PHARMAGEN IS NOW A REGISTERED 503B OUTSOURCE FACILITY WITH THE FOOD AND DRUG ADMINISTRATION (FDA).
On November 27, 2013, President Obama signed the Drug Quality and Security Act (DQSA) as a result of the New England Compounding disaster, the legislation contains new rules relating to sterile compounding. Outsourcing facilities:
- Must comply with CGMP requirements,
- Will be inspected by FDA
- Must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.
Pharmagen welcomes the Food and Drug Administrations oversight of sterile compounding and is excited about the future of the sterile compounding industry. As always, Pharmagen remains committed to being your best in class provider of sterile and non-sterile compounded products.
With a multifaceted approach, Pharmagen, Inc. is meeting the demands of the health provider market through dynamic, independent wholesale, compounding/admix, and innovative IT solutions. Nationally focused, we are a distributor of specialty drugs, FDA registered 503B Sterile outsourced facility, and a producer of over-the-counter (OTC) branded multivitamins. The Food and Drug Administration continues to see an increasing number of shortages, especially those involving sterile injectable drugs. We currently function as a total solution provider to hospitals, offering both sterile compounding/admix pharmacy and a just-in-time supply of products that are hard to find due to drug manufacturers’ production shortages. Leveraging our understanding of drug shortages, our long term goal is to become an FDA approved manufacturer of habitually short supply, sterile pharmaceuticals. Through an industry changing, cGMP + ® process, employing single-use, modular systems, we intend to be the gold standard of sterile production in the United States.
In addition to pharmaceuticals, we manufacture and distribute over-the-counter (OTC) branded health supplements. Our innovative approach to OTC is to create suites of products designed to work in conjunction with prescription medications to alleviate side effects and/or prevent drug interactions. With an aging population, more Americans than ever rely on prescription medications, and dangerous drug interactions are a growing problem. We are currently analyzing several OTC products that would allow us to become a powerful player in the multi-billion-dollar health supplement market.
Pharmagen Laboratories specializes in the formulation of drugs that are not commercially available, or those requiring alternate delivery systems or custom dosages. Our pharmacists use the most advanced technology, FDA-approved chemicals, and a comprehensive inventory of formulas, ensuring patients’ customized medications meet exact practitioner specifications. From topical creams and lozenges, to ophthalmic drugs and erectile dysfunction formulations, patients’ prescriptions are individually prepared by experienced Compounding Pharmacists in our state-of-the-art USP 797 sterile room.
Our staff of pharmacists are available for patient consultations. Please call 800-798-7279 to speak with a Compounding Pharmacist.
Pharmagen Laboratories provides high-quality formulation and consultation services for healthcare practitioners, concentrating on specialty practices. By maintaining extensive profiles and sharing clinical experiences, we are a resource for physicians, often in the management of clinical evaluation programs and investigational protocols.
Pharmagen Laboratories, Inc.
Pharmagen Laboratories is not a retail pharmacy with a compounding component, but a compounding-only pharmacy. If you are local to the Stamford area, we are conveniently located off of the Merritt Parkway (Exit 35) at 30 Buxton Farms Road in Stamford, CT. Parking is readily available. Pharmagen Labs has been in Stamford for 11 years and recently moved to the new location. If you are out of town, we will ship your prescription via FedEx.