from Qld Health is
also required. Please note that under this plan all existing stocks of Drugs and Poisons subject to
endorsement must be registered with the University Scheduled Substance Manager.
Schedule 2 (Pharmacy Medicine), Schedule 3 (Pharmacist Only Medicine) and Schedule 4
(Prescription Only Medicine or Prescription Animal Remedy)
Endorsement is required.
Approval to obtain, possess or give S2, S3 and S4 substances must first be received by the
University Scheduled Substance Manager who will advise if additional endorsements are
required from Qld Health. Under the current Regulation the Vice Chancellor has the authority to
obtain, possess or give S2, S3 and S4 substances, (except those listed as regulated restricted
drugs). This authority can be delegated by the Vice Chancellor to an appropriately qualified
Officer of the University, i.e. to the University Scheduled Substance Manager, Drugs Officer or
applicant. Under the proposed legislation it is expected that Qld Health may issue a University
approval to the Vice Chancellor for a specific range of activities such as clinical teaching
(animal and human), laboratory research, laboratory teaching, pest animal eradication (for
some organisations), and animal management and welfare. Depending on the scope of the
approval provided additional endorsements may be required for some S2, S3 and S4
substances used within a university.
Under the Regulation, trainees in certain occupations (whilst under the supervision of an
authorised person carrying out the relevant occupation such as a dentist, doctor or registered
nurse) are also authorised to possess and administer S2, S3 or S4 substances (except those
listed as regulated restricted drugs).
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Endorsement for the possession and use of regulated restricted drugs must be obtained from
QLD Health.
Schedule 5 (Caution) and Schedule 6 (Poison)
No endorsement is required.
Schedule 7 (Dangerous Poison)
Endorsement is required for the possession and use of poisons listed as regulated poisons in
the Regulation. Endorsement is not required for all other poisons when used for analytical and
research purposes.
Schedule 8 (Controlled Drug)
Endorsement is required.
Endorsement must be obtained from the delegate of the Chief Executive, Queensland Health
for the possession and use of S8 (controlled drugs) Companies supplying S8 drugs will require
the endorsement to be provided to them before the drug can be ordered.
Note: Endorsement for controlled drugs may not be required for clinical trials that are approved
either by a human research ethics committee (registered by the Australian Health & Ethics
Committee) or the Therapeutic Goods Administration.
Schedule 9 (Prohibited substance)
Endorsement is required.
These substances are prohibited except when required for medical or scientific research or for
analytical, teaching or training purposes. Endorsement must be obtained from the delegate of
the Chief Executive, Queensland Health for the possession and use of Schedule 9 substances.
Schedule 10 (Substances prohibited for sale, supply and use) Endorsement is required. These substances are of such danger to health as to warrant prohibition of sale, supply and use (formerly Appendix C). In Queensland, Schedule 10 substances include many common chemicals that have been prohibited for use in particular circumstances such as human therapeutic or domestic use.
Note:
Refer to Attachment 1 for flow chart of endorsement requirements.
For definitions of the schedules refer to: Standard for the Uniform Scheduling of Medicines and
Poisons (SUSMP).
For further information consult with the University Scheduled Substance Manager.
6.0 OBTAINING AN APPROVAL
The approval process for scheduled substances varies depending on the context and type of activity proposed. A “General Approval” usually applies to a University. A general approval may authorise the holder to:
perform the regulated activity for a scheduled substance for research, teaching or analytical purposes; or
possess a scheduled substance and administer it to an animal; or
possess supply or administer a medicine or poison for the purpose of providing a specialised program of health care.
You should however refer to the Queensland Health website to confirm the approval type or contact the University Scheduled Substance Manager for further advice.
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6.1 Approval process for research or teaching purposes
To use Medicines and/or Poisons for research or teaching purposes at a University follow these steps: 1. Consult with the local Drugs Officer and/or the University Scheduled Substance Manager
to confirm application process. 2. Complete the application form titled: Application to Chief Executive for an approval for
research or teaching purposes at a University 3. Complete a list of Medicines and Poisons document to attach to your application. 4. Consult with the local Drugs Officer (if available) and/or University Scheduled Substances
Manager to check application. 5. Submit application to Qld Health. 6. Provide copies of all endorsements to the University Scheduled Substances Manager
and the local Drugs Officer (if available).
