Compounding: A Solution For Patients Who Cannot Take FDA-Approved Medication

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Sometimes FDA-approved medications have ingredients that some patients cannot tolerate. Rather than forgoing the benefits of the medication, health care providers can turn to compounding pharmacy solutions

Understanding compounded medication

Pharmacists can compound medications by mixing, combining, or changing ingredients to meet a patient’s unique needs. While this solution works for many patients, it’s important to know that the FDA does not approve compounded medications. This can create a problem for people who rely on their health insurance coverage to pay for medications. When pharmacists create a compounded medication, the patient usually has to pay the full out-of-pocket price. 

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Why prescribe compounded drugs

Drug manufacturers use a variety of ingredients when making their FDA-approved medications. Occasionally patients have issues relating to specific ingredients. They could be allergic to an ingredient, or they need the medicine in a liquid form rather than a capsule. Health care providers will make compounded variations with the same effective ingredients, but in a different form and without certain inactive ingredients, like unnecessary dyes. 

Compounded drugs can serve a patient’s needs, but some compounding professionals use unethical practices when making special medications. Before choosing a compounding pharmacist, consult with your health care provider to find a reputable one that uses safe practices. 

Why compounded drugs aren’t FDA-approved

The FDA cannot verify individual drugs made by compounding pharmacists, as each mixture is specially designed for an individual patient. The FDA looks at medications used by the majority of consumers and health care providers. The organization assesses the drug and the manufacturing practices to ensure it is safe and effective for the general public. 

Risks of using compounded drugs

Health care providers rely on compounded drugs to meet the needs of their patients, but the compounding practice comes with risks. Health care providers should only use compounded drugs when necessary because the mixtures cannot be approved by the FDA. Poor practices can contaminate the drugs and create more problems for patients. A pharmacist could accidentally add too much or not enough of an active ingredient and cause a serious health issue that could lead to death. Some pharmacists try to save money by using unsterilized tools, which can add bacteria and other toxic elements to products patients need. 

Who compounds drugs?

Pharmacies are the most common place to find compounded drugs. However, many pharmacists do not compound drugs because the practice is too risky and time consuming. Because so few local pharmacists compound medications, many health care providers turn to outsourced facilities that are inspected by the FDA and have additional quality standards in place to protect patients. 

Are compounding facilities inspected?

While the FDA and other inspection agencies cannot inspect every drug compounded by a pharmacist, they can inspect the facilities. The FDA does not watch over every action a pharmacist does, but they will conduct inspections if patients register complaints. Outsourced compounding facilities have routine inspections to ensure they are following sterilization and other health-related standards. 

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