According to the U.S. GAO, compounded drugs account for about 1-3% of all U.S. prescriptions. Compounding pharmacies are a vital part of the overall pharmaceutical industry, and they continue to experience modest growth driven by an aging population suffering from chronic diseases requiring personalized dosages or ingredients.
Traditionally, compounders formulated drugs prescribed by doctors for specific patient needs typical prescription drugs can’t fulfill. For example, a compounding pharmacy may change a drug’s formulation from a pill to a liquid form or exclude an ingredient for a patient with an allergy. Most recently, compounding pharmacies have been tasked with helping alleviate local drug shortages.
According to the American Pharmacists Association, of the 56,000 community-based pharmacies in the US, about 7,500 specialize in compounding services. These pharmacies have made major contributions to patient care by dispensing pharmaceuticals that otherwise may not have been available. Pharmaceutical compounding is essential to the progression of the pharmaceutical industry and personalized medicine.
What are some of the benefits of pharmaceutical compounding?
· Enhanced Medical Compliance
For some drugs, side effects are commonplace – potentially leading to higher rates of patient non-compliance. Sometimes side effects are more than mere inconveniences – they can be potentially life-threatening adverse events. Compounding pharmacies can increase compliance and mitigate the risk of adverse events by substituting potential allergens with alternative ingredients.
Palatability or another aspect of the delivery method may also cause reductions in compliance. Children, for example, are not keen on taking larger tablets meant for adults. Adults – especially the elderly or those who have trouble swallowing – may also want to avoid large tablets. Compounding pharmacies may offer to cut these tablets or formulate a liquid version of the drug, offering an alternative solution for patients with a specific medical need.
· Solutions for Drug Shortages
While drug shortages have been on the decline in the U.S., they continue to be a major problem worldwide. Healthcare providers are often limited in their treatment options by the availability of drugs within their regions or communities. Compounding pharmacies are typically equipped with the ingredients and technology to produce drugs that may not be available, resulting in more options for healthcare providers, improving communities’ overall quality of health.
· Reaching the Underserved
Some patients are underserved by the pharmaceutical community due to cost or lack of access. For example, drugs that must be shipped into a community can cost more than those manufactured locally. Compounding pharmacies are more local and community-affiliated, providing access to patients who may otherwise be excluded from access.
5 Things Compounding Pharmacies Need from API Suppliers
Compounded drugs may offer many benefits, but they aren’t actually FDA-approved, so they do not have some of the same safety and quality assurances as approved drugs. As a result, in the past issues have sometimes emerged with compounded drugs, like the 2012 incident in which a Massachusetts-based pharmacy shipped contaminated compounded drug, leading to the death of 60 people.
To avoid such a catastrophe, compounding pharmacies need to look for a few key qualities from their API suppliers.
1. Strict Adherence to cGMP Guidance
In a recent article, the FDA stated that “improper repackaging or lack of supply chain oversight of APIs can cause serious vulnerabilities in the supply chain and may lead to patient safety issues.”
For this reason, compounding pharmacies should look for an API supplier that has a long history of adhering cGMP guidelines, as described by the FDA to ensure the quality of drug products. Among the key requirements: methods, facilities, and controls used to manufacture and package a drug product.
2. Updated FDA Registrations
Domestic and foreign establishments that manufacture, repack, or re-label drug products in the U.S. must register with the FDA. They are also required to list all of their commercially marketed drug products, which the FDA maintains in a catalog of drugs in distribution. Ensure your API supplier is committed to maintaining compliance with all FDA guidelines, including possessing all required registrations.
3. Valid NDC Registrations
In the FDA’s National Drug Code (NDC) Directory, drugs are identified and reported using a unique, three-segment number, called an NDC number. This directory contains information on the active and certified finished and unfinished drugs submitted to the FDA in structured product labeling. The drug company submitting the information is responsible for the accuracy of the listing data, so it’s critical to use an API supplier with valid NDC registrations.
4. Approvals by the Leading Regulatory Authorities
Consumer safety is the top priority within the pharmaceutical industry, which is accomplished partly through regulating authorities. The rules and regulations from these authorities protect people from harm from prescribed drugs. So if the FDA does not regulate compounded pharmaceuticals, who does? It’s complicated. State agencies oversee the pharmacies, the Drug Enforcement Agency oversees the handling of the drugs, and the FDA oversees the integrity of the APIs. This complex, multi-tiered oversight underscores the need to select API providers who are committed to maintaining approvals and navigating all leading regulatory authorities.
5. Fully-Compliant API Quality
Active Pharmaceutical Ingredients (APIs) are the most important components of manufactured drugs – and quality compliance is non-negotiable, especially for compounding pharmacies because of the complex nature of the work. For this reason, compounding pharmacies must work with an API supplier that tests and sources the best quality materials and meets all applicable guidelines.
You may have noticed that compliance and quality are the underlying themes of selecting an API supplier for pharmaceutical compounding. Regulations around the pharmaceutical industry are in place to protect patients, so it’s critical to find an API supplier that is highly diligent with all compliance and regulatory requirements. One popular path when navigating API suppliers for compounding pharmacies is to work with a sourcing partner who maintains quality assessments of their various API suppliers and can find the right match based on your specific criteria.
LGM Pharma has more than 20 years of supplying quality APIs to many leading repackaging distributors that cater to the US compounding industry. The due diligence required to separate high-quality ingredients from the rest is increasingly expensive and time-consuming. Our process reduces cost and saves you time getting high-quality APIs to your door. Contact us to learn more.
