Polidocanol and Sodium Tetradecyl Sulfate (STS) have long been considered the gold standard for vein treatment worldwide, and we are pleased to offer these products for immediate shipment to your clinic.
We represent several of the countries leading 503B FDA registered Outsourcing facilities/compounding pharmacies who produce Polidocanol, STS, and other products that are available by special order.
Polidocanol is currently available in the following strengths / vial sizes:
- 1.5% 5ml vials
- 3.0% 5ml vials
- 3.0% 30ml vials
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.
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.”
Peace of Mind
We believe that FDA Registered Outsourcing Facilities maintain higher standards than a regular compounding pharmacy. 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.
Please contact us for pricing, delivery or additional information on sclerosants or other compounded products.