The Applicant/Drugs Officer must forward a copy of the endorsement to the University Safety Team via [email protected]. Important: Queensland Health will not issue a reminder of pending expiry of any endorsement therefore it is the responsibility of the endorsement holder to submit a new application as required. A new application must be submitted for renewal if the use or possession is to continue after the expiry date of the endorsement.
6.2 Conditions of Approval
Any substance subject to an endorsement must only be used for the purpose as specified in the application and in accordance with all the conditions of the Authority (endorsement). Records shall be kept by the approved applicant of incoming and outgoing stock as specified in the approval and kept for a minimum of 2 years after the last entry is made.
It is also a condition of approval that any change in the criminal history of an individual for whom an endorsement applies must be disclosed to the Regulator within 24 hours.
6.3 Drugs Officer Conditions
Scheduled substances subject to an endorsement and controlled by a Drugs Officer must only include those obtained on the signed written order of a person holding the written endorsement. The Drugs Officer must only issue these drugs to a person from Griffith University holding a written approval under the Regulation.
6.4 Procurement
Purchasing shall be completed as per the University purchasing procedures. The procurement procedures require a purchase order to be raised within the finance system. All scheduled substances should be denoted by the requestor on the purchase request and approved by the relevant special approver. If purchases are completed outside of the purchasing system cost reimbursement for these orders will be refused.
6.5 Arrival at a Controlled Delivery Point
When Scheduled Substances are delivered to a Griffith University store or other controlled delivery point, the stores staff shall immediately advise the Applicant/Drugs Officer of the arrival. A record of the delivery must be kept and the goods held in a secure location. The goods must only be released by stores staff to the relevant Eligible Person or Drugs Officer.
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7.0 POSSESSION RESPONSIBILITIES
7.1 Records
Accurate records of substance transactions and quantities possessed must be kept by the authorised users at all times. A Scheduled Drugs & Poisons Log should be used to record all dispensing transactions. The log should be kept in a bound book with numbered pages. An example of the layout of the log is provided in Appendix 2. Please note that a separate page must be set up for each class of Scheduled substance and each controlled drug. Records must not be altered, but may be corrected by a single strikethrough with signature and date, and correct details. Records must be kept in good condition, and the log kept for at least two years after the last entry. Full details of each transaction must be signed on each occasion by the authorised user. Records should be kept in a location where they can be readily retrieved to facilitate audits. Groups, Elements or Institutes must ensure records are provided to the University Scheduled Substances Manager. Copies of all Drugs and Poisons endorsements, usage logs, transfer vouchers, destruction certificates and substance manifests must be regularly provided (at least quarterly) or when received from the Regulator (e.g. Qld Health), to the University Scheduled Substance Manager.
7.2 Disposal
Drugs and Poisons not requiring endorsement can be disposed of via the clinical and cytotoxic waste stream. Contact University Scheduled Substance Manager for assistance. Drugs and Poisons requiring endorsement must be forwarded to Queensland Health for destruction. Complete the Qld Health controlled drugs destruction form. The following procedure must be followed when forwarding expired/unwanted controlled drugs for destruction:
1. Complete the destruction form available from Queensland Health. Package each type and form of controlled drug individually. Mark each package with the number that corresponds to the controlled drug as listed on the destruction form.
2. Package together all individual packages. Ensure all items are held securely and prevented from damage in transit. Ensure the packages contain compatible absorbent material to contain any liquid in event of a breakage.
3. The outside of the parcel must be labelled with: Griffith University, campus address, and the description “Therapeutic Goods for Destruction” (do not detail the actual drug contents).
4. For transportation, use a suitable courier and ensure delivery confirmation is received. 5. Once destroyed, a destruction certificate will be received from Qld Health. Send a copy of
this to the University Scheduled Substance Manager and keep the original with the licence and drug usage records to maintain traceability. The destruction certificate provides accountability of drug stocks and must be retained for a period of two years.
