Throughout the years the regulations surrounding pharmacy compounding have changed rapidly and generated the most questions outweighing all other topics by far. In an attempt to demystify and shed light on the current regulatory landscape surrounding pharmacy compounding, compounded medications, and patient access, I have written this post.
Pharmacy regulations allow compounding of unique, novel, or one-of-a-kind combinations or version of medications prescribed by a physician. The major distinction between manufactured prescription medications one-size fits all approach is that compounded medications are individually tailored to an individual patient’s needs (e.g. flavor, dosage form, route of administration, dosage, and dosage combinations). Federal and state regulations allow for compounding any medications as long as the FDA has not removed, restricted, or banned that particular medication from the marketplace. In recent years, the Drug Quality and Safety Act (2013) gave regulatory authority to the FDA over compounded medications which was a major shift in the regulatory landscape for pharmacies.
While the driving factor for this change is patient safety, what has ultimately occurred is decreased patient access to compounded medications vital for patient health. I believe there is a responsible balance between patient safety and patient access that can be achieved; however the restrictive nature of current regulatory environment has created confusion for patients, prescribers, pharmacists, and pharmacies. As a premier pharmacy that offers quality compounded medications Trinova Health is committed to meeting all your health care needs which included access to vital compounded medication while adhering to the strict regulations. If you have any questions contact us today!
Silas Raymond, Pharm.D