The FDA or Food and Drug Administration maintains compliance policy guidelines that pertain to the practice of compounding pharmacies. These guidelines state which medications may be compounded and which medications may not be compounded into final formulations. Most notably they state that all the medications used must have passed the NDA or New Drug Application process and have been approved for use in other formulations in the United States.
The FDA approval process is intended for mass-produced drugs made by large manufacturers. Because compounded medications are personalized for individual patients, it is not currently possible for each formulation to go through the FDA’s drug approval process. This process takes years to complete and is prohibitively expensive, often costing hundreds of millions of dollars.
Our compounds are supported by extensive medical evidence and research, as well as clinical applications and patient and physician feedback results.
However, there are those who try to portray compounded medications as unsave and unregulated. They state that compounded medications are not FDA approved to mislead as well.
We are in full compliance with the FDA. However, the FDA can regulate compounding pharmacies, but they choose to leave the decisions to each individual state board of pharmacy. All essential medications used in our formulations are purchased from FDA approved sources and the active ingredients are FDA approved. FPS has passed USP-795 and is a verified pharmacy prescriber.
We compound medications from premium suppliers such as PCCA and Medisca, whose safety have been quality tested and verified. These medications have been on the market for years now and have proven efficacy and safety thus far. While the state boards of pharmacy are the regulatory body for compounding pharmacies, the FDA regulates manufacturers.
The FDA requires that the established triad relationship between the patient, physician and the pharmacist be intact to establish a non-manufacturing pharmacy model. The FDA recognizes the need and value of compounding for specific patient needs and the prohibitive cost and time requirement of the NDA process for every compounded formulation.
We undergo routine inspections by the state boards of pharmacy and are in complete compliance. Our compounds are tested for potency to ensure safe and proficient processes by state boards of pharmacy.
Furthermore, our compounded preparations have been reported typically safer than oral medications due to their usually non-systemic and reduced side effects such as drowsiness, swelling, constipation and effects on organs such as the kidneys and liver.
Also, the amount of medication required for transdermal delivery is typically much less than what is taken orally and our formulations are usually able to achieve higher tissue specific concentrations.