As we all know, Polidocanol has become difficult to find over the last year or so as a result of regulatory changes that affected the compounding pharmacy environment. There was a time when we could call virtually any compounding pharmacy and get them to make any strength or vial size that we wanted, but that changed with the passage of the Drug Quality and Security act in 2013.
In late 2015 we started to see Polidocanol become available again in small quantities from only a few compounding pharmacies. The two types of compounding pharmacies we saw re-enter this market were the traditional compounder and a new category of pharmacy referred to as a “503B Registered Outsourcing Facility”.
What is a 503B Registered Outsourcing Facility? The Drug Quality and Security Act created a new designation of compounding pharmacy, referred to as an “FDA Registered Outsourcing Facility”. This new designation refers to a facility who is required to maintain a higher standard of quality and testing than a Non 503B compounding facility; consequently, Polidocanol is typically more expensive than a non-503B product, but is usually still less expensive than a commercially available product.
During a media briefing, FDA Commissioner Margaret Hamburg, MD, said: “Helping to protect Americans from unsafe drugs is among the FDA’s highest priorities and is part of our core mission.” She explained that the DQSA “represents a step forward by creating a new pathway in which a compounder can register with FDA as an outsourcing facility.”
Compliance with the law: In accordance with this new law, ONLY a 503B outsourcing facility can provide medication to be administered by physicians or other medical staff. This means that any and all medications (like Polidocanol) that are administered in office must come from an FDA Outsourcing Facility.
Peace of Mind: FDA Registered Outsourcing Facilities are held to a much higher standard than a traditional compounder. These FDA Registered facilities typically source their active Pharma Ingredients from an FDA approved distributor who follows CGMP guidelines. (CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA). CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. FDA Registered Outsourcing facilities are required to maintain the same CGMP specifications as commercial pharmaceutical companies.
Summary: It appears that according to these new regulations, only FDA Registered Outsourcing facilities are allowed by law to ship medications that are to be administered by a medical provider or clinic staff. If a provider is sourcing Polidocanol from a Non 503B facility, and they get audited, they could possibility run the risk of serious legal action. Thinking about patient safety recently, a clinic physician summed it up best when he said ” I don’t want to be the guy who has to explain to a jury why I bought a sterile injectable from a neighborhood pharmacy when there was a higher quality product available from an FDA registered facility. Medication is nothing to be cheap about”.