Making sense of controlled substances

Navigating complex regulatory requirements with the right outsourced partner.

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The strong potential of controlled substances in areas like ADHD and substance abuse treatment has contributed to their significant growth in API development and manufacturing over the past several years. In addition, certain controlled substances proved useful in COVID-19 treatment early in the pandemic,

prompting regulatory authorities to make critical therapeutics more accessible to patients

. However, stringent regulatory and safety requirements make it challenging for organisations without the proper infrastructure to handle controlled substances in-house, confirming the importance of identifying and engaging the right outsourced partner.

The controlled substance market is expected to grow at a CAGR of 5.4% through to 2027.

The growth of controlled substances and the prevalence of outsourcing.

With controlled substance pharmaceuticals on the rise

, developing and manufacturing controlled substance APIs requires strict safety controls, licenses for development, manufacturing, testing, importing, and exporting, and specialised expertise. As a result, many organisations outsource controlled substance handling to CDMOs. With the necessary infrastructure already in place, an experienced outsourced partner mitigates the time, cost and regulatory barriers associated with handling controlled substances, streamlining a product’s path to market.

Controlled substances comprise about 10% of prescriptions written in the US.

How can you select the right partner for your controlled substance projects?

In pharmaceutical development and manufacturing, each stage of the product lifecycle brings about its own key regulatory requirements and considerations. To best position themselves for regulatory approval, organisations require an outsourced partner that delivers support and expertise at each key stage—preclinical, clinical and commercial—and is committed to positioning each project for long-term compliance success.

Regulatory compliance

The regulatory landscape around controlled substances is exceedingly difficult to navigate. Look for a partner who is licensed to handle controlled substance development, manufacturing and testing, as well as importing and exporting. Beyond simply having the necessary certifications, your partner should also maintain a close relationship with regulatory agencies like the DEA and Home Office, regularly engaging with them to assess whether products are likely to be scheduled.

Security infrastructure

To ensure ongoing compliance and safety, your outsourced partner must maintain stringent security controls for controlled substances. Detection systems, vibration controls, secure store, around-the-clock monitoring and other measures are all critical safeguards. These control measures should meet the regulatory standards for Schedule I controlled substances, which have the greatest potential for abuse.

Extensive experience

Beyond having the necessary controls and licenses in place, your partner should have a strong track record working with the full range of controlled substances in previous engagements. The right partner will leverage this expertise to guide you in navigating regulatory requirements, preparing for commercialisation, and other key areas. It should also be adept in handling the small batch sizes that are often necessary for low-dose, controlled substance APIs.

Full-lifecycle capabilities

Finally, a partner should be well-versed in all aspects of the molecule lifecycle to maintain full continuity throughout your controlled substance project. Expertise in areas like analytical chemistry and cGMP manufacturing, as well as proven experience scaling projects from preclinical development to commercial scale, are important to ensure the success of your project at every stage.

Service

We pride ourselves on being easy to do business with, removing layers of complexity, maximising flexibility and adaptability to your requirements, and doing what we say we will do, again and again.

Passion

We promise to treat your molecule as our own, drive progress by continually exploring new and emerging capabilities, and do the right thing for our people and planet.

Science

We combine our expertise in complex and hazardous chemistry, our world-class facilities and our full-lifecycle capabilities to place scientific excellence at the core of every solution we deliver.

Comprehensive expertise in controlled substance development and manufacturing.

At Sterling, we have extensive experience working with controlled substances while adhering to the highest quality, regulatory and safety standards. Our Dudley facility in the UK and our Cary, North Carolina and Germantown, Wisconsin facilities in the US are licensed to handle Schedule I-V controlled substances, and our end-to-end expertise enables us to successfully scale projects from grams to tons. Most importantly, as a PDMO, or partnership development and manufacturing organisation, we maintain close collaboration and full transparency with our customers to maximise their projects’ success.