The FDA is a group that is tasked with ensuring the safety of food and drugs in America. To do this, they regulate the manufacturing process for all pharmaceuticals. Recently, there has been some controversy about whether or not compounded medications should be controlled by an FDA Regulatory Affairs Expert.
Many people are concerned that if the FDA regulates these drugs, it will increase prices and limit access to treatment options for patients who need them most. In this blog post, we’ll explore what you should know about compounding and where the FDA comes in.
Compounding is when a pharmacist prepares medications by mixing or altering ingredients to meet the specific needs of their patients. It can be done for people who have trouble swallowing pills, those with allergies to certain components in prescription drugs, and others who need medically tailored dosages.
Why Some Patients Need Compounded Drugs
Compounded drugs are used to treat conditions that cannot be addressed with FDA-approved medications. For example, some patients who have cancer may require specially designed or modified treatments for a specific type of tumor.
These specialties could include oral oncology (treating tumors in the mouth), neurology, and neurosurgery (treating brain disorders). Some types of chemotherapy can also only be made by compounding pharmacists because they would not meet the safety standards set by regulators.
Does FDA Approve Compounded Drugs?
The FDA does not approve compounded medications as they are created according to the prescriptions from health care providers and individual patients. Compounded drugs can be used to provide customized treatment options for people who cannot afford or obtain FDA-approved treatments, such as those dealing with allergies to specific substances found in many generic medications.
This may also include having different doses than what is available for approved drug products.
What Are The Risks Associated With Compounded Drugs?
The FDA warns people that compounded drugs may carry serious risks, which are not always evident to patients. The FDA reports these drugs have led to rare but severe adverse reactions like pneumonia, kidney damage, and death associated with various surgical procedures such as spinal injections for back pain relief.
What Should You Do To Ensure You’re Getting Safe Drugs?
There are many resources out there designed to help you find pharmacies that produce safe medications. The National Association Of Boards Of Pharmacy’s website lists pharmacy websites where consumers can look up a pharmacy’s status. You can also ask your physician to recommend a safe pharmacy for you.
The FDA has compiled recommendations on how patients should find safer options when they have medications that are not available from their normal pharmacies:
– Talk with your doctor about the medicines or products you need and where else you can get them.
– Ask other family members, friends, neighbors, and co-workers if they know about similar drugs in different forms made by other manufacturers.
– Contact wholesalers who distribute prescription drugs.
– Contact specialty pharmacies like Omnicare, which specialize in meeting specific medical needs of people living at home – these facilities maintain inventories of thousands of drugs.
– Contact firms specializing in importing medications from other countries where they are less expensive or not available at all, such as Canada.
The FDA is trying to protect the public from dangerous, unsafe drugs. Compounding pharmacies are not required by law to register with the FDA and can make their own decisions about what needs to be done in handling potentially harmful products.