Manufacturing and bringing controlled substances to market is highly complex and heavily regulated, requiring meticulous attention to detail and adherence to stringent standards that are set by local, national and global agencies.  Purisys is committed to regulatory compliance and standards while manufacturing controlled substance active pharmaceutical ingredients (APIs), implementing various practices and protocols to ensure it.

Much of what we do to ensure compliance involves the quota process. The main objective of the Drug Enforcement Administration (DEA) is to allow production of controlled substances for legitimate medical need while preventing their diversion for other purposes. The DEA issues quotas based on specific drug codes and approves them for manufacturing companies. Purisys, for instance, is approved for 71 different continuous integration and continuous delivery (CI-CV) APIs. These quotas are established to ensure that production aligns with legitimate medical needs, preventing excessive manufacturing and stockpiling of product classes.

Purisys has established a “chain of custody” to account for the number of controlled substances we have on site and to ensure we have the appropriate quotas for the DEA. It starts with our employment practices. Each employee must pass a thorough background check and drug screening to confirm that they meet the qualifications to work with controlled substances.

Precise documentation is another critical aspect of compliance efforts. Our batch production records are meticulously written to abide by all controlled substance laws. This ensures transparency and accountability throughout the manufacturing process, providing a clear trail of compliance for regulatory agencies to review.

Our multi-million-dollar, walk-in vault is certified to store controlled substances, and it is DEA-approved and tested regularly to maintain its certification. We have also installed high-tech, fingerprint-based lockers to prevent unauthorized individuals from accessing the vault.

With these established processes and by providing the DEA detailed information about our customers’ legitimate medical needs, we ensure compliance with quota regulations while preventing stockpiling. The expertise we have in navigating this process enables us to effectively manage quotas to meet customer demands.

Handling High-Potency and Controlled Substance APIs

As we develop APIs, Purisys adheres to strict standard operating procedures (SOPs) to ensure every step is executed with precision and compliance.

We employ a team of highly trained manufacturing technicians who follow current Good Manufacturing Practices (cGMP) established by the U.S. Food & Drug Administration (FDA) and have completed cGMP training. We also invite certification companies to visit our production facility to certify our technicians as HAZMAT-approved. This additional layer of scrutiny ensures that personnel are fully qualified and capable of handling controlled substances safely and responsibly.

Maintaining compliance with the DEA and FDA adds an extra level of complexity to operations. Adhering to the rigorous requirements of both organizations demonstrates our commitment to upholding the highest quality and safety standards in the controlled substance manufacturing industry.

International Expertise

Purisys ships product to more than 40 countries, helping customers navigate regulatory bodies in the international market in addition to FDA and DEA requirements. International distribution has unique requirements. When you do it, you have to involve yourself with the DEA-equivalent in every country, and each of these organizations has their own set of rules.

International regulations established by the International Narcotics Control Board (INCB) govern the import and export of controlled substances. The INCB estimates the needs for each drug code (similar to the DEA quotas discussed above) for every country. We work with customers to establish their estimated needs for each export destination.

To operate in these countries and obtain export permits, we work with their health authorities or governing bodies to complete the necessary paperwork. We have developed internal systems to assist customers in obtaining the required documents, ensuring accurate information and the acceptability of controlled substances being shipped.

We understand the complexities and regulations involved in manufacturing controlled substances. Whether it’s managing quotas, navigating international regulations, or securing permits, our experienced team is here to guide you every step of the way. Contact Purisys today to discuss how we can help you bring your controlled substance APIs to market.