6. Ensure the Scheduled Drugs and Poisons log is adjusted and marked as “Forwarded to Queensland Health for destruction.”
7.3 Labelling
At each campus, proper marking/labelling of packages and containers must be done to ensure the identity of the contents and their hazards are known. Drugs Officers and endorsement holders must ensure that:
packages of Drugs and Poisons are marked in accordance with the Regulation, SUSMP and Australian Dangerous Goods Code (7th Ed); and
if Drugs and Poisons are received without correct marking, they receive proper marking.
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7.4 Storage
Drugs and Poisons must be stored securely in accordance with the endorsement conditions and Regulations.
Schedule 2 and 3 substances (Medicines) should be kept in areas where there is no public access.
Schedule 4 (Drugs) must be kept in a cupboard, dispensary, drawer, storeroom or other area to which the public does not have access.
Schedule 7 (Regulated Poisons) Cyanide (includes any inorganic salt of hydrocyanic acid, other than ferricyanide or ferrocyanide salts) and strychnine should be stored in a locked cabinet that is reasonably secure and not accessible to children or the public.
Schedule 8 and 9 substances (Controlled Drug & Prohibited Substance) An authorised person in possession of a controlled drug must keep the drug in a locked cabinet that complies with the minimum requirements for a controlled drug receptacle or another secure place that is at least as secure as the requirements in Appendix 6 of the Regulation, and that has been approved by QLD Health. The authorised person must always keep the receptacle or secure place locked and personally possess the key or combination to the receptacle or place.
7.5 Restricted Access
Drugs Officers and/or endorsement holders must ensure access to locations in which Drugs and Poisons are held are restricted to appropriate persons. Where a location has limited security, the location should be considered as being accessible to the public. In these circumstances substances must be locked in a suitable container in accordance with the Schedule storage conditions listed in section 7.4 (above). Regular audits of access holders (both key and swipe card) must also be undertaken to ensure only currently authorised personnel have access to the location.
7.6 Inventory Control
Drugs Officers and/or endorsement holders must ensure that appropriate measures are in place to monitor the inventory of scheduled substances through the use of regular checks and stock take audits.
7.7 Unaccounted Drugs and Incident Reporting
Any incident involving a Drugs and Poisons (including a quantity discrepancy) must be immediately reported to the University via Gsafe as an incident and to the University Scheduled Substance Manager. In addition if a discrepancy between the quantity or volume of a class of controlled drug and the balance shown in the usage records is identified, then immediate written notice must be provided to QLD Health as per Section 116A of the Regulation. This should be done in consultation with the University Scheduled Substance Manager using the Qld Health notification form.
The University Scheduled Substance Manager will be required to follow up any incident involving a Scheduled substance with an investigation. The findings of the investigation including any recommendations will be reported to the University Biosafety Committee for consideration.
7.8 Transport
In order to ensure the safe and secure transport of substances to prevent them from being lost, stolen, misplaced or misused procedures should be in place to monitor the receipt of orders. In addition only licenced couriers must be used to despatch Scheduled substances. Any loss or other discrepancy that occurs during transit must be immediately reported as outlined in 7.7.
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8.0 Appendix 1: Simplified Process Flow Chart
Yes
Yes
Yes
No
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9.0 Appendix 2: Example Regulated/Controlled Drugs and Poisons Log
REGULATED/CONTROLLED DRUGS AND POISONS LOG
Chief Investigator Name of Compound Schedule Name and address of Supplier Storage Location
N.B. Include building and room number, and storage location as Fridge/Freezer/Safe/Cupboard/Drawer.
Date
User’s Name
Experiment / Procedure
Amount of
Drug
Received
(mg or g or
mL)
Amount of
Drug
Used
(mg or g or mL)
Balance of
Drug
Remaining
(mg or g or mL)
User’s Signature
Chief Investigator Date Page Number
These records must be kept for all Regulated/Controlled drugs and poisons for at least two (2) years after final log entry.