Where The Supply Chain Begins
Pharmacies that practice compounding need active pharmaceutical ingredients (APIs) to manufacture prescription medication. These are the ingredients that produce therapeutic effects and can be used to create medicines in unique forms. How raw materials are sourced and processed is essential to the success of compounding pharmacies. Understanding the API supply chain, which involves sourcing, manufacturing, and distributing the ingredients, can help pharmacies make smarter decisions. Compounding pharmacies can also meet patient demand, especially when there are delays or shortages of common mass-produced drugs.
Factory floor to pharmacy door
Pharmacies that decide to provide alternatives to specific drugs must have a clear understanding of the supply chain. Most API supply chains start with researchers who then work with manufacturers to create the active ingredient. Overseas manufacturers, primarily in Asia and Europe, receive raw materials from suppliers, then produce these ingredients in large facilities. Each manufacturer has rules and regulations that govern if certain ingredients can be distributed. Approved ingredients can then be shipped via air or sea to international ports. Once cleared, distribution centers of varying sizes receive and sell these ingredients to large pharmacies or smaller compounding locations. This is a simplified explanation of a complex API chain that involves many stakeholders, approvals, and technology to ensure a smooth transition.
Your quality checkpoints
Pharmacies must ensure that ingredients are accurate and of high quality to make the best possible medications for patients. Verification steps along the supply chain ensure patient safety. Pharmacies are encouraged to check the certificate of analysis (COA), which ensures testing to meet standards before distributing. Regulatory agencies also sit within the supply chain and may provide information on the safety, efficacy, or approval of ingredients. Check with these agencies as well for more information. Another quality checkpoint is with the distributor. The best distributors deploy additional 3rd party testing to confirm the manufacturer's results. Make sure additional testing is part of the pharmacy’s checkpoints. Another useful check is ensuring the manufacturer and distributor align with current good manufacturing practices (CGMP) for quality and consistency.
Your main player in the API chain
Pharmacies are often involved in the back end of the supply chain. Many work directly with distributors, brokers, and traders. Distributors are the most direct link for pharmacies. Some compounding pharmacies have relationships with smaller distributors that allow easier sourcing of APIs. Distributors purchase supplies from manufacturers and perform quality checks to meet the needs of pharmacists. As a result, the pharmacy can sometimes recreate a drug that is in low supply or no longer available. Some prefer to work with brokers and traders who do not handle the API but are intermediaries that facilitate sales. Having access to each option and knowing which is best for sourcing ingredients can help pharmacies maintain a safe supply.
Finding and vetting your API supplier
There is no harm in understanding and verifying all API suppliers. The pharmacy’s reputation comes back to providing the best possible service to patients, with safety and efficacy pillars to success. Pharmacies often have access to databases of suppliers and can interact with the team at any time. After choosing a supplier, use paperwork to verify the quality and journey of the API. The COA confirms purity, potency, and compliance. CGMP and safety data sheets provide the necessary information on handling, storage, and safety. Do not hesitate to check this information on different batches.
Supply chain links to patient health
Knowledge of the API supply chain ensures consistent quantities of the ingredients needed to complete medication and meet demand. Pharmacies that need API, like compounding pharmacies, are essentially the last part of the supply chain. Using a substandard API can have significant health consequences. Double-checking the supply chain fulfills the responsibility of providing safe, high-quality medication to treat patients. Make sure the supplier provides a COA with every batch, performs in-house testing and re-testing, and focuses on quality assurance. Tracing the API back to the manufacturer should be easy, without any gatekeepers. Work with distributors and manufacturers who are transparent, have excellent reputations, and put patients first.
