The state of Florida regulates pharmaceutical compounding locally, and every state has their own state governing bodies that oversee the pharmaceutical compounding in their respective states. Licensed 503B facilities are legally able to issue compounded prescriptions to facilities such as medical hospitals, clinics, doctors’ offices, and other medical institutions, however, compounding pharmacies that are not 503B cannot do this legally. There are some compounding pharmacies that claim that office use compounding is illegal in Florida, but any pharmacy that claims this should be viewed with skepticism. Many of these pharmacies are operating without a 503B license, and as a result they are may have something to hide. They often break FDA regulations when operating their pharmacies, and the products that they issue may be dangerous or improperly created.
One thing to always remember when looking for a compound pharmacy is the fact that office use compounding is perfectly legal in the state of Florida. With the proper 503B license office use compounding is legal and compounding pharmacies are free to issue compounded medications to facilities. When any pharmacy tries to claim that office use compounding is illegal, they are often trying to discourage customers from using legitimate pharmacies in Florida. They also will often say this to avoid FDA inspections and they try to do anything that they can to avoid FDA oversight. If you are a physician, medical clinic or office seeking sterile compounding pharmacy services, always remember that a licensed 503B facility such as Absolute Pharmacy can issue your compounding prescriptions as you need, and there are no state or federal regulations against this. If you ever find a pharmacy or company that claims anything other than this, you should avoid using them at all costs and keep in mind that they are lying to their customers.
Absolute Pharmacy is registered with the FDA as a legitimate outsourcing pharmacy, and there are strict requirements to be registered as a 503B facility. Absolute Pharmacy was approved by the FDA as an outsourcing facility because we abide by the FDA’s regulations and requirements including reporting specific information about the products that we issue, information about the sources of our ingredients, and other requirements. There are several other facilities in the state of Florida that are not 503B facilities, and as a result they are not eligible to issue their prescriptions to offices and medical clinics. They also are not required to abide by the FDA’s regulations, and more often than not a facility will be breaking FDA regulations and unable to qualify for 503B status, which is why many facilities go to great lengths to avoid 503b regulation.
After a meningitis outbreak and a few other public health cases, the FDA has started to become increasingly focused on oversight. Aggressive inspections of compounding pharmacies are necessary in order to protect the public’s health, and product quality is a major concern for the FDA. As a result, any facility that does not meet 503B regulations may not be safe to use because they are operating without FDA oversight, which can be a major issue when it comes to product quality. FDA oversight ensures that the quality of compounded medications that are produced by a facility will be on par in terms of purity and quality with commercial drug companies, however facilities that lack oversight may produce medications that are impure, low in quality, or potentially hazardous in rare cases.
Any clinic or physician that needs drug compounding services should try to work with a 503B facility. The FDA publishes a list of these facilities on their website, where you can see Absolute Pharmacy and a few others throughout the nation listed. These facilities are safe to use for clinics that need high quality, pure, and safe compounded medications. In many cases, medications can be shipped to other parts of the country safely as well, so clinics outside of the state of Florida are often able to use the services provided by Absolute Pharmacy, and clinics that are in the state of Florida should absolutely use our services to ensure the safety of their patients and the quality of their compounded medications. The 503B designations means that our facility has passed the intensive inspections of the FDA and that the quality of our products and their purity is guaranteed.
Again, it is important to assert that companies that claim office use compounding is illegal are often trying to misguide customers to the fact that it really is legal as long as a facility is registered under 503B. The biggest problem in the world of compounding pharmacies is the lack of oversight, and many companies want to mislead their customers to think that that oversight is not a necessary part of the process simply because of the fact that they don’t have the facilities or capability to meet 503B specifications. There can be serious issues with products that are produced by low quality compounding pharmacies that cannot meet FDA regulations. Essentially, the safest route is always to work with a 503B outsourcing facility like Absolute Pharmacy, but you always want to avoid facilities that make false claims about office use compounding.
As it stands now, each state’s Board of Pharmacy is the main governing body that regulates compounding pharmacies locally. The State Board of Pharmacy for Florida has the ability and discretion to shut down any organization or pharmacy that is operating dangerously, and many State Boards of Pharmacy have started to mimic the regulations of the FDA when it comes to the oversight of local compounding pharmacies. As a result, the companies that cannot meet 503B standards are more likely to run into issues in the future as State Boards of Pharmacy become stricter and stricter with their regulations. These strict regulations have become necessary with the large number of unlicensed compounding pharmacies that are issuing medications without abiding by industry best practices and safe production standards, and with a few cases in the past in which patients were injured from the products made by these pharmacies.
In spite of what unlicensed compounding pharmacies would like, the FDA will continue its oversight of these pharmacies, and many may be cautioned or possibly shut down in the near future as a result of poor production practices or other legal issues with their operation. Although compounded medications are never approved by the FDA since they are custom made for each specific patient or purpose, the production process that creates these medications is always crucial. The FDA will continue to crack down on unlicensed pharmacies that put their patients and customers at risk by avoiding the oversight necessary to ensure that their drug production is safe. By working with a 503B registered facility you can ensure that you or your patients are using high quality compounded medications that are made with the utmost concern for purity, quality and sterility, while other facilities cannot make these promises. Get in touch with Absolute Pharmacy today if you have any questions at all about office use compounding or if your office or clinic needs a high quality source for compounded medications.