Controlled Substances
Testing, Development and Storage
In an era marked by advancements in pharmaceuticals and medical treatments, handling of controlled substances and highly potent drugs demands precision, expertise, and an unwavering commitment to safety and compliance. PharmSky has experience in the handling and storage of controlled substances and highly potent drugs. We recognise the unique challenges associated with the use of these substances and offer specialised services to support organisations to advance the development of new therapies containing these compounds. All material that enters our site is receipted, stored, and managed following detailed processes to ensure traceability throughout its life cycle up to and including despatch or destruction. If required, vendor qualification of suppliers can also be completed. PharmSky is committed to maintaining stringent safety protocols and quality and regulatory compliance to guarantee the wellbeing of our staff and the quality of your product.
Controlled Substance Manufacturing
PharmSky manufacturing of controlled substances comply with strict GMP standards, secure storage conditions and record-keeping requirements.
Medicinal cannabis and psychedelics are promising treatments for addressing specific clinical conditions and improving patient well being. At PharmSky we are committed to navigating this dynamic landscape and providing comprehensive services to support businesses and organisations developing medicinal cannabis and psychedelic products. PharmSky has licences to store and handle medicinal cannabis and psychedelics and we offer well-established in-house services ranging from analytical testing, ICH stability, regulatory compliance, formulation optimisation, early stage and phase 1 clinical trial manufacturing. These services highlight our expertise and dedication to foster positive change for patients who require these regulated medicines.
PharmSky is licensed by the Victorian Department of Health to possess and store Schedules 2, 3, 4, 7, 8 and 9 medicines. Scheduling is a classification system in which medicines and chemicals are categorised into schedules to control their availability according to the level of regulatory control required to protect public health and safety. The scheduled medicines and chemicals covered in Pharmsky’s license are:
Schedule | Details |
2 | Pharmacy medicine |
3 | Pharmacist only medicine |
4 | Prescription only medicine or prescription animal remedy |
7 | Dangerous poison |
8 | Controlled drug |
9 | Prohibited substance |
Highly potent drugs are substances that have a strong pharmacological effect at low doses. These drugs typically have a high affinity for their target receptors or enzymes, meaning they can produce significant physiological or psychological effects even in small amounts. Typical examples include fentanyl, LSD and many chemotherapy drugs.
The nature of highly potent compounds means they pose a significant risk to anyone who comes in contact with them, even peripherally. This is especially true for active pharmaceutical ingredients (API) which are often supplied as very fine powders and are highly susceptible to forming dust clouds. As such, any facility handling these compounds, needs to institute effective controls and employee training to minimise the risk associated with their handling. PharmSky have the processes in place to risk assess, store and handle highly potent drugs and our employees are experienced in their use. If you are looking for a facility which can safely manage the formulation development and/or analytical testing of your highly potent drug, get in touch with us today.
Why Choose PharmSky To Partner With?
We offer well-established services ranging from analytical, stability, regulatory, formulation optimisation, early stage, and manufacturing in compliance with regulatory requirements.
PharmSky can assist clients with the application process for importing controlled substances, ensuring full compliance with Australian regulatory requirements.
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Frequently Asked Questions
Schedule 8 and 9 medicines must be stored in a locked, secure area such as a controlled room or controlled cabinet with restricted access. These areas should also be monitored to ensure security.
- Locking systems: Controlled areas must have secure locking systems that prevent unauthorised access.
- Surveillance: Security systems, such as cameras, alarms, and access control systems, may be required to monitor and track access to storage areas.
- Restricted access: Only authorised personnel should have access to controlled substance storage areas, and access should be logged for auditing purposes.
- Environmental conditions: Some controlled substances may require specific environmental conditions (e.g., temperature, humidity) to maintain their stability and efficacy, which must be monitored and controlled.
