503B Outsourcing Facility

What is a 503B Outsourcing Facility?

A 503B outsourcing facility is a facility that manufactures compounding sterile drugs. A 503B outsourcing facility is registered with the FDA and must undergo rigorous testing due to tighter regulations. Under the direct supervision of a licensed pharmacist, all compounded medications comply with the Current Good Manufacturing Practice (cGMP). All 503b outsourcing facilities are subject to FDA inspections. Prescriptions for individual patients are not needed. 503B outsourcing facilities may compound drugs that are in shortage.

https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm496288.pdf

https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm393571.htm

Central Drugs Outsourcing Facility

Central Drugs Compounding Pharmacy has been the industry expert in IV therapy for many years. Our business has grown and expanded to our new outsourcing facility.

Opened in 2017, Central Drugs Outsourcing Facility is registered with the FDA as a 503b outsourcing facility. We manufacture and distribute compounded sterile medications. Central Drugs Outsourcing Facility is cGMP compliant and our products undergo rigorous testing for potency, purity, and sterility.

We have over 40 products available and growing. Ask about our product list! We're ready to be your #1 sterile injectables provider for office use, hospital, and veterinary clinics. No patient Rx needed!

Open an office account now to place your orders! 

Licensing

Central Drugs Outsourcing Facility is licensed in the following states as a 503B facility. No patient RX needed! Our list continues to grow so please return back frequently for new updates.

Arizona    |    Colorado   |    Connecticut    |    Hawaii    |     Idaho

Iowa    |    Kansas    |    Kentucky    |    Massachusetts    |    New Hampshire

New Jersey    |    New Mexico    |    North Carolina    |    Oregon    |    Pennsylvania

South Dakota    |    Tennessee    |    Texas    |    Washington

Washington DC    |    West Virginia

Don't see your state listed? Our Central Drugs La Habra pharmacy is licensed as a 503A and services over 36 states. As an industry leader since 1999, Central Drugs continues to provide custom quality products and customer service through our 503A pharmacy or 503B outsourcing facility.

FDA Drugs Shortages

Drugs shortages continue to be on the rise as more products become unavailable for patients and practitioners who are in immediate need of them. As manufacturers struggle with delays, obtaining raw materials or supplies, and managing demand, many practitioners must find alternative solutions when a particular product is no longer available.

Sodium bicarbonate, a drug used regularly especially in emergency rooms and cardiology, is currently in shortage. Hospitals across the country are scrambling to find alternative solutions causing surgeries to be placed on hold.

Central Drugs Outsourcing Facility and Central Drugs Compounding Pharmacy is the solution to alleviate the drug shortages impacting health care providers today. We are a compounding pharmacy that can provide the products needed during periods of drug shortages. With 503A and 503B facilities, we are able to accommodate patient-specific requests as well as office orders or hospitals.

Contact us today and ask how we can be your provider during times of drug shortages.

A sample of the products we can assist you with include:

  • MgCl
  • Sodium Bicarbonate
  • CaCl
  • Thiamine
  • Calcium Gluconate

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